Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.

Key facts

Study ID

NCT00647270

Run by

Abbott

People needed

420

Starts

2007-12-01

Expected to finish

2009-04-01

Last updated by the study team

2011-04-11

Who can join

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

You may qualify if…

• Subject > 18 years of age
• Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification criteria and has a disease duration for a minimum of three months
• Subject must meet the following two criteria: a) At least 6 swollen joints out of 66 assessed, or b) At least 6 tender joints out of 68 assessed
• If a subject is on MTX, the doses must be stable for at least 4 weeks prior to Screening blood draw and follow standard recommendations for MTX treatment
• Subject is judged to be in generally good health as determined by the principal investigator

You may not qualify if…

• Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol or golimumab) including adalimumab
• Subject has a history of acute inflammatory joint disease of different origin other than RA
• Subject has been treated with any investigational biologic agents
• Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Female subject who is pregnant or breast-feeding or considering becoming pregnant

Where it is running

• Study site — Tuscaloosa, Alabama, United States
• Study site — Paradise Valley, Arizona, United States
• Study site — Hemet, California, United States
• Study site — Long Beach, California, United States
• Study site — Santa Monica, California, United States
• Study site — Torrance, California, United States
• Study site — Victorville, California, United States
• Study site — West Hills, California, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Aventura, Florida, United States
• Study site — Orange Park, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Moline, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Covington, Louisiana, United States
• Study site — Brighton, Michigan, United States
• Study site — Passaic, New Jersey, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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