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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 24, 2014