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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01039688

Registration number

NCT01039688

Ethics application status

Date submitted

23/12/2009

Date registered

25/12/2009

Date last updated

6/04/2018

Titles & IDs

Public title

Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

Scientific title

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

Secondary ID [1]

2009-016987-34

Secondary ID [2]

A3921069

Universal Trial Number (UTN)

Trial acronym

ORAL1069

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Arthritis, Rheumatoid

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Inflammatory and Immune System

Rheumatoid arthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Treatment: Drugs - Disease-modifying antirheumatic drug

Experimental: 5 mg BID CP-690,550 -

Experimental: 10 mg BID CP-690,550 -

Active comparator: methotrexate -

Treatment: Drugs: CP-690,550
Oral tablets administered at a dose of 5 mg BID for 24 months

Treatment: Drugs: CP-690,550
Oral tablets administered at a dose of 10 mg BID for 24 months

Treatment: Drugs: Disease-modifying antirheumatic drug
Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Modified Total Sharp Score (mTSS) at Month 6

Timepoint [1]

Month 6

Primary outcome [2]

Change From Baseline at Month 6 in mTSS

Timepoint [2]

Month 6

Primary outcome [3]

Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6

Timepoint [3]

Month 6

Primary outcome [4]

Absolute Blood Pressure (BP) Values (mmHg)

Timepoint [4]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24

Primary outcome [5]

Change From Baseline in BP Values (mmHg)

Timepoint [5]

Months 1, 2, 3, 6, 9, 12, 15, 18, and 24

Secondary outcome [1]

mTSS Score at Baseline, Months 12 and 24

Timepoint [1]

Baseline, Months 12 and 24

Secondary outcome [2]

Change From Baseline in mTSS Score at Months 12 and 24

Timepoint [2]

Months 12 and 24

Secondary outcome [3]

Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24

Timepoint [3]

Months 6, 12, and 24

Secondary outcome [4]

Percentage of Participants With no Worsening in Erosion Score (Increase =0.5) at Months 6, 12, and 24

Timepoint [4]

Months 6, 12, and 24

Secondary outcome [5]

Erosion Scores

Timepoint [5]

Baseline, Months 6, 12, and 24

Secondary outcome [6]

JSN Scores

Timepoint [6]

Baseline, Months 6, 12, and 24

Secondary outcome [7]

Change From Baseline in Erosion Scores

Timepoint [7]

Months 6, 12, and 24

Secondary outcome [8]

Change From Baseline in JSN Scores

Timepoint [8]

Months 6, 12, and 24

Secondary outcome [9]

Percentage of Participants Achieving an ACR70 Response

Timepoint [9]

Months 1, 2, 3, 9, 12, 15, 18, 21, and 24

Secondary outcome [10]

Percentage of Participants Achieving an ACR20 Response

Timepoint [10]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [11]

Percentage of Participants Achieving an ACR50 Response

Timepoint [11]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [12]

Tender Joints Count (TJC)

Timepoint [12]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [13]

Change From Baseline in TJC

Timepoint [13]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [14]

Swollen Joints Count (SJC)

Timepoint [14]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [15]

Change From Baseline in SJC

Timepoint [15]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [16]

Patient Assessment of Arthritis Pain

Timepoint [16]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [17]

Change From Baseline in Patient Assessment of Arthritis Pain

Timepoint [17]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [18]

Physician Global Assessment of Arthritis

Timepoint [18]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [19]

Change From Baseline in Physician Global Assessment of Arthritis

Timepoint [19]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [20]

Patient Global Assessment of Arthritis

Timepoint [20]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [21]

Change From Baseline in Patient Global Assessment of Arthritis

Timepoint [21]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [22]

C-Reactive Protein

Timepoint [22]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [23]

Change From Baseline in CRP

Timepoint [23]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [24]

Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP

Timepoint [24]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [25]

Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

Timepoint [25]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [26]

Change From Baseline in DAS28-3(CRP)

Timepoint [26]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [27]

Change From Baseline in DAS28-4(ESR)

Timepoint [27]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [28]

Percentage of Participants With DAS28-3(CRP) =3.2

Timepoint [28]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [29]

Percentage of Participants With DAS28-4(ESR) =3.2

Timepoint [29]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [30]

Percentage of Participants With DAS28-3(CRP) <2.6

Timepoint [30]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [31]

Percentage of Participants With DAS28-4(ESR) <2.6

Timepoint [31]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [32]

Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)

Timepoint [32]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [33]

Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)

Timepoint [33]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [34]

Percentage of Participants With an ACR70 Response Sustained at Least 6 Months

Timepoint [34]

Months 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [35]

Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits

Timepoint [35]

Months 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [36]

Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits

Timepoint [36]

Months 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [37]

Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits

Timepoint [37]

Months 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [38]

Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits

Timepoint [38]

