search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Hypothesis generating study to identify the changes in synovial tissue early after initiation of infliximab therapy


- candidate number2650
- NTR NumberNTR1011
- ISRCTNISRCTN20710193
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR2-jul-2007
- Secondary IDs 
- Public TitleHypothesis generating study to identify the changes in synovial tissue early after initiation of infliximab therapy
- Scientific TitleHypothesis generating study to identify the changes in synovial tissue early after initiation of infliximab therapy
- ACRONYMN/A
- hypothesisExploratory study to investigate the effects of TNF targeted therapy with infliximab on the synovial cell infiltrate, and the induction of apoptosis.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. 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 criteria1. 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, ReiterˇŻs 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 ˇăC), 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2003
- planned closingdate1-sep-2006
- Target number of participants20
- InterventionsInfliximab 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.
- Primary outcome1. 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 outcomeTo determine whether TNF targeted therapy with infliximab results in decreased synovial cellularity.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES C.A. Wijbrandts
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- Funding
(Source(s) of Monetary or Material Support)
Centocor BV Leiden
- PublicationsManuscripts in progress.

- Brief summaryTo 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.
- Main changes (audit trail)
- RECORD2-jul-2007 - 27-okt-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl