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)
University of Saskatchewan Royal University Hospital, 103 Hospital Drive IBD Clinical Trials Unit Rm 2658
🇨🇦Saskatoon, Saskatchewan, Canada
Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny Żołnierska 18
🇵🇱Olsztyn, Poland
PIGEAS s.r.Prieložtek 1, o.,
🇸🇰Martin, Slovakia
Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330
🇺🇸Aventura, Florida, United States
Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300
🇺🇸Marietta, Georgia, United States
Mount Sinai Hospital, 600 University Avenue, Suite 445
🇨🇦Toronto, Ontario, Canada
The Carle Foundation, 611 West Park Street
🇺🇸Urbana, Illinois, United States
Department of Gastroenterology, Level 1, Clinic 123, New Clinical Building, Liverpool Hospital, Elizabeth St.
🇦🇺Liverpool, New South Wales, Australia
Digestive Disease Center, 621 Camden Street, Suite 202
🇺🇸San Antonio, Texas, United States
Ehrhardt Clinical Research, LLC, 108 Congress Street
🇺🇸Belton, Missouri, United States
Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303
🇺🇸Anaheim, California, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Advanced Research Institute Inc., 7114 Congress Street
🇺🇸New Port Richey, Florida, United States
Digestive Care Associates, Inc., 1000 Laurel St.
🇺🇸San Carlos, California, United States
Gastroenterology Group of Naples, 1064 Goodlette Road
🇺🇸Naples, Florida, United States
Ventura Clinical Trials, 1835 Knoll Drive
🇺🇸Ventura, California, United States
Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110
🇺🇸Port Orange, Florida, United States
Montefiore Medical Center, 111 East 210th Street
🇺🇸Bronx, New York, United States
Atlanta Center for Gastroenterology 2665 North Decatur Road Suite 550
🇺🇸Decatur, Georgia, United States
Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111
🇺🇸Lauderdale Lakes, Florida, United States
Commonwealth Clinical Studies, 189 Quincy St.
🇺🇸Brockton, Massachusetts, United States
AGA Clinical Research Associates, Inc., 3205 Fire Road
🇺🇸Egg Harbor Township, New Jersey, United States
MHAT "Sv. Karidad" EAD, Department of Internal Medicine / Gastroenterology, endocrinology and metabolic disorders, 23А, Nikola Vaptsarov Blvd
🇧🇬Plovdiv, Bulgaria
Tyler Research Institute, 1720 S. Beckham
🇺🇸Tyler, Texas, United States
NYU Langone Long Island , 1000 Northern Boulevard, Suite 160
🇺🇸Great Neck, New York, United States
Ohio GI and Liver Institute, 2925 Vernon Place 100
🇺🇸Cincinnati, Ohio, United States
Nemocnice Horovice, NH Hospital, a.s., Chirurgicke oddeleni, K Nemocnici 1106
🇨🇿Horovice, Czechia
ACIBADEM CITY CLINIC UNIVERSITY HOSPITAL EOOD, Oncology Center, Clinic of Gastroenterology, 66 A, Tsarigradsko shosse Blvd
🇧🇬Sofia, Bulgaria
McGuire DVAMC, 1201 Broad Rock Boulevard
🇺🇸Richmond, Virginia, United States
Department of Gastroenterology and Hepatology, Level 9, Ned Hanlon Building, Royal Brisbane and Women's Hospital Corner Butterfield Street and Bowen Bridge Street
🇦🇺Herston, Queensland, Australia
Discovery Clinical Services Ltd. 601 A Discovery St.
🇨🇦Victoria, British Columbia, Canada
DCC "Mladost-M Varna" OOD, office 528 V, 15, Republika Blvd.
🇧🇬Varna, Bulgaria
EGK s.r.o., Sanatorium sv. Anny, Gastroenterologicke oddeleni, Lucni 7a/2776,
🇨🇿Praha 3, Czechia
MHAT "Hadzhi Dimitar" OOD, Department of Internal Medicine / Gastroenterology and Endocrinology, 5, Dimitar Pehlivanov str.
