It is hypothesized that treatment with B cell directed therapy in the pre-clinical phase of RA will decrease the development of arthritis.
ID
Bron
Verkorte titel
Aandoening
pre-clinical RA
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To 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.
Achtergrond van het onderzoek
This 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.
Doel van het onderzoek
It is hypothesized that treatment with B cell directed therapy in the pre-clinical phase of RA will decrease the development of arthritis.
Onderzoeksopzet
Patients 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.
Onderzoeksproduct en/of interventie
All patients will receive B cell depleting therapy or placebo.
Publiek
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
Wetenschappelijk
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1857 |
| NTR-old | NTR1969 |
| Ander register | ABR nummer 27282 : MEC 09/048 # 09.17.1241 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |