Clinical Trial: A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Behcet's Syndrome
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Mucocutaneous Manifestations of Behcet's Syndrome
Brief Summary: Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's patients
Detailed Summary: This will be an open label study, where 20 Behcet's patients with resistant oral ulcers and 10 with resistant genital ulcers will be enrolled (screen 40). After enrollment all patients will be followed for a month to document the number of oral and genital ulcers on their current regimen. Then all patients will receive abatacept for 6 months (evaluated at weeks 0, 2, 4, 8, 12, 16 and 24). Then the treatment will be stopped and they will be observed for the next 2 months, for a total of 9 month trial.
Sponsor: New York University School of Medicine
Current Primary Outcome: ulcers [ Time Frame: 6 month treatment period ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Genital ulcers [ Time Frame: 6 month treatment ]Number of genital ulcers
- Treatment failures [ Time Frame: 6 months ]Number of patients who fail to complete 6 months (treatment failures)
- Oral ulcer pain [ Time Frame: 6 months ]Oral ulcer pain-Visual Analog Scale (VAS)
- Side Effects [ Time Frame: 6 months ]Monitoring of side effects
- MDHAQ [ Time Frame: 6 months ]Multidimensional health assessment questionnaire (MDHAQ)
- BSAS [ Time Frame: 6 months ]Behcet's syndrome activity score (BSAS)
- BDCAF [ Time Frame: 6 months ]Behcet's disease current activity form (BDCAF) scores
Original Secondary Outcome: Same as current
Information By: New York University School of Medicine
Dates:
Date Received: September 19, 2012
Date Started: June 2012
Date Completion: February 2018
Last Updated: January 23, 2017
Last Verified: January 2017