🇧🇬Sliven, Bulgaria
Gasteroenterology Associates of Northern Virgina, 3028 Javier Road
🇺🇸Fairfax, Virginia, United States
Ohio GI and Liver Institute
🇺🇸Cincinnati, Ohio, United States
Assaf HaRofeh Medical Center, Gastroenterology Department, Harofeh Medical Center
🇮🇱Be'er Ya'aqov, Israel
Spring Gastroenterology Associates, 8901 FM 1960 West
🇺🇸Humble, Texas, United States
Department of Gastroenterology, Eastern Health, ECRU, Level 2, 5 Arnold Street
🇦🇺Box Hill, Victoria, Australia
Clinical Trials Unit, Tauranga Hospital,
🇳🇿Tauranga, New Zealand
Department of Gastroenterology,Waikato Hospital
🇳🇿Hamilton, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
RMC Beilinson Hospital, 39 Jabotinsky Street
🇮🇱Petach-Tikva, Israel
IBD centrum / ISCARE IVF a.s., Jankovcova 1569/2c
🇨🇿Praha, Czechia
Shaare Zedek Medical Center, Beith Street
🇮🇱Jerusalem, Israel
Ein Karem Medical Center, Kiryat Hadassah
🇮🇱Jerusalem, Israel
UMHAT "Sv. Ivan Rilski" EAD; Clinic of Gastroenterology, 15, Akad. Ivan Geshov Blvd.,
🇧🇬Sofia, Bulgaria
Bankstown Hospital, Level 3, Department of Gastroenterology, Eldridge Road
🇦🇺Bankstown, New South Wales, Australia
Ballarat Health Services, Drummond St North
🇦🇺Ballarat, Victoria, Australia
HEPATO-GASTROENTEROLOGIE HK, s.r.o., Trida Edvarda Benese 1549/34
🇨🇿Hradec Kralove, Czechia
Holy Family Hospital, Namsawi St. POB 8
🇮🇱Nazareth, Israel
Sourasky Medical Center, 6 Weizman Street
🇮🇱Tel Aviv, Israel
SP ZOZ MSWiA w Gdańsku, Oddział Gastroenterologiczny, ul. Kartuska 4/6
🇵🇱Gdańsk, Poland
Gastroenterology Unit, Southern District Health Board, 201 Great King Street,
🇳🇿Dunedin, New Zealand
ENDOSKOPIA sp. z o.o. B. Chrobrego 6/8
🇵🇱Sopot, Poland
"GASTROMED" Kopon, Zmudzinski i wspolnicy sp. j., Specjalistyczne Centrum Gastroskopii i Endoskopii, Specjalistyczne Gabinety Lekarskie Grudziadzka 11
🇵🇱Torun, Poland
Centrum Medyczne Szpital Sw. Rodziny Sp. z o.o. Wigury 19
🇵🇱Łódź, Poland
: Clinic for Gastroenterology and Hepatology, Clinical Center of Serbia Koste Todorovica 2
🇷🇸Belgrade, Serbia
Clinical Department of Gastroenterology and Hepatology, Clinic for Internal Diseases, Clinical Hospital Center Zvezdara Dimitrija Tucovica 161
🇷🇸Belgrade, Serbia
Department of Gastroenterology and Hepatology, Clinical Hospital Center Zemun Vukova 9
🇷🇸Belgrade, Serbia
: Center for Gastroenterohepatology, Clinic for Internal Medicine, Clinical Center of Kragujevac Zmaj Jovina 30
🇷🇸Kragujevac, Serbia
: Clinic of Gastroenterology and Hepatology, Clinical Center of Vojvodina Hajduk Veljkova 1
🇷🇸Novi Sad, Serbia
Univerzitná nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda Gastroenterologická klinika SZU a UNB Antolská 11
🇸🇰Bratislava, Slovakia
The E. Wolfson Medical Center, 62 Halohamim Str.
