Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02886728
Registration number
NCT02886728
Ethics application status
Date submitted
29/08/2016
Date registered
1/09/2016
Titles & IDs
Public title
Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
Query!
Scientific title
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy
Query!
Secondary ID [1]
0
0
2016-000570-37
Query!
Secondary ID [2]
0
0
GS-US-417-0303
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
FINCH 3
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib
Treatment: Drugs - MTX
Treatment: Drugs - Placebo to match MTX
Experimental: Filgotinib 200 mg + MTX - Filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg
Experimental: Filgotinib 100 mg + MTX - Filgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg
Experimental: Filgotinib 200 mg Monotherapy - Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX
Active comparator: MTX Monotherapy - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg
Treatment: Drugs: Filgotinib
Tablet(s) administered orally once daily
Treatment: Drugs: Placebo to match filgotinib
Tablet(s) administered orally once daily
Treatment: Drugs: MTX
Capsule(s) administered orally once weekly
Treatment: Drugs: Placebo to match MTX
Capsule(s) administered orally once weekly
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24
Query!
Assessment method [1]
0
0
ACR20 response is achieved when the participant has: = 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity); subject's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain); health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
Query!
Timepoint [1]
0
0
Week 24
Query!
Secondary outcome [1]
0
0
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Query!
Assessment method [1]
0
0
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 \[0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices\]. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 \[0 (no disability) to 3 (completely disabled)\] when 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability).
Query!
Timepoint [1]
0
0
Baseline; Week 24
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24
Query!
Assessment method [2]
0
0
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Query!
Timepoint [2]
0
0
Week 24
Query!
Secondary outcome [3]
0
0
Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24
Query!
Assessment method [3]
0
0
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet \[where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion\]). JSN is scored from 0 to 4 \[0 indicating no/normal JSN and 4 indicating complete loss of joint space\]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
Query!
Timepoint [3]
0
0
Baseline; Week 24
Query!
Secondary outcome [4]
0
0
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Query!
Assessment method [4]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Query!
Timepoint [4]
0
0
Baseline; Week 24
Query!
Secondary outcome [5]
0
0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24
Query!
Assessment method [5]
0
0
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue).
Query!
Timepoint [5]
0
0
Baseline; Week 24
Query!
Secondary outcome [6]
0
0
Change From Baseline in the mTSS at Week 52
Query!
Assessment method [6]
0
0
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range \[0-448\]) is defined as the erosion score (range \[0-280\]) plus the joint space narrowing (JSN) score (range \[0-168\]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet \[where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion\]). JSN is scored from 0 to 4 \[0 indicating no/normal JSN and 4 indicating complete loss of joint space\]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
Query!
Timepoint [6]
0
0
Baseline; Week 52
Query!
Secondary outcome [7]
0
0
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52
Query!
Assessment method [7]
0
0
ACR20 response is achieved when the participant has: = 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders.
Query!
Timepoint [7]
0
0
Weeks 2, 4, 12, 36, and 52
Query!
Secondary outcome [8]
0
0
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [8]
0
0
ACR50 response is achieved when the participant has: = 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders.
Query!
Timepoint [8]
0
0
Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [9]
0
0
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [9]
0
0
ACR70 response is achieved when the participant has: = 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; hsCRP. Participants with missing outcomes were set as non-responders.
Query!
Timepoint [9]
0
0
Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [10]
0
0
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52
Query!
Assessment method [10]
0
0
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement (less disability).
Query!
Timepoint [10]
0
0
Baseline; Weeks 2, 4, 12, 36, and 52
Query!
Secondary outcome [11]
0
0
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [11]
0
0
TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement.
Query!
Timepoint [11]
0
0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [12]
0
0
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [12]
0
0
The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
Query!
Timepoint [12]
0
0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [13]
0
0
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [13]
0
0
SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Query!
Timepoint [13]
0
0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [14]
0
0
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [14]
0
0
PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Query!
Timepoint [14]
0
0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [15]
0
0
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [15]
0
0
The participant assessed their pain severity using a VAS on a scale of 0 ( no pain) to 100 (severe pain). A negative change from baseline indicates improvement.
Query!
Timepoint [15]
0
0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [16]
0
0
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [17]
0
0
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [17]
0
0
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 \[0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 \[0 (no disability) to 3 (completely disabled)\] when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) = 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders.
Query!
Timepoint [17]
0
0
Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [18]
0
0
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [18]
0
0
The DAS28 score is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), Patient's Global Assessment of Disease Activity (VAS: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Query!
