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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

May 26, 2008
June 12, 2012
June 2008
November 2010   (final data collection date for primary outcome measure)
OARSI/OMERACT response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00686439 on ClinicalTrials.gov Archive Site
WOMAC Patient Global MRI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Adalimumab for Inflammatory Osteoarthritis
HUM 06-087: Proof of Concept Study : Adalimumab for the Treatment of Osteoarthritis

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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
  • Drug: adalimumab
    subcutaneous injection 40mg on alternate weeks
    Other Name: Humira
  • Drug: adalimumab
    subcutaneous injection 40mg every other week
    Other Name: Humira
Experimental: adalimumab
Interventions:
  • Drug: adalimumab
  • Drug: adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00686439
HUM 06-087
No
Walter Maksymowych, University of Alberta
University of Alberta
Not Provided
Principal Investigator: walter p maksymowych, FRCP University of Alberta
University of Alberta
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP