Adalimumab for Inflammatory Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Walter Maksymowych, University of Alberta
ClinicalTrials.gov Identifier:
NCT00686439
First received: May 26, 2008
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.


Condition Intervention Phase
Osteoarthritis
Drug: adalimumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HUM 06-087: Proof of Concept Study : Adalimumab for the Treatment of Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Alberta:

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 ]

Enrollment: 20
Study Start Date: June 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adalimumab Drug: adalimumab
subcutaneous injection 40mg on alternate weeks
Other Name: Humira
Drug: adalimumab
subcutaneous injection 40mg every other week
Other Name: Humira

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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

Locations
Canada, Alberta
The University of Alberta Hospital
Edmonton, Alberta, Canada, T6G-2B7
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: walter p maksymowych, FRCP University of Alberta
  More Information

No publications provided

Responsible Party: Walter Maksymowych, F.R.C.P.(C),Professor of Medicine, Consultant Rheumatologist, University of Alberta
ClinicalTrials.gov Identifier: NCT00686439     History of Changes
Other Study ID Numbers: HUM 06-087
Study First Received: May 26, 2008
Last Updated: June 12, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
osteoarthritis
adalimumab
mri

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014