The efficacy and safety of intra-articular injections with the tumour-necrotising factor alpha (TNFa) antagonist infliximab in patients with chronic or recurrent arthritis of the knee

Completed

Conditions: Arthritis, spondyloarthropathy, rheumatoid arthritis
Musculoskeletal Diseases
Other rheumatoid arthritis

Registration Number: ISRCTN17726268

Lead Sponsor: eiden University Medical Centre (LUMC) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Inflammatory arthritis involving a knee (rheumatoid arthritis, juvenile chronic arthritis, spondylarthropathies and arthritis of unknown origin)
2. Aged above 18 years
3. Written informed consent
4. At least two therapeutic corticosteroid injections in the affected joint within a period of one year

Exclusion Criteria

1. Haemorrhagic 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 disease modifying anti-inflammatory drug (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 intravenous (iv) contrast
8. Active/latent tuberculosis
9. Acute/chronic infection
10. Multiple sclerosis
11. Decompensation cordis (New York Heart Association [NYHA] classification III and IV)
12. Pregnancy or lactating females
13. Malignancy
14. Claustrophobia
15. Pacemaker in situ/metal prostheses and/or vascular clips

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence or persistence of knee arthritis as defined by either:<br>1. The need for local therapy such as joint aspiration or injection, arthroscopy or (radio-) synovectomy<br>2. Non-improvement of knee joint score

Secondary Outcome Measures

Name	Time	Method
Clinical parameters:<br>1. The occurrence of (systemic) side effects<br>2. Physician's assessment of local disease activity as measured by joint swelling as well as pain<br>3. Patient's functional status measured by a Health Assessment Questionnaire (HAQ)<br>4. Patient's Visual Analogue Scales (VAS) for local and general pain and overall disease activity<br>5. Physician's assessment of overall disease activity (VAS)<br>6. Disease Activity Score (DAS28)<br>7. Morning stiffness<br>8. A five-point global assessment scale measuring improvement or deterioration compared to baseline and the previous assessment<br><br>Laboratory parameters:<br>Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and immunoglobulin M (IgM) rheumatoid factor titre<br><br>Radiological parameters:<br>Magnetic Resonance Imaging (MRI) quantification of the synovial tissue volume (blinded and at random order)