Adalimumab for Inflammatory Osteoarthritis
This study has been completed.
Information provided by (Responsible Party):
Walter Maksymowych, University of Alberta
First received: May 26, 2008
Last updated: June 12, 2012
Last verified: June 2012
We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||HUM 06-087: Proof of Concept Study : Adalimumab for the Treatment of Osteoarthritis
Primary Outcome Measures:
- OARSI/OMERACT response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- WOMAC Patient Global MRI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2010 (Final data collection date for primary outcome measure)
subcutaneous injection 40mg on alternate weeks
Other Name: Humira
subcutaneous injection 40mg every other week
Other Name: Humira
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.
|Ages Eligible for Study:
||40 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686439
|The University of Alberta Hospital
|Edmonton, Alberta, Canada, T6G-2B7 |
University of Alberta
||walter p maksymowych, FRCP
||University of Alberta
No publications provided
||Walter Maksymowych, F.R.C.P.(C),Professor of Medicine, Consultant Rheumatologist, University of Alberta
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 26, 2008
||June 12, 2012
||Canada: Health Canada
Keywords provided by University of Alberta:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013