Timepoint [18]
0
0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [19]
0
0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 4, 12, 24, and 52
Query!
Assessment method [19]
0
0
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Query!
Timepoint [19]
0
0
Weeks 4, 12, 24, and 52
Query!
Secondary outcome [20]
0
0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52
Query!
Assessment method [20]
0
0
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Query!
Timepoint [20]
0
0
Weeks 2, 4, 12, 36, and 52
Query!
Secondary outcome [21]
0
0
ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [21]
0
0
ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and CRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement.
Query!
Timepoint [21]
0
0
Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [22]
0
0
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [22]
0
0
Good Response: DAS28(CRP) at visit =3.2 and improvement from baseline \>1.2. Moderate Response: DAS28(CRP) at visit =3.2 and improvement from baseline \>0.6 and =1.2; DAS28(CRP) at visit \>3.2 and =5.1 and improvement from baseline \>0.6; DAS 28(CRP) at visit \>5.1 and improvement from baseline \>1.2.
No Response: DAS28(CRP) at visit =5.1 and improvement from baseline =0.6; DAS 28(CRP) \>5.1 at visit and improvement from baseline =1.2.
Query!
Timepoint [22]
0
0
Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [23]
0
0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [23]
0
0
CDAI is calculated using formula: CDAI = TJC28 + SJC28 + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status.
Query!
Timepoint [23]
0
0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [24]
0
0
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52
Query!
Assessment method [24]
0
0
SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. Higher score indicates more severe disease activity status and total possible score is 86. A negative change from baseline indicates improvement.
Query!
Timepoint [24]
0
0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Query!
Secondary outcome [25]
0
0
Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52
Query!
Assessment method [25]
0
0
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS = 0.5, Change in mTSS = 0 and Change in mTSS = smallest detectable change (SDC).
Query!
Timepoint [25]
0
0
Baseline; Weeks 24, and 52
Query!
Secondary outcome [26]
0
0
SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [26]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Query!
Timepoint [26]
0
0
Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [27]
0
0
Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52
Query!
Assessment method [27]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Query!
Timepoint [27]
0
0
Baseline; Weeks 4, 12, 36, and 52
Query!
Secondary outcome [28]
0
0
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [28]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Query!
Timepoint [28]
0
0
Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [29]
0
0
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [29]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Query!
Timepoint [29]
0
0
Baseline; Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [30]
0
0
FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [30]
0
0
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scale for a total possible score of 52.
Query!
Timepoint [30]
0
0
Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [31]
0
0
Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52
Query!
Assessment method [31]
0
0
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue).
Query!
Timepoint [31]
0
0
Baseline; Weeks 4, 12, 36, and 52
Query!
Secondary outcome [32]
0
0
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [32]
0
0
The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Query!
Timepoint [32]
0
0
Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [33]
0
0
EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [33]
0
0
EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Query!
Timepoint [33]
0
0
Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [34]
0
0
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [34]
0
0
The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health).
Query!
Timepoint [34]
0
0
Baseline; Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [35]
0
0
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [35]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [35]
0
0
Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [36]
0
0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [36]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [36]
0
0
Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [37]
0
0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [37]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [37]
0
0
Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [38]
0
0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [38]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [38]
0
0
Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [39]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [39]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [39]
0
0
Baseline; Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [40]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [40]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [40]
0
0
Baseline; Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [41]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [41]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [41]
0
0
Baseline; Weeks 4, 12, 24, 36, and 52
Query!
Secondary outcome [42]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Query!
Assessment method [42]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [42]
0
0
Baseline; Weeks 4, 12, 24, 36, and 52
Query!
Eligibility
Key inclusion criteria
Key
* Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria) and are ACR functional class I-III.
* Have = 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and = 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
* Limited or no prior treatment with MTX
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Previous treatment with any janus kinase (JAK) inhibitor
* Previous therapy for longer than 3 months with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine
* Use of any licensed or investigational biologic disease-modifying antirheumatic drugs (DMARDs)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
8/08/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/05/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1252
Query!
Recruitment in Australia
Recruitment state(s)
QLD,TAS,WA
Query!
Recruitment hospital [1]
0
0
- Maroochydore
Query!
Recruitment hospital [2]
0
0
- Hobart
Query!
Recruitment hospital [3]
0
0
- Victoria Park
Query!
Recruitment postcode(s) [1]
0
0
- Maroochydore
Query!
Recruitment postcode(s) [2]
0
0
- Hobart
Query!
