A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02281552
• Date of registration: 30/10/2014
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis
• Scientific title: A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background Methotrexate
• Date of first enrolment: November 18, 2014
• Target sample size: 209
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02281552
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosis of rheumatoid arthritis

- currently taking a stable dose of methotrexate

- no evidence of active or latent or inadequately treated tuberculosis

Exclusion Criteria:

- evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or
allergic disease

- clinically significant infections within the past 6 months



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tofacitinib

Primary Outcome(s)

Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12 [Time Frame: Baseline, Week 12]

Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12 [Time Frame: Week 12]

Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 [Time Frame: Week 12]

Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12 [Time Frame: Week 12]

Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12 [Time Frame: Week 12]

Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12 [Time Frame: Baseline, Week 12]

Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12 [Time Frame: Week 12]

Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12 [Time Frame: Week 12]

Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12 [Time Frame: Week 12]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 [Time Frame: Baseline, Week 12]

Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12 [Time Frame: Week 12]

Secondary ID(s)

A3921215

TOFACITINIB QD P3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02281552