Status:
COMPLETED
Adalimumab for Inflammatory Osteoarthritis
Lead Sponsor:
University of Alberta
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
Brief Summary
We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.
Detailed Description
This is a 20 patient pilot open-label study of the efficacy of adalimumab in inflammatory osteoarthritis of the knee. Primary endpoint is at 12 weeks and primary outcome is the OARSI responder index.
Eligibility Criteria
Inclusion
- Patient is 40 years of age or older.
- If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse
- If patient is female and of childbearing potential, the results of a serum pregnancy test performed at Screening, prior to the first dose of adalimumab, must be negative.
- Patient has a diagnosis of OA of the index knee according to American College of Rheumatology criteria, including radiological evidence of OA (Kellgren-Lawrence grades 2 or 3).
- Patient has had continual pain for at least 6 months prior to inclusion in the study. This includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month:acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an NSAID, acetaminophen/codeine combination (i.e. Tylenol No 2, 3, 4) taken at least 3 times daily
- Patient has had daily knee pain for the month preceding study enrolment.
- Patient has a summed pain score of 125-400mm (visual analog scale) on the WOMAC pain sub-scale in the index (more symptomatic) knee.
- Patient has clinical evidence of a knee effusion in the index (more symptomatic) knee at Screening and Baseline.
Exclusion
- Subject has a history of an allergic reaction or significant sensitivity to constituents of Adalimumab.
- Patient has a history of proven systemic arthritis such as rheumatoid arthritis.
- Patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee OA
- Patient has predominant patellofemoral disease
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00686439
Start Date
June 1 2008
End Date
November 1 2010
Last Update
June 14 2012
Active Locations (1)
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1
The University of Alberta Hospital
Edmonton, Alberta, Canada, T6G-2B7