An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02187055
• Date of registration: 08/07/2014
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate ORAL STRATEGY
• Scientific title: A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis
• Date of first enrolment: August 2014
• Target sample size: 1152
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02187055
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Argentina, Australia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, Croatia, Czech Republic, Czechia, Estonia, France, Israel, Korea, Republic of, Latvia, Lithuania, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have moderate to severe rheumatoid arthritis

- On methotrexate but inadequately controlled

- Subjects must not have active tuberculosis or an inadequately treated tuberculosis
infection

- Subjects must use contraception

Exclusion Criteria:

- Subjects who have been previously treated with adalimumab or Tofacitinib

- Subjects with any current malignancy or a history of malignancy, with the exception of
adequately treated or excised non metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.

- Subjects with specific laboratory test abnormalities

- Subjects with specific types of infections



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rhematoid Arthritis

Intervention(s)

Drug: Tofacitinib without methotrexate

Drug: Tofacitinib with methotrexate

Biological: Adalimumab with methotrexate

Primary Outcome(s)

Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 [Time Frame: Month 6]

Secondary Outcome(s)

Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 [Time Frame: Month 6]

Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 [Time Frame: Month 6]

Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 [Time Frame: Month 6]

Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 [Time Frame: Month 6]

Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 [Time Frame: Month 6]

Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 [Time Frame: Month 6]

Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 [Time Frame: Month 6]

Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 [Time Frame: Month 6]

Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving CDAI =10 at Month 6 [Time Frame: Month 6]

Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving CDAI =2.8 at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving DAS28-4 (ESR) =3.2 at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving SDAI =11 at Month 6 [Time Frame: Month 6]

Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 [Time Frame: Month 6]

Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving SDAI =3.3 at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 [Time Frame: Month 6]

Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 [Time Frame: Month 6]

Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 [Time Frame: Month 6]

Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 [Time Frame: Month 6]

Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 [Time Frame: Month 6]

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 [Time Frame: Month 6]

Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving DAS28-4 (CRP) =3.2 at Month 6 [Time Frame: Month 6]

Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 [Time Frame: Month 6]

Secondary ID(s)

2014-000358-13

A3921187

ORAL STRATEGY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/06/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02187055