recurrent or persistent inflammatory arthritis involving a knee (rheumatoid arthritis, juvenile chronic arthritis, spondylarthropathies and arthritis of unknown origin) despite corticosteroid injections intra-articular
Conditions
Interventions
Treatment with infliximab 100mg intra-articular or methylprednisolon 80mg intra-articular.
Sponsors
department of rheumatology
Leids Universitair Medisch Centrum
Postbus 9600 RC Leiden
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inflammatory arthritis involving a knee (rheumatoid arthritis, juvenile chronic arthritis, spondylarthropathies and arthritis of unknown origin);br> 2. Age above 18; 3. Written informed consent; 4. At least two therapeutic corticosteroid injections in the affected joint within a period of one year.
Exclusion criteria
Exclusion criteria: 1. Hemorrhagic disease; 2. Arthritis due to infection, gout or osteoarthritis; 3. Participation in any other study which interferes with or is influenced by this study; 4. Use of oral prednisone in excess of 10 mg/day; 5. Recent change of DMARD-therapy (six weeks or less); 6. Intra-articular injection with corticosteroid less than two months ago (concerning all joints); 7. Hypersensitivity to methylprednisolone/triamcinolone, lidocain or infliximab (murine proteins) or i.v. contrast; 8. Active/ latent tuberculosis; 9. Acute/ chronic infection; 10. Multiple sclerosis; 11. Decompensatio cordis (NYHA classification III and IV); 12. Pregnancy or lactating females; 13. Malignancy; 14. Claustrophobia; 15. Pacemaker in situ / metal prostheses and/or vascular clips.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is recurrence or persistence of knee arthritis as defined by either: 1. The need for local therapy such as joint aspiration or injection, arthroscopy or (radio-) synovectomy; 2. Non-improvement of knee joint score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical parameters: 1. The occurrence of (systemic) side effects; 2. Physician’s assessment of local disease activity as measured by joint swelling as well as pain (see appendix 2); 3. Patient’s functional status measured by a Health Assessment Questionnaire (HAQ); 4. Patient’s Visual Analogue Scales (VAS) for local and general pain and overall disease activity; 5. Physician’s assessment of overall disease activity (VAS); 6. Disease Activity Score (DAS28); 7. Morning stiffness; 8. A five-point global assessment scale measuring improvement or deterioration compared to baseline and the previous assessment (see appendix 3). Laboratory parameters: 9. ESR, CRP, and IgM rheumatoid factor titer; Radiological parameters: 10. MRI quantification of the synovial tissue volume (blinded and at random order). | — |
Contacts
Public ContactA.E. Bijl, van der
Leiden University Medical Center (LUMC), Department of Rheumatology, P.O. Box 9600
Outcome results
None listed