Recruitment postcode(s) [3]
0
0
- Victoria Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kansas
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Minnesota
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Mississippi
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nebraska
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Hampshire
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Jersey
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Mexico
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Buenos Aires
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Caba
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Mendoza
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Quilmes
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
San Fernando
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
San Juan
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
San Miguel de Tucumán
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Flemish Brabant
Query!
Country [32]
0
0
Belgium
Query!
State/province [32]
0
0
Genk
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Hasselt
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Merksem
Query!
Country [35]
0
0
Bulgaria
Query!
State/province [35]
0
0
Dobrich
Query!
Country [36]
0
0
Bulgaria
Query!
State/province [36]
0
0
Haskovo
Query!
Country [37]
0
0
Bulgaria
Query!
State/province [37]
0
0
Plovdiv
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Sofia
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Varna
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Vidin
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Ontario
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Quebec
Query!
Country [43]
0
0
Chile
Query!
State/province [43]
0
0
Santiago
Query!
Country [44]
0
0
Chile
Query!
State/province [44]
0
0
Temuco
Query!
Country [45]
0
0
Czechia
Query!
State/province [45]
0
0
Ostrava
Query!
Country [46]
0
0
Czechia
Query!
State/province [46]
0
0
Prague 2
Query!
Country [47]
0
0
Czechia
Query!
State/province [47]
0
0
Praha 4
Query!
Country [48]
0
0
Czechia
Query!
State/province [48]
0
0
Uherske Hradiste
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Aachen
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Hamburg
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Ratingen
Query!
Country [52]
0
0
Hong Kong
Query!
State/province [52]
0
0
Hong Kong
Query!
Country [53]
0
0
Hong Kong
Query!
State/province [53]
0
0
Tuen Mun
Query!
Country [54]
0
0
Hungary
Query!
State/province [54]
0
0
Bacs-Kiskun
Query!
Country [55]
0
0
Hungary
Query!
State/province [55]
0
0
Fejer
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Budapest
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Kistarcsa
Query!
Country [58]
0
0
India
Query!
State/province [58]
0
0
Ahmedabad
Query!
Country [59]
0
0
India
Query!
State/province [59]
0
0
Bangalore
Query!
Country [60]
0
0
India
Query!
State/province [60]
0
0
Delhi
Query!
Country [61]
0
0
India
Query!
State/province [61]
0
0
Jaipur
Query!
Country [62]
0
0
India
Query!
State/province [62]
0
0
Kolkata
Query!
Country [63]
0
0
India
Query!
State/province [63]
0
0
Lucknow
Query!
Country [64]
0
0
India
Query!
State/province [64]
0
0
Mangalore
Query!
Country [65]
0
0
India
Query!
State/province [65]
0
0
Mysuru
Query!
Country [66]
0
0
India
Query!
State/province [66]
0
0
Nagpur
Query!
Country [67]
0
0
India
Query!
State/province [67]
0
0
New Delhi
Query!
Country [68]
0
0
India
Query!
State/province [68]
0
0
Pune
Query!
Country [69]
0
0
India
Query!
State/province [69]
0
0
Secunderabad
Query!
Country [70]
0
0
India
Query!
State/province [70]
0
0
Srikakulam
Query!
Country [71]
0
0
India
Query!
State/province [71]
0
0
Surat
Query!
Country [72]
0
0
India
Query!
State/province [72]
0
0
Vadodara
Query!
Country [73]
0
0
India
Query!
State/province [73]
0
0
Visakhapatnam
Query!
Country [74]
0
0
Ireland
Query!
State/province [74]
0
0
Dublin 4
Query!
Country [75]
0
0
Israel
Query!
State/province [75]
0
0
Peta? Tiqwa
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Bologna
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Reggio Emilia
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Fukuoka
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Hamamatsu
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Hiroshima
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Kagoshima
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Kato
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Kawagoe
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Miyagi
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Nagaoka
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Nagasaki
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Okayama
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Sanuki
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Sapporo
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Sasebo
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Sayama
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Tokyo
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Ome
Query!
Country [94]
0
0
Korea, Republic of
Query!
State/province [94]
0
0
Anyang-si
Query!
Country [95]
0
0
Korea, Republic of
Query!
State/province [95]
0
0
Daegu
Query!
Country [96]
0
0
Korea, Republic of
Query!
State/province [96]
0
0
Daejeon
Query!
Country [97]
0
0
Korea, Republic of
Query!