Months 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [39]

Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits

Timepoint [39]

Months 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [40]

Health Assessment Questionnaire Disability Index (HAQ-DI)

Timepoint [40]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [41]

Change From Baseline in HAQ-DI Score

Timepoint [41]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [42]

Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score

Timepoint [42]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [43]

Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score

Timepoint [43]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [44]

Percentage of Participants With at Least 0.5 Improvement in HAQ-DI

Timepoint [44]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [45]

Short Form 36 (SF-36) Mental Component Score

Timepoint [45]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [46]

SF-36 Physical Component Score

Timepoint [46]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [47]

Change From Baseline in SF-36 Mental Component Score

Timepoint [47]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [48]

Change From Baseline in SF-36 Physical Component Score

Timepoint [48]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [49]

SF-36 Domain Scores

Timepoint [49]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [50]

Change From Baseline in SF-36 Domain Scores

Timepoint [50]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [51]

Work Limitation Questionnaire (WLQ) Score

Timepoint [51]

Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [52]

Change From Baseline in WLQ Scores

Timepoint [52]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [53]

WLQ Work Loss Index Score

Timepoint [53]

Baseline and Months 3, 6, and 12

Secondary outcome [54]

Change From Baseline in WLQ Work Loss Index Score

Timepoint [54]

Months 3, 6, 12, 15, 18, 21, and 24

Secondary outcome [55]

European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score

Timepoint [55]

Baseline and Months 3, 6, 12, 18, and 24

Secondary outcome [56]

Change From Baseline in EQ-5D Health State Profile Utility Score

Timepoint [56]

Months 3, 6, 12, 18, and 24

Secondary outcome [57]

Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6

Timepoint [57]

Baseline and Months 3 and 6

Secondary outcome [58]

Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24

Timepoint [58]

Months 12, 18, and 24

Secondary outcome [59]

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6

Timepoint [59]

Baseline and Months 3 and 6

Secondary outcome [60]

Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24

Timepoint [60]

Months 12, 18, and 24

Secondary outcome [61]

Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6

Timepoint [61]

Baseline and Months 3 and 6

Secondary outcome [62]

Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24

Timepoint [62]

Months 12, 18, and 24

Secondary outcome [63]

Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6

Timepoint [63]

Baseline and Months 3 and 6

Secondary outcome [64]

Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24

Timepoint [64]

Months 12, 18, and 24

Secondary outcome [65]

Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU

Timepoint [65]

Baseline, Months 3, 6, 12, 18, and 24

Secondary outcome [66]

Change From Baseline in Work Productivity and HCRU at Months 3 and 6

Timepoint [66]

Months 3 and 6

Secondary outcome [67]

Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24

Timepoint [67]

Months 12, 18, and 24

Secondary outcome [68]

Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6

Timepoint [68]

Months 3 and 6

Secondary outcome [69]

Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24

Timepoint [69]

Months 12, 18, and 24

Secondary outcome [70]

Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6

Timepoint [70]

Months 3 and 6

Secondary outcome [71]

Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24

Timepoint [71]

Months 12, 18, and 24

Secondary outcome [72]

Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6

Timepoint [72]

Months 3 and 6

Secondary outcome [73]

Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24

Timepoint [73]

Months 12, 18, and 24

Secondary outcome [74]

Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU

Timepoint [74]

Months 3, 6, 12, 18, and 24

Secondary outcome [75]

Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3

Timepoint [75]

Baseline and Months 1, 2, and 3

Secondary outcome [76]

Percentage of Participants With Optimal Sleep Assessed Using MOS-SS

Timepoint [76]

Months 1, 2, 3, 6, 12, 18, and 24

Secondary outcome [77]

Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24

Timepoint [77]

Months 6, 12, 18, and 24

Secondary outcome [78]

Change From Baseline in MOS-SS at Months 1, 2, and 3

Timepoint [78]

Months 1, 2, and 3

Secondary outcome [79]

Change From Baseline in MOS-SS at Months 6, 12, 18, and 24

Timepoint [79]

Months 6, 12, 18, and 24

Secondary outcome [80]

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale

Timepoint [80]

Baseline and Months 1, 2, 3, 6, 12, 18, and 24

Secondary outcome [81]

Change From Baseline in FACIT-Fatigue Scale

Timepoint [81]

Months 1, 2, 3, 6, 12, 18, and 24

Secondary outcome [82]

Change From Baseline in Heart Rate

Timepoint [82]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary outcome [83]

Change From Baseline in Temperature

Timepoint [83]

Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24

Eligibility

Key inclusion criteria

* Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate.
* Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
* Active disease as defined by both >=6 tender or painful joints on motion and >= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL

Minimum age

18 Years

Maximum age

99 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L
* History of any other rheumatic autoimmune disease other than Sjogren's syndrome
* No malignancy or history of malignancy
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
* No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2010

