Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
NCT ID: NCT01951326
Last Updated: 2020-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2013-09-30
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RHB-104
5 RHB-104 capsules administered orally BID
RHB-104
95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
Placebo
5 placebo capsules administered orally BID
Placebo
5 placebo capsules administered orally BID
Interventions
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RHB-104
95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
Placebo
5 placebo capsules administered orally BID
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Crohn's Disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study.
3. CD involving the ileum and/or colon
4. Moderately to severely active CD (Crohn's Disease Activity Index (CDAI) score of greater than or equal to 220 and less than or equal to 450) at baseline.
5. Current treatment with at least one of the following therapies:
A. Oral 5-acetyl salicylic acid (5-ASA) compounds. Dose must be stable for at least 4 weeks before baseline.
B. Corticosteroid therapy. Dose must be stable for at least 2 weeks before baseline.
C. Azathioprine or 6-mercaptopurine (6-MP) or methotrexate. Dose must be stable for at least 8 weeks before baseline.
D. Infliximab or adalimumab. Dose must be stable for at least 14 weeks before baseline.
6. White blood cell count greater than or equal to 3.5 x 109 at screening.
7. Active Crohn's disease, defined by at least one of the following: C-reactive protein greater than Upper Limit of Normal (ULN) at screening, fecal calprotectin greater than Upper Limit of Normal (ULN) at screening, OR radiographic (MRE or CTE) or endoscopic confirmation of the presence of active CD within 5 weeks of screening visit. .
8. Subject agrees to use barrier contraceptive methods (i.e. diaphragm, cervical cap, contraceptive sponge or condom) with spermicidal foam/gel/cream/suppository, IUD/IUS or progestogen injection (Depo-Provera®) throughout the study and for at least 6 weeks after last study drug administration, unless subject is post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation, or has had a vasectomy. In regions where local regulatory contraceptive requirements differ, the ICF will reflect local policies.
Exclusion Criteria
2. History of total colectomy with ileorectal anastomosis or a proctocolectomy.
3. Presence of active fistulizing Crohn's Disease or healed fistula within 2 months prior to screening.
4. Subject has postoperative stoma, ostomy, or ileoanal pouch.
5. Subject has short bowel syndrome.
6. Subject is scheduled for surgical bowel resection.
7. Subject has known symptomatic obstructive strictures or bowel perforation in the 6 months prior to screening.
8. Change in dose or discontinuation of oral 5-acetyl salicylic acid (5-ASA) compounds less than 4 weeks prior to baseline.
9. Change in dose or discontinuation of corticosteroids less than 2 weeks prior to baseline.
10. Change in dose or discontinuation of azathioprine, 6-mercaptopurine (6-MP) or methotrexate less than 8 weeks prior to baseline.
11. Change in dose or discontinuation of infliximab or adalimumab less than 14 weeks prior to baseline.
12. Treatment with vedolizumab less than 120 days prior to baseline or biological therapies (apart from infliximab or adalimumab) less than 60 days prior to baseline.
13. Previous treatment with rifabutin and/or clofazimine.
14. Oral or parenteral antibiotics in the 4 weeks prior to baseline (topical antibiotics are permitted).
15. Treatment with probiotics (excluding yogurt and yogurt-derived products) in the 4 weeks prior to baseline.
16. Females who have a positive pregnancy test or are lactating.
18 Years
75 Years
ALL
No
Sponsors
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RedHill Biopharma Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Ira N Kalfus, MD
Role: STUDY_DIRECTOR
RedHill Biopharma
David Y. Graham, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
Locations
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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
Advanced Research Institute Inc., 7114 Congress Street
New Port Richey, Florida, United States
Endoscopic Research, Inc., 1817 North Mills Avenue
Orlando, Florida, United States
Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110
Port Orange, Florida, United States
Atlanta Center for Gastroenterology 2665 North Decatur Road Suite 550
Decatur, Georgia, United States
Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
The Carle Foundation, 611 West Park Street
Urbana, Illinois, United States
Cotton-O'Neil Clinical Research Center, 720 SW Lane St.
Topeka, Kansas, 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
Commonwealth Clinical Studies, 189 Quincy St.
