No registrations found.
ID
Source
Brief title
Health condition
pre-clinical RA
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
1. 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.
Background summary
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.
Study objective
It is hypothesized that treatment with B cell directed therapy in the pre-clinical phase of RA will decrease the development of arthritis.
Study design
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.
Intervention
All patients will receive B cell depleting therapy or placebo.
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
Inclusion criteria
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.
Exclusion criteria
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.
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 | NL1857 |
| NTR-old | NTR1969 |
| Other | ABR nummer 27282 : MEC 09/048 # 09.17.1241 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |