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Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease (MAPUS)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RHB-104
Placebo
Sponsored by
RedHill Biopharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, moderate to severe, remission, MAP, antibiotic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Signed fully informed consent provided as per this protocol.
  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

  1. Crohn's Disease involvement isolated to the mouth, upper gastrointestinal tract, or anus.
  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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RHB-104

Placebo

Arm Description

5 RHB-104 capsules administered orally BID

5 placebo capsules administered orally BID

Outcomes

Primary Outcome Measures

Remission at 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

Response at 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
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
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
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
Subjects who are maintained off steroids for a minimum of 3 weeks

Full Information

First Posted
September 19, 2013
Last Updated
November 29, 2020
Sponsor
RedHill Biopharma Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01951326
Brief Title
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
Acronym
MAPUS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RedHill Biopharma Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, moderate to severe, remission, MAP, antibiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RHB-104
Arm Type
Active Comparator
Arm Description
5 RHB-104 capsules administered orally BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5 placebo capsules administered orally BID
Intervention Type
Drug
Intervention Name(s)
RHB-104
Intervention Description
95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5 placebo capsules administered orally BID
Primary Outcome Measure Information:
Title
Remission at Week 26
Description
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Response at Week 26
Description
Reduction of Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points. Lower CDAI scores indicate a better outcome.
Time Frame
Week 26
Title
Remission at Week 52
Description
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Time Frame
Week 52
Title
Durable Remission Week 26 Through Week 52
Description
When a subject is in remission with a maximum CDAI score of 149 at every visit from Week 26 through and including Week 52
Time Frame
Week 26 through week 52
Title
Remission at Week 16
Description
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
Time Frame
Week 16
Title
Steroid Free Remission at Week 52
Description
Subjects who are maintained off steroids for a minimum of 3 weeks
Time Frame
Week 52
Other Pre-specified Outcome Measures:
Title
Duration of Remission
Description
Number of weeks that a subject is in a state of remission. 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
Title
Duration of Response
Description
Number of weeks a subject is in a state of response. 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
Title
Time to Remission
Description
[Date of first observed remission (CDAI score < 150) - Date of first dose or date of randomization if not dosed + 1] / 7 Days. Subjects who never experienced remission during the study are censored at the date of their last CDAI assessment.
Time Frame
Baseline through week 52
Title
Time to Response
Description
[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
Title
Durable Remission Week 16 Through Week 52
Description
Remission in a subject from week 16 through week 52.
Time Frame
Week 16 through week 52
Title
Response at Week 16
Description
Reduction of Crohn's Disease Activity Index (CDAI) score by a minimum of 100 points. Lower CDAI scores indicate a better outcome.
Time Frame
Week 16
Title
Cardiac Safety
Description
Change-from-baseline to week 26 in QTcF (based on cardiac safety report)
Time Frame
Week 26
Title
Cardiac Safety
Description
Placebo-corrected change-from-baseline to week 52 in QTcF (based on cardiac safety report)
Time Frame
Baseline through week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Signed fully informed consent provided as per this protocol. Diagnosis of Crohn's Disease confirmed by endoscopy or radiography and/or histology at least 6 months prior to randomization into the study. CD involving the ileum and/or colon 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. 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. White blood cell count greater than or equal to 3.5 x 109 at screening. 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. . 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 Crohn's Disease involvement isolated to the mouth, upper gastrointestinal tract, or anus. History of total colectomy with ileorectal anastomosis or a proctocolectomy. Presence of active fistulizing Crohn's Disease or healed fistula within 2 months prior to screening. Subject has postoperative stoma, ostomy, or ileoanal pouch. Subject has short bowel syndrome. Subject is scheduled for surgical bowel resection. Subject has known symptomatic obstructive strictures or bowel perforation in the 6 months prior to screening. Change in dose or discontinuation of oral 5-acetyl salicylic acid (5-ASA) compounds less than 4 weeks prior to baseline. Change in dose or discontinuation of corticosteroids less than 2 weeks prior to baseline. Change in dose or discontinuation of azathioprine, 6-mercaptopurine (6-MP) or methotrexate less than 8 weeks prior to baseline. Change in dose or discontinuation of infliximab or adalimumab less than 14 weeks prior to baseline. 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. Previous treatment with rifabutin and/or clofazimine. Oral or parenteral antibiotics in the 4 weeks prior to baseline (topical antibiotics are permitted). Treatment with probiotics (excluding yogurt and yogurt-derived products) in the 4 weeks prior to baseline. Females who have a positive pregnancy test or are lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira N Kalfus, MD