Brockton, Massachusetts, United States
Center For Digestive Health
Troy, Michigan, United States
West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201
Wyoming, Michigan, United States
Ehrhardt Clinical Research, LLC, 108 Congress Street
Belton, Missouri, United States
AGA Clinical Research Associates, Inc., 3205 Fire Road
Egg Harbor, New Jersey, United States
Holy Name Medical Center, 718 Teaneck Road
Teaneck, New Jersey, United States
North Shore Long Island Jewish Medical Group, 600 Northern Boulevard, Suite 111
Great Neck, New York, United States
NYU Langone Long Island , 1000 Northern Boulevard, Suite 160
Great Neck, New York, United States
Manhattan Medical Research Practice PLLC, 215 Lexington Avenue, 21st Floor
New York, New York, United States
Montefiore Medical Center, 111 East 210th Street
The Bronx, New York, 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
Ohio GI and Liver Institute, 2925 Vernon Place 100
Cincinnati, Ohio, United States
Ohio GI and Liver Institute
Cincinnati, Ohio, United States
ClinSearch, 6035 Shallowford Road, Suite 109
Chattanooga, Tennessee, United States
Brooke Army Medical Center, 3551 Roger Brooke Drive
Fort Sam Houston, Texas, United States
Baylor College of Medicine, 7200 Cambridge Street Suite 180.184, 10th Floor
Houston, Texas, United States
University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Medical School Bldg 4-234
Houston, Texas, United States
Spring Gastroenterology Associates, 8901 FM 1960 West
Humble, Texas, United States
DHAT Research Institute / Digestive Health Associates of Texas 3600 Shire Blvd, Suite 106
Richardson, Texas, United States
Digestive Disease Center, 621 Camden Street, Suite 202
San Antonio, Texas, United States
Tyler Research Institute, 1720 S. Beckham
Tyler, Texas, United States
Gasteroenterology Associates of Northern Virgina, 3028 Javier Road
Fairfax, Virginia, United States
McGuire DVAMC, 1201 Broad Rock Boulevard
Richmond, Virginia, United States
Bankstown Hospital, Level 3, Department of Gastroenterology, Eldridge Road
Bankstown, New South Wales, Australia
Department of Gastroenterology and Hepatology, Concord Hospital, Hospital Road
Concord, New South Wales, Australia
Nepean Hospital, Derby Street
Kingswood, New South Wales, Australia
Department of Gastroenterology, Level 1, Clinic 123, New Clinical Building, Liverpool Hospital, Elizabeth St.
Liverpool, New South Wales, Australia
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
Mater Hospital Brisbane, Department of Gastroenterology, Raymond Terrace
South Brisbane, Queensland, Australia
Ballarat Health Services, Drummond St North
Ballarat, Victoria, Australia
Department of Gastroenterology, Eastern Health, ECRU, Level 2, 5 Arnold Street
Box Hill, Victoria, Australia
Department of Gastroenterology and Hepatology, Cabrini Medical Centre, 183 Wattletree Road
Malvern, Victoria, Australia
MHAT "Sv. Karidad" EAD, Department of Internal Medicine / Gastroenterology, endocrinology and metabolic disorders, 23А, Nikola Vaptsarov Blvd
Plovdiv, , Bulgaria
MHAT "Hadzhi Dimitar" OOD, Department of Internal Medicine / Gastroenterology and Endocrinology, 5, Dimitar Pehlivanov str.
Sliven, , Bulgaria
UMHAT "Sv. Ivan Rilski" EAD; Clinic of Gastroenterology, 15, Akad. Ivan Geshov Blvd.,
Sofia, , Bulgaria
ACIBADEM CITY CLINIC UNIVERSITY HOSPITAL EOOD, Oncology Center, Clinic of Gastroenterology, 66 A, Tsarigradsko shosse Blvd
Sofia, , Bulgaria
DCC "Mladost-M Varna" OOD, office 528 V, 15, Republika Blvd.
Varna, , Bulgaria
Discovery Clinical Services Ltd. 601 A Discovery St.
