A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

This study has been completed.
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
First received: September 9, 2005
Last updated: March 23, 2006
Last verified: March 2006
A 12 week trial of Adalimumab in subjects with active erosive inflammatory OA who have ahd an inadequate response to NSAID therapy

Condition Intervention Phase
Drug: Adalimumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • 20% ACR response

Estimated Enrollment: 12
Study Start Date: June 2005
Estimated Study Completion Date: January 2006

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 45 or older, >/=2 tender and 2 swollen joints, inadequate response to NSAID therapy, hand radiographs with evidence of erosive changes, acceptable form of birth control

Exclusion Criteria:

  • Autoimmune arthropathy, History of psoriasis, Previous TNF therapy, current use of any DMARD, evidence of TB, history of Hep C, B, or HIV
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00185562

United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Mark C Genovese, MD Stanford University
  More Information

ClinicalTrials.gov Identifier: NCT00185562     History of Changes
Other Study ID Numbers: 03-033 
Study First Received: September 9, 2005
Last Updated: March 23, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:

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

ClinicalTrials.gov processed this record on May 01, 2016