Rheumatoid arthritis
Conditions
Interventions
Infliximab therapy (3mg/kg i.v.) according to the normal regimen. At baseline and 1 (n=5) hour or 24 hours (n=5) after the first infliximab infusion synovial biopsies were obtained from an inflamed k
Sponsors
Principal investigator: Prof. Dr. P.P. Tak
Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
Eligibility
Inclusion criteria
Inclusion criteria: 1. RA patients with active disease at baseline assessed by the DAS28; 2. Be =>18 years of age; 3. Use concurrent methotrexate treatment (7.5-30 mg/week; stable since =>28 days before initiation) during the study. Subjects may be taking nonsteroidal anti-inflammatory drugs, provided the dose and frequency have been stable for at least 28 days. Subjects may be receiving prednisone therapy <=10 mg/day provided that the dosage has been stable for at least a months prior to entry.
Exclusion criteria
Exclusion criteria: 1. Pregnancy; 2. Breastfeeding; 3. A history of or acute inflammatory joint disease of different origin e.g. mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter¡¯s syndrome, systemic lupus erythematosus or any arthritis with onset prior to age 16 years; 4. Acute major trauma; 5. Previous therapy at any time with: a. TNF-directed monoclonal antibodies p75 TNF receptor fusion protein; 6. Therapy within the previous 45 days with: a. any experimental drug; b. alkylating agents, e.g. cyclophosphamide, chlorambucil; c. anti metabolites; d. monoclonal antibodies; e. growth factors; f. other cytokines; 7. Therapy within the previous 28 days with: a. parenteral or intraarticular corticoid injections; b. oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily; c. present use of DMARDs other than methotrexate; 8. Fever (orally measured > 38 ¡ãC), chronic infections or infections requiring anti-microbial therapy; 9. Manifest cardiac failure (stage III or IV according to NYHA classification); 10. Progressive fatal disease/terminal illness; 11. A hematopoietic disease; 12. Body weight of less than 45 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary immunohistologic outcome: detection of apoptosis in synovial tissue within 1 or 24 hours after initiation of treatment. Analysis by immunohistochemical staining and electronmicroscopy. 2. Primairy serological outcome: To determine whether TNF targeted therapy with infliximab results in apoptosis of peripheral blood mononuclear cells within 1 or 24 hours after initiation of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether TNF targeted therapy with infliximab results in decreased synovial cellularity. | — |
Contacts
Public ContactC.A. Wijbrandts
Academic Medical Center (AMC), Department of Medicine, Division of Clinical Immunology and Rheumatology, F4-218, P.O. Box 22660
Outcome results
None listed