Organizational Affiliation
RedHill Biopharma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Y. Graham, MD
Organizational Affiliation
Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Del Sol Research Management, 850 N Knob Road
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Medvin Clinical Research, 15627 Imperial Highway,
City
La Mirada
State/Province
California
ZIP/Postal Code
90638
Country
United States
Facility Name
Digestive Care Associates, Inc., 1000 Laurel St.
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
Ventura Clinical Trials, 1835 Knoll Drive
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Gastroenterology Group of Naples, 1064 Goodlette Road
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advanced Research Institute Inc., 7114 Congress Street
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Endoscopic Research, Inc., 1817 North Mills Avenue
City
Orlando
State/Province
Florida
ZIP/Postal Code
32802
Country
United States
Facility Name
Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Atlanta Center for Gastroenterology 2665 North Decatur Road Suite 550
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The Carle Foundation, 611 West Park Street
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, 720 SW Lane St.
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Investigative Clinical Research, 612 Ridgely Avenue, Suite 401,
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Chevy Chase Clinical Research, 5550 Friendship Blvd.
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Commonwealth Clinical Studies, 189 Quincy St.
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302-2926
Country
United States
Facility Name
Center For Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Ehrhardt Clinical Research, LLC, 108 Congress Street
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
Country
United States
Facility Name
AGA Clinical Research Associates, Inc., 3205 Fire Road
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08324
Country
United States
Facility Name
Holy Name Medical Center, 718 Teaneck Road
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Montefiore Medical Center, 111 East 210th Street
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
North Shore Long Island Jewish Medical Group, 600 Northern Boulevard, Suite 111
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Langone Long Island , 1000 Northern Boulevard, Suite 160
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Manhattan Medical Research Practice PLLC, 215 Lexington Avenue, 21st Floor
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of North Carolina Center for inflammatory Bowel Diseases, CB 7080, 130 Mason Farm Road, 4151 Bioinformatics Bldg.
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio GI and Liver Institute, 2925 Vernon Place 100
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio GI and Liver Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
ClinSearch, 6035 Shallowford Road, Suite 109
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Brooke Army Medical Center, 3551 Roger Brooke Drive
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Baylor College of Medicine, 7200 Cambridge Street Suite 180.184, 10th Floor
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Medical School Bldg 4-234
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Spring Gastroenterology Associates, 8901 FM 1960 West
City
Humble
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
DHAT Research Institute / Digestive Health Associates of Texas 3600 Shire Blvd, Suite 106
City
Richardson
State/Province
Texas
ZIP/Postal Code
75082
Country
United States
Facility Name
Digestive Disease Center, 621 Camden Street, Suite 202
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Tyler Research Institute, 1720 S. Beckham
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Gasteroenterology Associates of Northern Virgina, 3028 Javier Road
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
McGuire DVAMC, 1201 Broad Rock Boulevard
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Bankstown Hospital, Level 3, Department of Gastroenterology, Eldridge Road
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Department of Gastroenterology and Hepatology, Concord Hospital, Hospital Road
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Nepean Hospital, Derby Street
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Department of Gastroenterology, Level 1, Clinic 123, New Clinical Building, Liverpool Hospital, Elizabeth St.
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Department of Gastroenterology and Hepatology, Level 9, Ned Hanlon Building, Royal Brisbane and Women's Hospital Corner Butterfield Street and Bowen Bridge Street
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Hospital Brisbane, Department of Gastroenterology, Raymond Terrace
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Ballarat Health Services, Drummond St North
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Department of Gastroenterology, Eastern Health, ECRU, Level 2, 5 Arnold Street
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Department of Gastroenterology and Hepatology, Cabrini Medical Centre, 183 Wattletree Road
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
MHAT "Sv. Karidad" EAD, Department of Internal Medicine / Gastroenterology, endocrinology and metabolic disorders, 23А, Nikola Vaptsarov Blvd
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
MHAT "Hadzhi Dimitar" OOD, Department of Internal Medicine / Gastroenterology and Endocrinology, 5, Dimitar Pehlivanov str.
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski" EAD; Clinic of Gastroenterology, 15, Akad. Ivan Geshov Blvd.,
City
Sofia
ZIP/Postal Code
1432
Country
Bulgaria
Facility Name
ACIBADEM CITY CLINIC UNIVERSITY HOSPITAL EOOD, Oncology Center, Clinic of Gastroenterology, 66 A, Tsarigradsko shosse Blvd
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
DCC "Mladost-M Varna" OOD, office 528 V, 15, Republika Blvd.
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Facility Name
Discovery Clinical Services Ltd. 601 A Discovery St.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G4
Country
Canada
Facility Name
Mount Sinai Hospital, 600 University Avenue, Suite 445
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Montreal General Hospital Digestive Lab Research Institute McGill University Health Center, 1650 Cedar Avenue C10.145
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
University of Saskatchewan Royal University Hospital, 103 Hospital Drive IBD Clinical Trials Unit Rm 2658
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Nemocnice Horovice, NH Hospital, a.s., Chirurgicke oddeleni, K Nemocnici 1106
City
Horovice
ZIP/Postal Code
268 31
Country
Czechia
Facility Name
Gastroenterologie s.r.o., Manesova 646,
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czechia
Facility Name
HEPATO-GASTROENTEROLOGIE HK, s.r.o., Trida Edvarda Benese 1549/34
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
EGK s.r.o., Sanatorium sv. Anny, Gastroenterologicke oddeleni, Lucni 7a/2776,
City
Praha 3
ZIP/Postal Code
13000
Country
Czechia
Facility Name
IBD centrum / ISCARE IVF a.s., Jankovcova 1569/2c
City
Praha
ZIP/Postal Code
17000
Country
Czechia
Facility Name
ARTROSCAN, s.r.o., Gastroenterologicka ambulance, 5114 Trebovicka, Ostrava
City
Trebovice
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
Krajska zdravotni, a.s., Masarykova nemocnice o.z. Gastroenterologie, Socialni pece 3316/12A
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Assaf HaRofeh Medical Center, Gastroenterology Department, Harofeh Medical Center
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Bnaizion Medical Center, Golomb 47
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
The E. Wolfson Medical Center, 62 Halohamim Str.
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Shaare Zedek Medical Center, Beith Street
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Ein Karem Medical Center, Kiryat Hadassah
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir, 59 Tchemacovsky St
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Galilee Medical Center, P.O.B. 21
City
Nahariya
ZIP/Postal Code
1210001
Country
Israel
Facility Name
Holy Family Hospital, Namsawi St. POB 8
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
RMC Beilinson Hospital, 39 Jabotinsky Street
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sourasky Medical Center, 6 Weizman Street
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Shakespeare Specialist Group, North Shore, Suite 3, 181 Shakespeare Road, Milford Takapuna
City
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
4710
Country
New Zealand
Facility Name
Gastroenterology Unit, Southern District Health Board, 201 Great King Street,
City
Dunedin
ZIP/Postal Code
9054
Country
New Zealand
Facility Name
Department of Gastroenterology,Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Clinical Trials Unit, Tauranga Hospital,
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
NZOZ Specjalistyczne Centrum Gastrologii GASTROMED Wiejska 81
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
SP ZOZ MSWiA w Gdańsku, Oddział Gastroenterologiczny, ul. Kartuska 4/6
City
Gdańsk
ZIP/Postal Code
80-104
Country
Poland
Facility Name
UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA Specjalistyczne Centrum Medyczne Sp. z o.o. Kluczborska 15
City
Krakow
ZIP/Postal Code
31-271
Country
Poland
Facility Name
Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny Żołnierska 18
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
ENDOSKOPIA sp. z o.o. B. Chrobrego 6/8
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
EuroMedis sp. z.o.o., ul. Powstanców Wielkopolskich 33a
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
"GASTROMED" Kopon, Zmudzinski i wspolnicy sp. j., Specjalistyczne Centrum Gastroskopii i Endoskopii, Specjalistyczne Gabinety Lekarskie Grudziadzka 11
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii Woloska 137
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
ARS MEDICA s.c. Rybak Maria, Rybak Zbigniew, Powstancow Slaskich 56A/2
City
Wroclaw
ZIP/Postal Code
53-333
Country
Poland
Facility Name
Centrum Medyczne Szpital Sw. Rodziny Sp. z o.o. Wigury 19
City
Łódź
ZIP/Postal Code
90-302
Country
Poland
Facility Name
: Clinic for Gastroenterology and Hepatology, Clinical Center of Serbia Koste Todorovica 2
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Department of Gastroenterology and Hepatology, Clinic for Internal Diseases, Clinical Hospital Center Zvezdara Dimitrija Tucovica 161
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Department of Gastroenterology and Hepatology, Clinical Hospital Center Zemun Vukova 9
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
: Center for Gastroenterohepatology, Clinic for Internal Medicine, Clinical Center of Kragujevac Zmaj Jovina 30
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
: Clinic of Gastroenterology and Hepatology, Clinical Center of Vojvodina Hajduk Veljkova 1
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Univerzitna nemocnica Bratislava - Nemocnica Ružinov, V. Interná klinika LFUK a UNB, Gastroenterologické a hepatologické oddelenie, Ruzinovska 6
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Univerzitná nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda Gastroenterologická klinika SZU a UNB Antolská 11
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
Breznianske centrum gastroenterologie, s.r.o. Banisko 1
City
Brezno
ZIP/Postal Code
97701
Country
Slovakia
Facility Name
PIGEAS s.r.Prieložtek 1, o.,
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
KM Management spol. s.r.o., Gastroenterologické a hepatologické centrum Nitra, Špitálska 13
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia

12. IPD Sharing Statement

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http://www.redhillbio.com
Description
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Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease

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