Rheumatoid Arthritis

Currently Recruiting

Protocol

Inclusion Summary

A3921192

A phase 3b/4 randomized double blind placebo controlled study of Methotrexate (mtx) withdrawal in subjects with Rheumatoid Arthritis treated with Tofacitinib 11mg modified release formulation

EULAR >6

>4 Tender and swollen joints

Moderate-severe disease activity

Taking MTX >4 months, stable dose for 4 weeks prior to screening. Dose 10-25mg week

Inadequate response to MTX

M14-465

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX

Diagnosis of RA for ≥ 3 months

On MTX ≥ 3 months and on a stable dose of 15-25 mg/week (or ≥ 10mg/week in subjects intolerant of MTX)for ≥ 4 weeks prior to the first dose of study drug.

≥ 6 swollen and tender joints at Screening and Baseline Visits; and hsCRP ≥ 5 mg/L at Screening

≥ 3 bone erosions on x-ray; or ≥ 1 bone erosion and a positive rheumatoid factor (RF); or ≥ 1 bone erosion and a positive anti-cyclic citrullinated peptide (anti-CCP) autoantibody.

Stable dose of NSAIDs, oral corticosteroids (equivalent to prednisone ≤ 10 mg/day) -stable dose ≥ 4 weeks prior to the first dose of study drug

Patients with limited exposure to a bDMARD (< 3 months), or Patients who are responding to a bDMARD but had to discontinue due to intolerability Cessation of bDMARD therapy prior to the first dose of study drug.

Except for MTX, subject must have discontinued all csDMARDs.

Discontinuation of all high-potency opiates at least 1 week and oral traditional Chinese medicine for at least 4 weeks prior to the first dose of study drug.