A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab… (NCT00936546) | Clinical Trial Compass
CompletedPhase 2
A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy
Belgium3 participantsStarted 2009-06
Plain-language summary
This study will evaluate the safety and efficacy of the combination of rituximab and methotrexate to treat disabling fibrosing skin disorders.Rituximab will be administered at baseline and month 6. The drug will be considered efficacious if the skin thickness diminishes substantially.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* (Fe) male \>, = 18 years
* Fibrosing skin disorder, not fulfilling the ACR criteria for diffuse SSc
* Inadequate response to methotrexate (at least 12 weeks 10 mg/w, except if not tolerated or contra-indicated
* Debilitating disease defined by either one of the following:
* Restriction of mobility
* Disfiguration: eg: facial involvement
* Severe Internal Organ involvement
* Contraception for women with childbearing potential. Sexual abstinence is an alternative to contraception.
Exclusion Criteria:
* 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.
* Known active infection of any kind (excluding fungal infections of mail beds), or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks prior to baseline.
* History of deep spa…
What they're measuring
1
Testing the safety of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders.
Timeframe: Safety will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60.