Clinical Trial: A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy
Brief 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.
Detailed Summary:
Sponsor: University Hospital, Ghent
Current Primary Outcome: 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. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Testing the efficacy of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders. [ Time Frame: Efficacy will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60. ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Ghent
Dates:
Date Received: July 9, 2009
Date Started: June 2009
Date Completion: June 2016
Last Updated: February 6, 2014
Last Verified: February 2014