An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective
NCT02566967 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2019-07-05
Summary
This study will evaluate the optimal dose of tofacitinib needed to achieve low disease activity (LDA) or clinical remission as measured by the CDAI score. Once LDA or clinical remission has been achieved, the structural benefit in reducing erosions, synovitis and bone edema as measured by low field MRI will be determined at the same time period by the use of the OMERACT/RAMRIS scoring system
Conditions
Interventions
- DRUG
-
tofacitinib
oral tofacitinib will be taken 2 times daily
Sponsors & Collaborators
-
Norman B. Gaylis, MD
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2017-12-31
- Completion
- 2018-03-20
Countries
- United States
Study Locations
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