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

Official Summary

This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.

Eligibility Requirements

• Minimum Age: 20 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 209 participants

Study Arms

• tofacitinib modified release tablet (EXPERIMENTAL)
• tofacitinib immediate release tablet (ACTIVE_COMPARATOR)

Interventions

• DRUG: Tofacitinib — tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks
• DRUG: Tofacitinib — tofacitinib immediate release 5 mg tablet administered twice a day for 12 weeks

Primary Outcomes

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

Secondary Outcomes

• Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 (Baseline, Week 12)
• Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12 (Week 12)
• Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 (Week 12)
• Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12 (Week 12)
• Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12 (Week 12)

Eligibility 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

Trial Locations

• Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Aichi-ken, Japan
• National Hospital Organization Nagoya Medical Center, Nagoya, Aichi-ken, Japan
• National Hospital Organization Toyohashi Medical Center, Toyohashi, Aichi-ken, Japan
• Yamada Rheumatology Clinic, Matsuyama, Ehime, Japan
• St. Mary's Hospital, Kurume, Fukuoka, Japan
• Gunma Rheumatism Clinic, Takasaki-shi, Gunma, Japan
• Inoue Hospital, Tohrimachi, Takasaki, Gunma, Japan
• Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Hiroshima, Japan
• National Hospital Organization Asahikawa Medical Center, Asahikawa, Hokkaido, Japan
• Katayama Orthopaedic Rheumatology Clinic, Asahikawa, Hokkaido, Japan
• ...and 10 more locations

Study Officials

• Pfizer CT.gov Call Center — STUDY_DIRECTOR
  Pfizer

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