Adalimumab for Inflammatory Osteoarthritis

NCT ID: NCT00686439

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-11-30

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

adalimumab

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: DRUG

subcutaneous injection 40mg on alternate weeks

adalimumab

Intervention Type: DRUG

subcutaneous injection 40mg every other week

Interventions

adalimumab

subcutaneous injection 40mg on alternate weeks

Intervention Type: DRUG

adalimumab

subcutaneous injection 40mg every other week

Intervention Type: DRUG

Other Intervention Names

Humira; Humira

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Walter Maksymowych

F.R.C.P.(C),Professor of Medicine, Consultant Rheumatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

walter p maksymowych, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

The University of Alberta Hospital

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 23036475 (View on PubMed)

Other Identifiers

HUM 06-087

Identifier Type: -

Identifier Source: org_study_id