Study to Evaluate the Efficacy of Adalimumab in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints

Phase 2

Completed

• Conditions: Erosive Osteo-Arthritis
• Interventions: Drug: Adalimumab (40 mg sc every other week); Drug: Placebo

• Registration Number: NCT00296894
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Patients will be randomized into two groups (1/1) during one year:

* 40 mg adalimumab subcutaneously (sc) every other week

* placebo

The effect on x-rays and clinical parameters will be evaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-24
• Study First Submitted QC: 2006-02-24
• Study First Posted: 2006-02-27
• Study Start: 2006-05
• Primary Completion: 2009-01
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clear erosive image on x-ray of at least one interphalangeal finger joint

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Adalimumab (40 mg sc every other week)	Drug - adalimimab sc
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Evaluation of x-rays
Evaluation of clinical parameters (pain, daily functioning, etc.)

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium