pre-clinical RA
Conditions
Interventions
All patients will receive B cell depleting therapy or placebo.
Sponsors
Academic Medical Center/University of Amsterdam, Amsterdam
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactP.P. Tak
Academic Medical Center (AMC), Department of Clinical Immunology and Rheumatology, P.O. Box 22660
Outcome results
None listed