Methotrexate-Inadequate Response Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis (RA)

In brief

The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

Key facts

Study ID

NCT00559585

Run by

Bristol-Myers Squibb

People needed

2492

Starts

2008-01-01

Expected to finish

2014-09-01

Last updated by the study team

2015-11-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are considered methotrexate inadequate responders
• 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)

You may not qualify if…

• Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies
• Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous)
• Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
• Subjects with severe chronic or recurrent bacterial infections
• Subjects who have received treatment with rituximab
• An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.

Where it is running

• Coastal Clinical Research, Inc — Mobile, Alabama, United States
• Advanced Arthritis Care & Research — Scottsdale, Arizona, United States
• Catalina Pointe Clinical Research, Inc. — Tucson, Arizona, United States
• St. Joseph'S Mercy Clinic — Hot Springs, Arkansas, United States
• Talbert Medical Group — Huntington Beach, California, United States
• Allergy & Rheumatology Medical Clinic, Inc. — La Jolla, California, United States
• Valerius Medical Group &Research Ctr. Of Greater Long Beach — Long Beach, California, United States
• Stanford University School Of Medicine — Palo Alto, California, United States
• San Diego Arthritis Medical Clinic — San Diego, California, United States
• Boulder Medical Center — Boulder, Colorado, United States
• Arthritis Assoc And Osteo Ctr Of Col Sprgs — Colorado Springs, Colorado, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Arthritis Center Of The Rockies, Pc — Loveland, Colorado, United States
• Guadagnoli, Germano — Bridgeport, Connecticut, United States
• Joao Nascimento — Bridgeport, Connecticut, United States
• Clinical Research Center Of Ct/Ny — Danbury, Connecticut, United States
• Arthritis And Rheumatic Disease Specialties — Aventura, Florida, United States
• Arthritis & Osteoporosis Treatment Center, Pa — Orange Park, Florida, United States
• Rheumatology Associates Of Central Florida — Orlando, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• Arthritis & Rheumatology Of Georgia,Pc — Atlanta, Georgia, United States
• Boise Rheumatology/ Intermountain Research Center, Inc — Boise, Idaho, United States
• Coeur D'Alene Arthrit Clin — Coeur d'Alene, Idaho, United States
• Rheumatology Associates, Pc — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.