A randomized, double blind, placebo-controlled trial to evaluate the clinical efficacy and the structure modifying properties of etanercept 50/25 mg sc weekly in patients with erosive OA of the interphalangeal finger joints.
Recruiting
- Conditions
- 1. Osteoarthritis<br />2. erosive inflammatory hand<br />3. artrose<br />(NLD: erosieve handartrose).
- Registration Number
- NL-OMON20086
- Lead Sponsor
- eiden University Medical Center, The NetherlandsUniversity of Padova, ItalyMedical University of Vienna,AustriaGhent University Hospital, Belgium
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
1. Males and females > 18 years of age;
2. Subjects with inflammatory erosive hand OA;
Exclusion Criteria
1. Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer;
2. Patients suffering from chronic inflammatory rheumatic disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Joint pain over 24 weeks.
- Secondary Outcome Measures
Name Time Method 1. Joint pain over 12 weeks;<br /><br>2. Joint pain over 52 weeks;<br /><br>3. Effect on OA specific and generic physical function and joint stiffness over 12, 24 and 52 weeks;<br /><br>4. Effect on patient global assessment over 24 and 52 weeks;<br /><br>5. Tolerability and safety of etanercept over 24 and 52 weeks;<br /><br>6. Effect on clinical, laboratory, and imaging assessments over 24 and 52 weeks.<br>