An open label extension to the RHB-104-01 Study.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks
Number of Patients in Remission at Week 16
The number of patients who achieved a reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150 points. Lower CDAI scores indicate a better outcome.
Time frame: Week 16
Response at Week 16
Reduction of the total Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points Lower CDAI scores indicate a better outcome.
Time frame: Week 16
The Number of Weeks for Patients to Achieve Remission
\[Date of first observed remission (CDAI less than 150) - date of first dose, or date of randomization if not dosed, plus 1\] / 7 days. Subject who never experience remission during the study are censored at the time of their last CDAI assessment.
Time frame: Baseline through week 52
Number of Weeks the Patients Are in Remission
Duration of remission is defined as the number of weeks the subject is in remission (CDAI score \< 150). It is calculated as the first date following remission at which CDAI is ≥150 minus the date of first remission, plus 1 day, divided by 7. Subjects who experienced remission and continued to be in remission at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.
Time frame: Baseline through week 52
Number of Weeks to Achieve Response
\[Date of first observed response (a reduction from baseline of ≥ 100 in CDAI score) - Date of first dose or date of randomization if not dosed + 1\] / 7 Days. Subjects who never experienced response during the study are censored at the date of their last CDAI assessment.
Time frame: Baseline through week 52
Number of Weeks the Patients Are in Response.
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Digestive Care Associates, Inc., 1000 Laurel Street
San Carlos, California, United States
Gastrointestinal Specialists of Georgia PC 711 Canton Rd. #300
Marietta, Georgia, United States
Cotton-O'Neil Clinical Research Center, 720 SW Lane St.
Topeka, Kansas, United States
Chevy Chase Clinical Research, 5550 Friendship Blvd.
Chevy Chase, Maryland, United States
Commonwealth Clinical Studies, 189 Quincy St.
Brockton, Massachusetts, United States
ClinSearch 6035 Shallowford Road Suite 109
Chattanooga, Tennessee, United States
Discovery Clinical Services Ltd., 601 A Discovery St.
Victoria, British Columbia, Canada
Gastroenterologie s.r.o. Manesova 646
Hradec Králové, Czechia
Hepato-Gastroenterologie HK, s.r.o., Hradecka poliklinika III Trida Edvarda Benese 1549/34
Hradec Králové, Czechia
Ha'Emek Medical Center, Institute of Gastroenterology and Liver diseases, 21 Yitshak Rabin Boulevard
Afula, Israel
...and 14 more locations
Duration of response is defined as the number of weeks the subject is in a state of response (a reduction from baseline of ≥ 100 in CDAI score). It is calculated as the first date following response at which the reduction from baseline in CDAI is \<100 minus the date of first response, plus 1 day, divided by 7. Subjects who experienced response and continued to be in response at the time of their last CDAI assessment are censored at the date of their last CDAI assessment.
Time frame: Baseline through week 52
Durable Remission Week 16 Through Week 52
When a subject is in remission with a maximum CDAI score of 149 at every visit from week 16 through and including week 52.
Time frame: Week 16 through week 52