No registrations found.
ID
Source
Brief title
Health condition
Rheumatoid arthritis
Sponsors and support
Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
Intervention
Outcome measures
Primary outcome
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 outcome
To determine whether TNF targeted therapy with infliximab results in decreased synovial cellularity.
Background summary
To provide more insight into the mechanism of action of anti-TNF therapy in RA, we investigated whether early apoptosis induction is an important mechanism of action of infliximab therapy. This was studied in both peripheral blood and the inflamed knee joint before 1 or 24 hours after infusion in patients with active RA.
Study objective
Exploratory study to investigate the effects of TNF targeted therapy with infliximab on the synovial cell infiltrate, and the induction of apoptosis.
Study design
N/A
Intervention
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 knee joint. Peripheral blood mononuclear cells were obtained before and 1 and 24 hours after infliximab infusion in 20 patients (10 only blood, 10 with paired synovial biopsies). Serum was drawn at similar timepoints.
P.O. Box 22660
C.A. Wijbrandts
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
c.a.wijbrandts@amc.uva.nl
P.O. Box 22660
C.A. Wijbrandts
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
c.a.wijbrandts@amc.uva.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL983 |
| NTR-old | NTR1011 |
| Other | : |
| ISRCTN | ISRCTN20710193 |
Summary results
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