The efficacy and safety of intra-articular injections with the TNF-a antagonist infliximab in patients with chronic or recurrent arthritis of the knee.
Recruiting
- Conditions
- recurrent or persistent inflammatory arthritis involving a knee (rheumatoid arthritis, juvenile chronic arthritis, spondylarthropathies and arthritis of unknown origin) despite corticosteroid injections intra-articular
- Registration Number
- NL-OMON24235
- Lead Sponsor
- department of rheumatologyLeids Universitair Medisch CentrumPostbus 9600 RC Leiden
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Inflammatory arthritis involving a knee (rheumatoid arthritis, juvenile chronic arthritis, spondylarthropathies and arthritis of unknown origin);br>
2. Age above 18;
Exclusion Criteria
1. Hemorrhagic disease;
2. Arthritis due to infection, gout or osteoarthritis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is recurrence or persistence of knee arthritis as defined by either:<br /><br>1. The need for local therapy such as joint aspiration or injection, arthroscopy or (radio-) synovectomy;<br /><br>2. Non-improvement of knee joint score.
- Secondary Outcome Measures
Name Time Method <b>Clinical parameters:</b><br /><br>1. The occurrence of (systemic) side effects;<br /><br>2. Physician’s assessment of local disease activity as measured by joint swelling as well as pain (see appendix 2);<br /><br>3. Patient’s functional status measured by a Health Assessment Questionnaire (HAQ);<br /><br>4. Patient’s Visual Analogue Scales (VAS) for local and general pain and overall disease activity;<br /><br>5. Physician’s assessment of overall disease activity (VAS);<br /><br>6. Disease Activity Score (DAS28);<br /><br>7. Morning stiffness;<br /><br>8. A five-point global assessment scale measuring improvement or deterioration compared to baseline and the previous assessment (see appendix 3).<br /><br><br><b>Laboratory parameters:</b><br /><br>9. ESR, CRP, and IgM rheumatoid factor titer;<br><br /><b><br>Radiological parameters:</b><br /><br>10. MRI quantification of the synovial tissue volume (blinded and at random order).