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Prevention of RA by B cell directed therapy.


- candidate number6354
- NTR NumberNTR1969
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-aug-2009
- Secondary IDsMEC 09/048 # 09.17.1241 ABR nummer 27282
- Public TitlePrevention of RA by B cell directed therapy.
- Scientific TitlePrevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.
- ACRONYMPRAIRI
- hypothesisIt is hypothesized that treatment with B cell directed therapy in the pre-clinical phase of RA will decrease the development of arthritis.
- Healt Condition(s) or Problem(s) studiedPre-clinical Rheumatoid arthritis
- Inclusion criteriaPatients with pre-clinical RA, defined by the presence of arthralgia and at least one of the following features:
1. IgM-rheumatoid factor (IgM-RF) of > 12.5 IU/ml;
2. Anti-citrullinated peptide antibodies (ACPA) in the serum of > 25 IU/ml;
3. At least one of the following features:
A. CRP > 3 mg/l;
B. ESR > 28 mm/h;
C. Subclinical synovitis as assessed by ultrasound;
D. Subclinical synovitis as assessed by MRI.
- Exclusion criteria1. Clinically evident arthritis;
2. History of arthritis;
3. Use of DMARDs;
4. Previous treatment with any cell depleting therapies;
5. Known active infection;
6. immunodeficiency;
7. Pregnant women.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-jan-2009
- planned closingdate11-jan-2013
- Target number of participants90
- InterventionsAll patients will receive B cell depleting therapy or placebo.
- Primary outcomeTo study if B cell depleting therapy delays/prevents the development of arthritis in patients with preclinical RA. The primary outcome measure is defined by the time to occurence of clinical arthritis.
- Secondary outcome1. To determine if prevention of RA by B cell depleting therapy is cost-effective and safe;
2. To study the effect of B cell depleting therapy in patients with pre-clinical RA;
3. To explore the pharmacodynamics of B cell therapy in this patient.
- TimepointsPatients will be followed for four years, with a study visite every four weeks up to week 16, every eight weeks up to week 36, and yearly until study completion. During each visit extensive standardized clinical assessments will be performed, consistent with standard clinical trial design in RA.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThis randomized, double blind, placebo-controlled prevention study is investigator driven and initiated by the Division of Clinical Immunology and Rheumatology at the Academic Medical Center (AMC), University of Amsterdam. The study will be performed in cooperation with the Maastricht University Medical Center (MUMC), Maastricht and the University Medical Center Groningen (UMCG), Groningen, and Rijnstate Hospital, Arnhem. Ninety people will be randomized to B cell depleting therapy and placebo. The patients will be followed for four years. If arthritis becomes manifest, patients will receive appropiate therapy chosen by their rheumatologist.
- Main changes (audit trail)
- RECORD28-aug-2009 - 12-okt-2009


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