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/03/2013

Sample size

Target

Accrual to date

Final

956

Recruitment in Australia

Recruitment state(s)

QLD,SA,VIC

Recruitment hospital [1]

Rheumatology Research Unit Sunshine Coast - Maroochydore

Recruitment hospital [2]

The Queen Elizabeth Hospital, Department of Rheumatology - Woodville

Recruitment hospital [3]

Emeritus Research - Malvern East

Recruitment postcode(s) [1]

4558 - Maroochydore

Recruitment postcode(s) [2]

5011 - Woodville

Recruitment postcode(s) [3]

3145 - Malvern East

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Arizona

Country [2]

United States of America

State/province [2]

Arkansas

Country [3]

United States of America

State/province [3]

California

Country [4]

United States of America

State/province [4]

Florida

Country [5]

United States of America

State/province [5]

Indiana

Country [6]

United States of America

State/province [6]

Iowa

Country [7]

United States of America

State/province [7]

Louisiana

Country [8]

United States of America

State/province [8]

Maryland

Country [9]

United States of America

State/province [9]

Massachusetts

Country [10]

United States of America

State/province [10]

Nebraska

Country [11]

United States of America

State/province [11]

New York

Country [12]

United States of America

State/province [12]

North Carolina

Country [13]

United States of America

State/province [13]

Oklahoma

Country [14]

United States of America

State/province [14]

Pennsylvania

Country [15]

United States of America

State/province [15]

South Carolina

Country [16]

United States of America

State/province [16]

Tennessee

Country [17]

United States of America

State/province [17]

Texas

Country [18]

United States of America

State/province [18]

Washington

Country [19]

United States of America

State/province [19]

West Virginia

Country [20]

Argentina

State/province [20]

Buenos Aires

Country [21]

Belgium

State/province [21]

Gent

Country [22]

Brazil

State/province [22]

Country [23]

Brazil

State/province [23]

Country [24]

Brazil

State/province [24]

Country [25]

Brazil

State/province [25]

Country [26]

Brazil

State/province [26]

Rio de Janeiro

Country [27]

Bulgaria

State/province [27]

Plovdiv

Country [28]

Bulgaria

State/province [28]

Ruse

Country [29]

Bulgaria

State/province [29]

Sofia

Country [30]

Bulgaria

State/province [30]

Veliko Tarnovo

Country [31]

Canada

State/province [31]

Alberta

Country [32]

Canada

State/province [32]

British Columbia

Country [33]

Canada

State/province [33]

Manitoba

Country [34]

Canada

State/province [34]

Ontario

Country [35]

Chile

State/province [35]

IX Region

Country [36]

Chile

State/province [36]

Country [37]

Chile

State/province [37]

V Region

Country [38]

Chile

State/province [38]

Rancagua

Country [39]

Colombia

State/province [39]

Atlantico

Country [40]

Colombia

State/province [40]

Cundinamarca

Country [41]

Colombia

State/province [41]

Santander

Country [42]

Costa Rica

State/province [42]

Cartago

Country [43]

Costa Rica

State/province [43]

San Jose

Country [44]

Czechia

State/province [44]

Brno - Zidenice

Country [45]

Czechia

State/province [45]

Brno

Country [46]

Czechia

State/province [46]

Hradec Kralove

Country [47]

Czechia

State/province [47]

Ostrava-Poruba

Country [48]

Czechia

State/province [48]

Praha 2

Country [49]

Czechia

State/province [49]

Praha 4

Country [50]

Dominican Republic

State/province [50]

Santo Domingo

Country [51]

Germany

State/province [51]

Aachen

Country [52]

Germany

State/province [52]

Berlin

Country [53]

Germany

State/province [53]

Erlangen

Country [54]

Germany

State/province [54]

Halle

Country [55]

Germany

State/province [55]

Hamburg

Country [56]

Germany

State/province [56]

Nuernberg

Country [57]

Germany

State/province [57]

Ratingen

Country [58]

Germany

State/province [58]

Rheine

Country [59]

Hungary

State/province [59]

Balatonfüred

Country [60]

Hungary

State/province [60]

Budapest

Country [61]

Hungary

State/province [61]

Mezokovesd

Country [62]

Hungary

State/province [62]

Szolnok

Country [63]

India

State/province [63]

Andhra Pradesh

Country [64]

India

State/province [64]

Gujarat

Country [65]

India

State/province [65]

Karnataka

Country [66]

India

State/province [66]

Maharashtra

Country [67]

India

State/province [67]

Ahmedabad

Country [68]

Korea, Republic of

State/province [68]

Seoul

Country [69]

Malaysia

State/province [69]

Negeri Sembilan

Country [70]

Malaysia

State/province [70]

Selangor Darul Ehsan

Country [71]

