A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION
A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION
This study is designed to evaluate the efficacy and safety of tofacitinib modified release formulation (11mg QD) versus tofacitinib modified release formulation plus continued methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are insufficiently responding to their stable dose of methotrexate treatment.
Key Inclusion Criteria
- Must be 18 years of age or older.
Have a score of 6 or greater on the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis at and/or prior to Screening Visit.
Key Exclusion Criteria
Jacksonville, Florida 32207, United States
Voorhees Township, New Jersey 08043, United States
Wall, New Jersey 07719, United States
Summerville, South Carolina 29486, United States
Plovdiv, 4000, Bulgaria
Mexico City, Mexico City 11850, Mexico
Quezon City, National Capital Region 1118, Philippines
Moscow, 115522, Russia
Yaroslavl, 150062, Russia
Seoul, 06591, South Korea
Metropolitan Borough of Wirral, Merseyside CH49 5PE, United Kingdom
Metropolitan Borough of Wirral, Merseyside CH49 5PE, United Kingdom
Metropolitan Borough of Wirral, Merseyside CH49 5PE, United Kingdom