Adalimumab for Inflammatory Osteoarthritis

Study Overview
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Brief Summary
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We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.

Detailed Description
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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.

Official Title
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HUM 06-087: Proof of Concept Study : Adalimumab for the Treatment of Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: adalimumab
* Drug: adalimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adalimumab<br> | Drug: adalimumab<br>* subcutaneous injection 40mg on alternate weeks<br>* Other names: Humira;Drug: adalimumab<br>* subcutaneous injection 40mg every other week<br>* Other names: Humira;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OARSI/OMERACT response |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Patient Global MRI |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, adalimumab, mri