Victoria, British Columbia, Canada
Mount Sinai Hospital, 600 University Avenue, Suite 445
Toronto, Ontario, Canada
Montreal General Hospital Digestive Lab Research Institute McGill University Health Center, 1650 Cedar Avenue C10.145
Montreal, Quebec, Canada
University of Saskatchewan Royal University Hospital, 103 Hospital Drive IBD Clinical Trials Unit Rm 2658
Saskatoon, Saskatchewan, Canada
Nemocnice Horovice, NH Hospital, a.s., Chirurgicke oddeleni, K Nemocnici 1106
Hořovice, , Czechia
Gastroenterologie s.r.o., Manesova 646,
Hradec Králové, , Czechia
HEPATO-GASTROENTEROLOGIE HK, s.r.o., Trida Edvarda Benese 1549/34
Hradec Králové, , Czechia
EGK s.r.o., Sanatorium sv. Anny, Gastroenterologicke oddeleni, Lucni 7a/2776,
Prague, , Czechia
IBD centrum / ISCARE IVF a.s., Jankovcova 1569/2c
Prague, , Czechia
ARTROSCAN, s.r.o., Gastroenterologicka ambulance, 5114 Trebovicka, Ostrava
Třebovice, , Czechia
Krajska zdravotni, a.s., Masarykova nemocnice o.z. Gastroenterologie, Socialni pece 3316/12A
Ústí nad Labem, , Czechia
Assaf HaRofeh Medical Center, Gastroenterology Department, Harofeh Medical Center
Be’er Ya‘aqov, , Israel
Bnaizion Medical Center, Golomb 47
Haifa, , Israel
The E. Wolfson Medical Center, 62 Halohamim Str.
Holon, , Israel
Shaare Zedek Medical Center, Beith Street
Jerusalem, , Israel
Ein Karem Medical Center, Kiryat Hadassah
Jerusalem, , Israel
Meir, 59 Tchemacovsky St
Kfar Saba, , Israel
Galilee Medical Center, P.O.B. 21
Nahariya, , Israel
Holy Family Hospital, Namsawi St. POB 8
Nazareth, , Israel
RMC Beilinson Hospital, 39 Jabotinsky Street
Petah Tikva, , Israel
Sourasky Medical Center, 6 Weizman Street
Tel Aviv, , Israel
Shakespeare Specialist Group, North Shore, Suite 3, 181 Shakespeare Road, Milford Takapuna
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Gastroenterology Unit, Southern District Health Board, 201 Great King Street,
Dunedin, , New Zealand
Department of Gastroenterology,Waikato Hospital
Hamilton, , New Zealand
Clinical Trials Unit, Tauranga Hospital,
Tauranga, , New Zealand
NZOZ Specjalistyczne Centrum Gastrologii GASTROMED Wiejska 81
Bialystok, , Poland
SP ZOZ MSWiA w Gdańsku, Oddział Gastroenterologiczny, ul. Kartuska 4/6
Gdansk, , Poland
UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA Specjalistyczne Centrum Medyczne Sp. z o.o. Kluczborska 15
Krakow, , Poland
Centrum Medyczne Szpital Sw. Rodziny Sp. z o.o. Wigury 19
Lodz, , Poland
Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny Żołnierska 18
Olsztyn, , Poland
ENDOSKOPIA sp. z o.o. B. Chrobrego 6/8
Sopot, , Poland
EuroMedis sp. z.o.o., ul. Powstanców Wielkopolskich 33a
Szczecin, , Poland
"GASTROMED" Kopon, Zmudzinski i wspolnicy sp. j., Specjalistyczne Centrum Gastroskopii i Endoskopii, Specjalistyczne Gabinety Lekarskie Grudziadzka 11
Torun, , Poland
Centralny Szpital Kliniczny MSW w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii Woloska 137
Warsaw, , Poland
ARS MEDICA s.c. Rybak Maria, Rybak Zbigniew, Powstancow Slaskich 56A/2
Wroclaw, , 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
Univerzitna nemocnica Bratislava - Nemocnica Ružinov, V. Interná klinika LFUK a UNB, Gastroenterologické a hepatologické oddelenie, Ruzinovska 6
Bratislava, , Slovakia
Univerzitná nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda Gastroenterologická klinika SZU a UNB Antolská 11
Bratislava, , Slovakia
Breznianske centrum gastroenterologie, s.r.o. Banisko 1
Brezno, , Slovakia
PIGEAS s.r.Prieložtek 1, o.,
Martin, , Slovakia
KM Management spol. s.r.o., Gastroenterologické a hepatologické centrum Nitra, Špitálska 13
Nitra, , Slovakia
Countries
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References
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Graham DY, Naser SA, Borody T, Hebzda Z, Sarles H, Levenson S, Hardi R, Arlukowicz T, Svorcan P, Fathi R, Bibliowicz A, Anderson P, McLean P, Fehrmann C, Harris MS, Zhao S, Kalfus IN. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Related Info
Other Identifiers
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RHB-104-01
Identifier Type: -
Identifier Source: org_study_id