RESTART C0168Z05 Rheumatoid Arthritis Study

Completed · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

Key facts

Study ID

NCT00714493

Run by

Centocor Ortho Biotech Services, L.L.C.

People needed

203

Starts

2008-07-01

Expected to finish

2010-06-01

Last updated by the study team

2013-09-12

Who can join

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

You may qualify if…

• Patients must have rheumatoid arthritis
• Patients must have greater than or equal to 6 tender joints and greater than or equal to 6 swollen joints
• Patients must have inadequate disease response to etanercept or adalimumab
• Patients must have received etanercept or adalimumab in combination with methotrexate for a minimum of at least 3 months prior to the screening visit. The last dose of etanercept must have been given at least 1 week but not more than 2 weeks prior to first infliximab infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to first infliximab infusion.

You may not qualify if…

• Patients who have a history of latent or active TB
• Have inflammatory disease other than rheumatoid arthritis
• Have had a chronic or recurrent infectious disease.

Where it is running

• Study site — Paradise Valley, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Santa Monica, California, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Lewes, Delaware, United States
• Study site — Boca Raton, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Moline, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Wheaton, Maryland, United States
• Study site — Saint Clair Shores, Michigan, United States
• Study site — Eagan, Minnesota, United States
• Study site — Springfield, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Berkeley Heights, New Jersey, United States
• Study site — Freehold, New Jersey, United States
• Study site — Albany, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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