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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02092467




Registration number
NCT02092467
Ethics application status
Date submitted
3/03/2014
Date registered
20/03/2014

Titles & IDs
Public title
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
Scientific title
PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
Secondary ID [1] 0 0
2013-003177-99
Secondary ID [2] 0 0
A3921133
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tofacitinib
Treatment: Drugs - tofacitinib
Treatment: Other - adalimumab
Treatment: Other - etanercept

Experimental: Treatment Arm 1 -

Experimental: Treatment Arm 2 -

Active comparator: Treatment Arm 3 - TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.


Treatment: Drugs: tofacitinib
Oral tablet, 5 mg BID

Treatment: Drugs: tofacitinib
Oral tablet, 10 mg BID

Treatment: Other: adalimumab
Pre-filled syringe, 40 mg subcutaneous injection, every other week

Treatment: Other: etanercept
Pre-filled syringe, 50 mg subcutaneous injection, every week
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC)
Timepoint [1] 0 0
Baseline up to last contact date (maximum up to 72 months)
Primary outcome [2] 0 0
Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE)
Timepoint [2] 0 0
Baseline up to last contact date (maximum up to 72 months)
Secondary outcome [1] 0 0
Incidence Rate of Non-fatal Stroke
Timepoint [1] 0 0
Baseline up to last contact date (maximum up to 72 months)
Secondary outcome [2] 0 0
Incidence Rate of Non-fatal Myocardial Infarction
Timepoint [2] 0 0
Baseline up to last contact date (maximum up to 72 months)
Secondary outcome [3] 0 0
Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis
Timepoint [3] 0 0
Baseline up to last contact date (maximum up to 72 months)
Secondary outcome [4] 0 0
Incidence Rate of Adjudicated Hepatic Events
Timepoint [4] 0 0
Baseline up to last contact date (maximum up to 72 months)
Secondary outcome [5] 0 0
Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE)
Timepoint [5] 0 0
Baseline up to last contact date (maximum up to 72 months)
Secondary outcome [6] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [6] 0 0
AEs: Baseline up to minimum of last contact date or last study treatment dose date+28 days (maximum up to 72 months); SAEs: Baseline up to minimum of last contact date (maximum up to 72 months)
Secondary outcome [7] 0 0
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Timepoint [7] 0 0
Baseline up to last contact date (maximum up to 72 months)
Secondary outcome [8] 0 0
Incidence Rate of Adjudicated All-Cause Deaths
Timepoint [8] 0 0
Baseline up to last contact date (maximum up to 72 months)
Secondary outcome [9] 0 0
Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication
Timepoint [9] 0 0
Baseline up to last contact date (maximum up to 72 months)
Secondary outcome [10] 0 0
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Timepoint [10] 0 0
Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Secondary outcome [11] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Timepoint [11] 0 0
Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Secondary outcome [12] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Timepoint [12] 0 0
Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Secondary outcome [13] 0 0
Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria
Timepoint [13] 0 0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Secondary outcome [14] 0 0
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3
Timepoint [14] 0 0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Secondary outcome [15] 0 0
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8
Timepoint [15] 0 0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Secondary outcome [16] 0 0
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11
Timepoint [16] 0 0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Secondary outcome [17] 0 0
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10
Timepoint [17] 0 0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Secondary outcome [18] 0 0
Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2
Timepoint [18] 0 0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Secondary outcome [19] 0 0
Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response
Timepoint [19] 0 0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Secondary outcome [20] 0 0
Number of Participants With an American College of Rheumatology 50% (ACR50) Response
Timepoint [20] 0 0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Secondary outcome [21] 0 0
Number of Participants With an American College of Rheumatology 70% (ACR70) Response
Timepoint [21] 0 0
Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
Secondary outcome [22] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Timepoint [22] 0 0
Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63

Eligibility
Key inclusion criteria
* Moderate to severe rheumatoid arthritis
* Taking methotrexate without adequate control of symptoms
* Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current or recent infection
* Clinically significant laboratory abnormalities
* Pregnancy

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
14/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/07/2020
Sample size
Target
Accrual to date
Final
4372
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [2] 0 0
St. Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [3] 0 0
Austin Health - Repatriation Hospital - Heidelberg West
Recruitment hospital [4] 0 0
Austin Repatriation Hospital - Heidelberg
Recruitment hospital [5] 0 0
RK Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg
Recruitment postcode(s) [5] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
Country [10] 0 0
United States of America
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Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
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Minnesota
Country [18] 0 0
United States of America
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Missouri
Country [19] 0 0
United States of America
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Montana
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United States of America
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Nebraska
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Nevada
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United States of America
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New Hampshire
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New Jersey
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Wisconsin
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Argentina
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Caba
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Santa FE
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Tucuman
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Cordoba
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Rosario
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San Isidro
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BA
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MG
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PR
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RJ
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Pleven
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Ruse
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Varna
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Brno
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Ostrava
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Czechia
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Praha 2
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Praha 4
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Czechia
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Zlin
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Helsinki
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HKG
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Hong Kong
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Kfar Saba
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Israel
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Tel Aviv
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Tel-Hashomer
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Amman
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Irbid
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Sarawak
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Malaysia
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Coahuila
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Distrito Federal
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Jalisco
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Ciudad de Mexico
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San Luis Potosi
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Leeuwarden
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LA Libertad
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Lima
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Podlaskie
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Bydgoszcz
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Elblag
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Gdynia
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Lublin
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Poznan
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Sopot
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Torun
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Russian Federation
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St. Petersburg
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Gauteng
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South Africa
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Stellenbosch
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Spain
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Badajoz
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Spain
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Cantabria
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Spain
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LA Coruna
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Spain
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Vizcaya
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Spain
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Barcelona
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Madrid
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Spain
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Taipei
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Taiwan
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Taoyuan City
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Songkhla
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Turkey
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Ankara
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Aydin
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State/province [172] 0 0
Gaziantep
Country [173] 0 0
Turkey
State/province [173] 0 0
Istanbul
Country [174] 0 0
Turkey
State/province [174] 0 0
Izmir
Country [175] 0 0
Turkey
State/province [175] 0 0
Kocaeli
Country [176] 0 0
Turkey
State/province [176] 0 0
Samsun
Country [177] 0 0
Turkey
State/province [177] 0 0
Sivas
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Dorset
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Essex
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Cannock
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Liverpool
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Newcastle Upon Tyne
Country [183] 0 0
United Kingdom
State/province [183] 0 0
North Shields
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02092467