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

Sponsor
Pfizer
Study ID
NCT02281552
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 18, 2014
Status verified
Mar 2018
Primary completion
Mar 15, 2017
Completion
Mar 15, 2017

Study Design

Enrollment
209 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tofacitinib modified release tablet
  • Active Comparator: tofacitinib immediate release tablet

Primary Outcome Measure

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 ]

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