A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

This study has been completed.

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00185562

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 II

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Adalimumab

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

Further study details as provided by Stanford University:

Primary Outcome Measures:

Secondary Outcome Measures:

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

Eligibility

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

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

Keywords provided by Stanford University:

Osteoarthritis

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Rheumatic Diseases
Adalimumab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009