State/province [97]
0
0
Incheon
Query!
Country [98]
0
0
Korea, Republic of
Query!
State/province [98]
0
0
Seoul
Query!
Country [99]
0
0
Malaysia
Query!
State/province [99]
0
0
Batu Caves
Query!
Country [100]
0
0
Malaysia
Query!
State/province [100]
0
0
Kuala Lumpur
Query!
Country [101]
0
0
Mexico
Query!
State/province [101]
0
0
Yucatan
Query!
Country [102]
0
0
Mexico
Query!
State/province [102]
0
0
Chihuahua
Query!
Country [103]
0
0
Mexico
Query!
State/province [103]
0
0
Distrito Federal
Query!
Country [104]
0
0
Mexico
Query!
State/province [104]
0
0
Monterrey
Query!
Country [105]
0
0
Mexico
Query!
State/province [105]
0
0
Morelia
Query!
Country [106]
0
0
Mexico
Query!
State/province [106]
0
0
Mérida
Query!
Country [107]
0
0
New Zealand
Query!
State/province [107]
0
0
Canterbury
Query!
Country [108]
0
0
New Zealand
Query!
State/province [108]
0
0
Hamilton
Query!
Country [109]
0
0
New Zealand
Query!
State/province [109]
0
0
Newtown
Query!
Country [110]
0
0
New Zealand
Query!
State/province [110]
0
0
Papatoetoe
Query!
Country [111]
0
0
Poland
Query!
State/province [111]
0
0
Bialystok
Query!
Country [112]
0
0
Poland
Query!
State/province [112]
0
0
Bydgoszcz
Query!
Country [113]
0
0
Poland
Query!
State/province [113]
0
0
Bytom
Query!
Country [114]
0
0
Poland
Query!
State/province [114]
0
0
Dabrówka
Query!
Country [115]
0
0
Poland
Query!
State/province [115]
0
0
Elblag
Query!
Country [116]
0
0
Poland
Query!
State/province [116]
0
0
Gdynia
Query!
Country [117]
0
0
Poland
Query!
State/province [117]
0
0
Katowice
Query!
Country [118]
0
0
Poland
Query!
State/province [118]
0
0
Krakow
Query!
Country [119]
0
0
Poland
Query!
State/province [119]
0
0
Nowa Sól
Query!
Country [120]
0
0
Poland
Query!
State/province [120]
0
0
Poznan
Query!
Country [121]
0
0
Poland
Query!
State/province [121]
0
0
Torun
Query!
Country [122]
0
0
Poland
Query!
State/province [122]
0
0
Warszawa
Query!
Country [123]
0
0
Romania
Query!
State/province [123]
0
0
Mures
Query!
Country [124]
0
0
Romania
Query!
State/province [124]
0
0
Bucharest
Query!
Country [125]
0
0
Romania
Query!
State/province [125]
0
0
Oradea
Query!
Country [126]
0
0
Russian Federation
Query!
State/province [126]
0
0
Barnaul
Query!
Country [127]
0
0
Russian Federation
Query!
State/province [127]
0
0
Kemerovo
Query!
Country [128]
0
0
Russian Federation
Query!
State/province [128]
0
0
Moscow
Query!
Country [129]
0
0
Russian Federation
Query!
State/province [129]
0
0
Nizhniy Novgorod
Query!
Country [130]
0
0
Russian Federation
Query!
State/province [130]
0
0
Saratov
Query!
Country [131]
0
0
Russian Federation
Query!
State/province [131]
0
0
Yaroslavl
Query!
Country [132]
0
0
Serbia
Query!
State/province [132]
0
0
Belgrade
Query!
Country [133]
0
0
Slovakia
Query!
State/province [133]
0
0
Bratislava
Query!
Country [134]
0
0
Slovakia
Query!
State/province [134]
0
0
Prievidza
Query!
Country [135]
0
0
Slovakia
Query!
State/province [135]
0
0
Topol'cany
Query!
Country [136]
0
0
South Africa
Query!
State/province [136]
0
0
Cape Town
Query!
Country [137]
0
0
South Africa
Query!
State/province [137]
0
0
Durban
Query!
Country [138]
0
0
Spain
Query!
State/province [138]
0
0
Barcelona
Query!
Country [139]
0
0
Spain
Query!
State/province [139]
0
0
Barakaldo
Query!
Country [140]
0
0
Spain
Query!
State/province [140]
0
0
La Coruña
Query!
Country [141]
0
0
Spain
Query!
