Status:
COMPLETED
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
Lead Sponsor:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The objective of this study is to demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00647270
Start Date
December 1 2007
End Date
April 1 2009
Last Update
April 11 2011
Active Locations (86)
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1
Huntsville, Alabama, United States, 35801
2
Tuscaloosa, Alabama, United States, 35406
3
Paradise Valley, Arizona, United States, 85253
4
Hemet, California, United States, 92543