Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.

Division of Clinically Immunology and Rheumatology, AMC0 sitesFebruary 27, 2009

Overview

No summary available.

Registry

who.int

Start Date

February 27, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Division of Clinically Immunology and Rheumatology, AMC

•\- Patients with pre\-clinical RA, defined by the presence of arthralgia and at least one of the following features:
•¦ IgM\-rheumatoid factor (IgM\-RF) of \> 12\.5 IU/ml
•¦anti\-citrullinated peptide antibodies (ACPA) in the serum of \> 25 IU/ml
•and at least one of the following features:
•¦CRP \> 3 mg/l
•¦ESR \> 28 mm/h
•¦Subclinical synovitis as assessed by ultrasound
•¦Subclinical synovitis as assessed by MRI
•\- Age 18\-80 years
•\- Patients of reproductive potential (males and females) must use a reliable means of contraception (e.g. contraceptive pill, IUD, physical barrier) until one year after the last infusion of rituximab or the entire duration that the patient is B\-cell depleted, whichever is longer.

•\- Clinically evident arthritis, as assessed by a rheumatologist and/or a research physician.
•\- History of arthritis, as assessed by a rheumatologist.
•\- History or current use of DMARDs or biologicals
•\- Previous treatment with any cell depleting therapies, including investigational agents (e.g. CAMPATH, anti\-CD4, anti\-CD5, anti\-CD3, anti\-CD19\)
•\- Presence of any disease for which patient needs chronic or intermittent immunosuppressive therapy (e.g. prednisolon for COPD)
•\- Previous treatment within 6 months with intravenous gamma globulin
•\- History of (oral or) parenteral corticosteroid use within 4 weeks prior to inclusion
•\- Receipt of a live vaccine within 4 weeks prior to randomization
•\- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
•\- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)