State/province [141]
0
0
Málaga
Query!
Country [142]
0
0
Spain
Query!
State/province [142]
0
0
Sabadell
Query!
Country [143]
0
0
Spain
Query!
State/province [143]
0
0
Santiago de Compostela
Query!
Country [144]
0
0
Spain
Query!
State/province [144]
0
0
Valencia
Query!
Country [145]
0
0
Taiwan
Query!
State/province [145]
0
0
Kaohsiung
Query!
Country [146]
0
0
Taiwan
Query!
State/province [146]
0
0
Taichung
Query!
Country [147]
0
0
Taiwan
Query!
State/province [147]
0
0
Tainan
Query!
Country [148]
0
0
Taiwan
Query!
State/province [148]
0
0
Taipei
Query!
Country [149]
0
0
Taiwan
Query!
State/province [149]
0
0
Taoyuan
Query!
Country [150]
0
0
Thailand
Query!
State/province [150]
0
0
Bangkok
Query!
Country [151]
0
0
Thailand
Query!
State/province [151]
0
0
Chiang Mai
Query!
Country [152]
0
0
Thailand
Query!
State/province [152]
0
0
Songkhla
Query!
Country [153]
0
0
Ukraine
Query!
State/province [153]
0
0
Dnipro
Query!
Country [154]
0
0
Ukraine
Query!
State/province [154]
0
0
Kharkiv
Query!
Country [155]
0
0
Ukraine
Query!
State/province [155]
0
0
Kherson
Query!
Country [156]
0
0
Ukraine
Query!
State/province [156]
0
0
Kyiv
Query!
Country [157]
0
0
Ukraine
Query!
State/province [157]
0
0
L'viv
Query!
Country [158]
0
0
Ukraine
Query!
State/province [158]
0
0
Vinnitsa
Query!
Country [159]
0
0
Ukraine
Query!
State/province [159]
0
0
Vinnytsya
Query!
Country [160]
0
0
Ukraine
Query!
State/province [160]
0
0
Zaporizhzhya
Query!
Country [161]
0
0
United Kingdom
Query!
State/province [161]
0
0
Edinburgh
Query!
Country [162]
0
0
United Kingdom
Query!
State/province [162]
0
0
Newcastle upon Tyne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Gilead Sciences
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Galapagos NV
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
Query!
Trial website
https://clinicaltrials.gov/study/NCT02886728
Query!
Trial related presentations / publications
Westhovens R, Rigby W, van der Heijde D, Ching D, Bartok B, Matzkies F, et al. Efficacy and safety of filgotinib for patients with rheumatoid arthritis naive to methotrexate therapy: FINCH 3 primary outcome results. Ann Rheum Dis 2019; 78 (supplement 2): A259. Tanaka Y, Atsumi T, Aletaha D, Bartok B, Pechonkina A, Han L, Emoto K, Kano S, Rajendran V, Takeuchi T. Benefit of Filgotinib, a JAK1 Preferential Inhibitor, in Rheumatoid Arthritis Patients with Previous Rapid Radiographic Progression: Post Hoc Analysis of Two Trials. Rheumatol Ther. 2023 Feb;10(1):161-185. doi: 10.1007/s40744-022-00503-3. Epub 2022 Nov 3. Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7. Bingham CO 3rd, Walker D, Nash P, Lee SJ, Ye L, Hu H, Khalid JM, Combe B. The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies. Arthritis Res Ther. 2022 Jan 3;24(1):11. doi: 10.1186/s13075-021-02677-7. Aletaha D, Westhovens R, Gaujoux-Viala C, Adami G, Matsumoto A, Bird P, Messina OD, Buch MH, Bartok B, Yin Z, Guo Y, Hendrikx T, Burmester GR. Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3. RMD Open. 2021 Aug;7(2):e001621. doi: 10.1136/rmdopen-2021-001621. Westhovens R, Rigby WFC, van der Heijde D, Ching DWT, Stohl W, Kay J, Chopra A, Bartok B, Matzkies F, Yin Z, Guo Y, Tasset C, Sundy JS, Jahreis A, Mozaffarian N, Messina OD, Landewe RB, Atsumi T, Burmester GR. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. 2021 Jun;80(6):727-738. doi: 10.1136/annrheumdis-2020-219213. Epub 2021 Jan 15.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/28/NCT02886728/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/28/NCT02886728/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Westhovens R, Rigby W, van der Heijde D, Ching D, ...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT02886728