A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab

niversity Hospital Gent0 sitesAugust 2, 2006

Overview

No summary available.

Registry

who.int

Start Date

August 2, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospital Gent

•Female/male \>, \= 18 years
•SSc according to the ARA criteria for systemic sclerosis
•Disease duration less than 4 years (from the appearance of skin changes (oedema, fibrosis)
•Inadequate response to methotrexate (at least 12 weeks 10 mg/w, except if not tolerated or contra\-indicated
•Antibodies specific for systemic sclerosis: anti\-topoisomerase; anti\-centromere antibodies
•Severe disease defined by either one of the following:
•o A modified Rodnan skin score (TSS° \>,\= 14 )
•o Disease activity score \>,\= 3
•Contraception for women with childbearing potential. Sexual abstinence is an alternative to contraception.
•Patient has signed informed consent.

•Disease duration more than 4 years
•FVC\<, \= 50%
•LVEF\<, \= 40% of predicted value,
•DLCO\<, \= 40% of predicted value
•Exclusion criteria as specifically described in the protocol for anti\-CD\-20:
•\- Lack of peripheral venous access.
•\- Pregnancy or breast feeding.
•\- Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
•\- Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator’s opinion, would preclude patient participation.
•\- Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.