Clinical trial NCT00686439: Adalimumab for Inflammatory Osteoarthritis
Official title: HUM 06-087: Proof of Concept Study : Adalimumab for the Treatment of Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Keywords: osteoarthritis
adalimumab
mri
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2008-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: OARSI/OMERACT response
timeFrame: 12 weeks
Secondary outcomes:
measure: WOMAC Patient Global MRI
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: The University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: walter p maksymowych, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maksymowych WP, Russell AS, Chiu P, Yan A, Jones N, Clare T, Lambert RG. Targeting tumour necrosis factor alleviates signs and symptoms of inflammatory osteoarthritis of the knee. Arthritis Res Ther. 2012 Oct 4;14(5):R206. doi: 10.1186/ar4044.