Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
- Registration Number
- NCT01951326
- Lead Sponsor
- RedHill Biopharma Limited
- Brief Summary
The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.
- Detailed Description
A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn's Disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 331
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RHB-104 RHB-104 5 RHB-104 capsules administered orally BID Placebo Placebo 5 placebo capsules administered orally BID
- Primary Outcome Measures
Name Time Method Remission at Week 26 Week 26 Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
- Secondary Outcome Measures
Name Time Method Response at Week 26 Week 26 Reduction of Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points. Lower CDAI scores indicate a better outcome.
Remission at Week 52 Week 52 Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Durable Remission Week 26 Through Week 52 Week 26 through week 52 When a subject is in remission with a maximum CDAI score of 149 at every visit from Week 26 through and including Week 52
Remission at Week 16 Week 16 Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Steroid Free Remission at Week 52 Week 52 Subjects who are maintained off steroids for a minimum of 3 weeks
Trial Locations
- Locations (103)
Del Sol Research Management, 850 N Knob Road
🇺🇸Tucson, Arizona, United States
Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303
🇺🇸Anaheim, California, United States
Medvin Clinical Research, 15627 Imperial Highway,
🇺🇸La Mirada, California, United States
Digestive Care Associates, Inc., 1000 Laurel St.
🇺🇸San Carlos, California, United States
Ventura Clinical Trials, 1835 Knoll Drive
🇺🇸Ventura, California, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330
🇺🇸Aventura, Florida, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111
🇺🇸Lauderdale Lakes, Florida, United States
Gastroenterology Group of Naples, 1064 Goodlette Road
🇺🇸Naples, Florida, United States
Scroll for more (93 remaining)Del Sol Research Management, 850 N Knob Road🇺🇸Tucson, Arizona, United States