A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

Stanford University

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00185562

03-033

Details and patient eligibility

About

A 12 week trial of Adalimumab in subjects with active erosive inflammatory OA who have ahd an inadequate response to NSAID therapy

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)