Clinical Trial: Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study

Brief Summary: An open label extension to the RHB-104-01 Study.

Detailed Summary: An Open Label Phase III Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study.
Sponsor: RedHill Biopharma Limited

Current Primary Outcome: Remission [ Time Frame: 16 weeks ]

Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to remission [ Time Frame: Baseline through week 52 ]
    The time (weeks after randomization) that a subject first records a state of remission.
  • Duration of remission [ Time Frame: Baseline through week 52 ]
    The time that a subject is in a state of remission.
  • Maintenance of Remission [ Time Frame: Baseline through week 52 ]
    Remission in a subject from week 16 through week 52.
  • Duration of response [ Time Frame: Baseline through week 52 ]
    The time that a subject is in a state of response.
  • Time to response [ Time Frame: Baseline through week 52 ]
    The time (weeks after randomization) that a subject first records a state of response.


Original Secondary Outcome: Same as current

Information By: RedHill Biopharma Limited

Dates:
Date Received: December 26, 2016
Date Started: March 18, 2017
Date Completion: October 2019
Last Updated: May 9, 2017
Last Verified: December 2016