🇮🇱Holon, Israel
Galilee Medical Center, P.O.B. 21
🇮🇱Nahariya, Israel
Bnaizion Medical Center, Golomb 47
🇮🇱Haifa, Israel
ARTROSCAN, s.r.o., Gastroenterologicka ambulance, 5114 Trebovicka, Ostrava
🇨🇿Trebovice, Czechia
Department of Gastroenterology and Hepatology, Cabrini Medical Centre, 183 Wattletree Road
🇦🇺Malvern, Victoria, Australia
Department of Gastroenterology and Hepatology, Concord Hospital, Hospital Road
🇦🇺Concord, New South Wales, Australia
Nepean Hospital, Derby Street
🇦🇺Kingswood, New South Wales, Australia
Shakespeare Specialist Group, North Shore, Suite 3, 181 Shakespeare Road, Milford Takapuna
🇳🇿Auckland, New Zealand
North Shore Long Island Jewish Medical Group, 600 Northern Boulevard, Suite 111
🇺🇸Great Neck, New York, United States
Del Sol Research Management, 850 N Knob Road
🇺🇸Tucson, Arizona, United States
Medvin Clinical Research, 15627 Imperial Highway,
🇺🇸La Mirada, California, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Investigative Clinical Research, 612 Ridgely Avenue, Suite 401,
🇺🇸Annapolis, Maryland, United States
Chevy Chase Clinical Research, 5550 Friendship Blvd.
🇺🇸Chevy Chase, Maryland, United States
Manhattan Medical Research Practice PLLC, 215 Lexington Avenue, 21st Floor
🇺🇸New York, New York, United States
ClinSearch, 6035 Shallowford Road, Suite 109
🇺🇸Chattanooga, Tennessee, United States
Baylor College of Medicine, 7200 Cambridge Street Suite 180.184, 10th Floor
🇺🇸Houston, Texas, United States
Brooke Army Medical Center, 3551 Roger Brooke Drive
🇺🇸Fort Sam Houston, Texas, United States
DHAT Research Institute / Digestive Health Associates of Texas 3600 Shire Blvd, Suite 106
🇺🇸Richardson, Texas, United States
University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Medical School Bldg 4-234
🇺🇸Houston, Texas, United States
Mater Hospital Brisbane, Department of Gastroenterology, Raymond Terrace
🇦🇺South Brisbane, Queensland, Australia
Montreal General Hospital Digestive Lab Research Institute McGill University Health Center, 1650 Cedar Avenue C10.145
🇨🇦Montreal, Quebec, Canada
Gastroenterologie s.r.o., Manesova 646,
🇨🇿Hradec Kralove, Czechia
Krajska zdravotni, a.s., Masarykova nemocnice o.z. Gastroenterologie, Socialni pece 3316/12A
🇨🇿Usti nad Labem, Czechia
Meir, 59 Tchemacovsky St
🇮🇱Kfar-Saba, Israel
EuroMedis sp. z.o.o., ul. Powstanców Wielkopolskich 33a
🇵🇱Szczecin, Poland
NZOZ Specjalistyczne Centrum Gastrologii GASTROMED Wiejska 81
🇵🇱Bialystok, Poland
UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA Specjalistyczne Centrum Medyczne Sp. z o.o. Kluczborska 15
🇵🇱Krakow, Poland
ARS MEDICA s.c. Rybak Maria, Rybak Zbigniew, Powstancow Slaskich 56A/2
🇵🇱Wroclaw, Poland
Centralny Szpital Kliniczny MSW w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii Woloska 137
🇵🇱Warszawa, Poland
Univerzitna nemocnica Bratislava - Nemocnica Ružinov, V. Interná klinika LFUK a UNB, Gastroenterologické a hepatologické oddelenie, Ruzinovska 6
🇸🇰Bratislava, Slovakia
Breznianske centrum gastroenterologie, s.r.o. Banisko 1
🇸🇰Brezno, Slovakia
KM Management spol. s.r.o., Gastroenterologické a hepatologické centrum Nitra, Špitálska 13
🇸🇰Nitra, Slovakia
Cotton-O'Neil Clinical Research Center, 720 SW Lane St.
🇺🇸Topeka, Kansas, United States
Endoscopic Research, Inc., 1817 North Mills Avenue
🇺🇸Orlando, Florida, United States
University of North Carolina Center for inflammatory Bowel Diseases, CB 7080, 130 Mason Farm Road, 4151 Bioinformatics Bldg.
🇺🇸Chapel Hill, North Carolina, United States
Center For Digestive Health
🇺🇸Troy, Michigan, United States
Holy Name Medical Center, 718 Teaneck Road
🇺🇸Teaneck, New Jersey, United States
West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201
🇺🇸Wyoming, Michigan, United States