Malaysia

State/province [71]

Kuching

Country [72]

Mexico

State/province [72]

Coahuila

Country [73]

Mexico

State/province [73]

Jalisco

Country [74]

Mexico

State/province [74]

Nuevo LEON

Country [75]

New Zealand

State/province [75]

Auckland

Country [76]

New Zealand

State/province [76]

Christchurch

Country [77]

New Zealand

State/province [77]

Hamilton

Country [78]

New Zealand

State/province [78]

Timaru

Country [79]

Peru

State/province [79]

Callao

Country [80]

Peru

State/province [80]

Lima

Country [81]

Philippines

State/province [81]

Cebu City

Country [82]

Philippines

State/province [82]

Davao City

Country [83]

Philippines

State/province [83]

Manila

Country [84]

Poland

State/province [84]

Gdynia

Country [85]

Poland

State/province [85]

Katowice

Country [86]

Poland

State/province [86]

Warszawa

Country [87]

Puerto Rico

State/province [87]

Ponce

Country [88]

Russian Federation

State/province [88]

Barnaul

Country [89]

Russian Federation

State/province [89]

Ekaterinburg

Country [90]

Russian Federation

State/province [90]

Kemerovo

Country [91]

Russian Federation

State/province [91]

Novosibirsk

Country [92]

Russian Federation

State/province [92]

Saint Petersburg

Country [93]

Russian Federation

State/province [93]

Smolensk

Country [94]

Russian Federation

State/province [94]

St. Petersburg

Country [95]

Russian Federation

State/province [95]

Tomsk

Country [96]

Slovakia

State/province [96]

Bratislava

Country [97]

Slovakia

State/province [97]

Dunajska Streda

Country [98]

Slovakia

State/province [98]

Nove Zamky

Country [99]

Slovakia

State/province [99]

Piestany

Country [100]

Slovakia

State/province [100]

Zilina

Country [101]

Spain

State/province [101]

A Coruña

Country [102]

Spain

State/province [102]

Vizcaya

Country [103]

Spain

State/province [103]

Madrid

Country [104]

Spain

State/province [104]

Malaga

Country [105]

Spain

State/province [105]

Sevilla

Country [106]

Sweden

State/province [106]

Malmo

Country [107]

Sweden

State/province [107]

Sundsvall

Country [108]

Sweden

State/province [108]

Uppsala

Country [109]

Taiwan

State/province [109]

Kaohsiung

Country [110]

Taiwan

State/province [110]

Taichung

Country [111]

Taiwan

State/province [111]

Tainan

Country [112]

Thailand

State/province [112]

Bangkok

Country [113]

Ukraine

State/province [113]

Crimea

Country [114]

Ukraine

State/province [114]

Kyiv

Country [115]

Ukraine

State/province [115]

Lviv

Country [116]

Ukraine

State/province [116]

Odesa

Country [117]

Ukraine

State/province [117]

Vinnitsa

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Pfizer

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Trial website

https://clinicaltrials.gov/study/NCT01039688

Trial related presentations / publications

Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.
Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
Bykerk VP, Lee EB, van Vollenhoven R, Gruben DC, Fallon L, Woolcott JC, Keystone E. Identification of Distinct Disease Activity Trajectories in Methotrexate-Naive Patients With Rheumatoid Arthritis Receiving Tofacitinib Over Twenty-Four Months. Arthritis Care Res (Hoboken). 2022 Jan;74(1):131-141. doi: 10.1002/acr.24709.
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.
van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z.
Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.
Strand V, Kavanaugh A, Kivitz AJ, van der Heijde D, Kwok K, Akylbekova E, Soonasra A, Snyder M, Connell C, Bananis E, Smolen JS. Long-Term Radiographic and Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Treated with Tofacitinib: ORAL Start and ORAL Scan Post-hoc Analyses. Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7. Epub 2018 May 14.
van Vollenhoven RF, Lee EB, Fallon L, Zwillich SH, Wilkinson B, Chapman D, DeMasi R, Keystone E. Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. Arthritis Care Res (Hoboken). 2019 Jan;71(1):71-79. doi: 10.1002/acr.23585.
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.
Fleischmann R, Strand V, Wilkinson B, Kwok K, Bananis E. Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naive patients with rheumatoid arthritis. RMD Open. 2016 Apr 26;2(1):e000232. doi: 10.1136/rmdopen-2015-000232. eCollection 2016.
Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley JD, Gruben D, Koncz T, Krishnaswami S, Wallenstein GV, Zang C, Zwillich SH, van Vollenhoven RF; ORAL Start Investigators. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014 Jun 19;370(25):2377-86. doi: 10.1056/NEJMoa1310476.

Public notes

Contacts

Principal investigator

Name

Pfizer CT.gov Call Center

Address

Pfizer

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01039688

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01039688