A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185562
First received: September 9, 2005
Last updated: March 23, 2006
Last verified: March 2006
  Purpose

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
Osteoarthritis
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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185562

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

No publications provided

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:
Osteoarthritis

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

ClinicalTrials.gov processed this record on April 17, 2014