A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy
- Sponsor
- University Hospital, Ghent
- Study ID
- NCT00936546
- Phase
- PHASE2
- Status
- Completed
Conditions
- Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGMabthera, Rituximab 1000 mg I.V.
Study Details
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.
Key Dates
- Start date
- Jun 30, 2009
- Status verified
- Jul 2021
- Primary completion
- Jun 3, 2015
- Completion
- Jun 3, 2015
Study Design
- Enrollment
- 3 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab
Primary Outcome Measure
Testing the safety of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders. [ Time Frame: Safety will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60. ]