Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus (FumaCLE)
The purpose of this study is to evaluate the therapeutic effect of fumaric acid esters (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Mono-Centre, Open-Label, Prospective Pilot Study|
- Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely. [ Time Frame: Week 24 or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF). ] [ Designated as safety issue: No ]Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50").
- Proportion of patients with RCLASI 50 at week 12 of treatment [ Time Frame: Week 12 of treatment ] [ Designated as safety issue: No ]
- Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions) [ Time Frame: End of therapy (up to 24 weeks) ] [ Designated as safety issue: No ]
- Time from start of treatment to first RCLASI 50 assessment (time to response). [ Time Frame: Time to response (up to 24 weeks) ] [ Designated as safety issue: No ]
- Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment and at the end of therapy. [ Time Frame: 12 weeks after the beginning of treatment and at the end of therapy (up to 24 weeks). ] [ Designated as safety issue: No ]
- Number of Participants with Adverse Events (AEs) and their severity. [ Time Frame: 24 weeks of treatment + 4 weeks of follow up ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Experimental: Fumaric acid esters||
Drug: Fumaric acid esters
Starting from 1 tablet Fumaderm® initial per day, with titration up to 6 tablets Fumaderm® per day; in case of side effects, the dose will be adapted to the highest tolerable levels
At screening, patients meeting the inclusion and exclusion criteria will be asked to provide written informed consent. Male patients and female patients without childbearing potential will also complete other screening procedures including vital signs, physical examination, and patients and physicians efficacy assessments.
Treatment will be started as soon as possible after screening and not later than 1 month after screening.
The patients will receive a treatment either with Fumaderm® initial and/or Fumaderm® enteric-coated tablets. Fumaderm® initial will be usually administered during the first three weeks of treatment and / or during the trial when adaptation of the daily dosage will be required due to the occurrence of adverse reactions, e.g gastrointestinal.
Throughout the trial, daily use of sunscreens (sun protection factor, SPF≥50) will be recommended to all patients. The management of CLE may also involve the use of topical medications, such as topical steroids, or systemic rescue medications, such as antimalarials.
All patients will be evaluated with the RCLASI, PAGI and VAS after 12 weeks and at the end of treatment. Adverse Events (AE) will be recorded at each visit until 4 weeks after the end of therapy. Serious Adverse Events (SAE) must be reported if they occur up to 4 weeks after the end of therapy.
|Contact: Annegret Kuhn, Prof. Dr.||firstname.lastname@example.org|
|Department of Dermatology, University Hospital Muenster||Recruiting|
|Muenster, Germany, 48149|
|Contact: Annegret Kuhn, Prof. Dr. email@example.com|
|Principal Investigator: Annegret Kuhn, Prof. Dr.|
|Sub-Investigator: Nikolaos Patsinakidis|
|Principal Investigator:||Annegret Kuhn, Prof. Dr.||Department of Dermatology, University Hospital Muenster|