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 ]

The primary endpoint is number of oral and genital ulcers (AUC) during the 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