History of Changes for Study: NCT01951326

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

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Study Record Versions

Version	Submitted Date	Changes
1	September 23, 2013	None (earliest Version on record)
2	September 29, 2013	Recruitment Status, Contacts/Locations and Study Status
3	November 18, 2013	Contacts/Locations, Study Status and Study Identification
4	November 20, 2013	Contacts/Locations and Study Status
5	November 23, 2013	Contacts/Locations and Study Status
6	November 29, 2013	Contacts/Locations and Study Status
7	December 7, 2013	Contacts/Locations and Study Status
8	December 9, 2013	Contacts/Locations and Study Status
9	December 11, 2013	Contacts/Locations and Study Status
10	January 1, 2014	Contacts/Locations and Study Status
11	January 11, 2014	Contacts/Locations and Study Status
12	January 14, 2014	Contacts/Locations and Study Status
13	January 27, 2014	Contacts/Locations and Study Status
14	February 10, 2014	Contacts/Locations and Study Status
15	March 3, 2014	Contacts/Locations and Study Status
16	March 23, 2014	Contacts/Locations and Study Status
17	March 29, 2014	Contacts/Locations and Study Status
18	April 2, 2014	Contacts/Locations and Study Status
19	April 14, 2014	Eligibility, Outcome Measures and Study Status
20	May 7, 2014	Contacts/Locations and Study Status
21	May 14, 2014	Contacts/Locations and Study Status
22	May 22, 2014	Contacts/Locations and Study Status
23	May 26, 2014	Study Status
24	June 2, 2014	Contacts/Locations and Study Status
25	June 4, 2014	Contacts/Locations and Study Status
26	June 9, 2014	Contacts/Locations and Study Status
27	June 24, 2014	Contacts/Locations and Study Status
28	July 10, 2014	Contacts/Locations and Study Status
29	July 22, 2014	Contacts/Locations and Study Status
30	July 24, 2014	Contacts/Locations and Study Status
31	July 27, 2014	Contacts/Locations and Study Status
32	August 6, 2014	Contacts/Locations and Study Status
33	August 12, 2014	Contacts/Locations and Study Status
34	August 20, 2014	Contacts/Locations and Study Status
35	September 2, 2014	Contacts/Locations and Study Status
36	September 16, 2014	Contacts/Locations and Study Status
37	September 19, 2014	Contacts/Locations and Study Status
38	September 25, 2014	Contacts/Locations and Study Status
39	October 4, 2014	Contacts/Locations and Study Status
40	October 7, 2014	Contacts/Locations and Study Status
41	October 9, 2014	Contacts/Locations and Study Status
42	October 10, 2014	Contacts/Locations and Study Status
43	October 23, 2014	Contacts/Locations and Study Status
44	November 10, 2014	Contacts/Locations and Study Status
45	November 18, 2014	Contacts/Locations and Study Status
46	November 19, 2014	Contacts/Locations and Study Status
47	November 24, 2014	Contacts/Locations and Study Status
48	November 25, 2014	Contacts/Locations and Study Status
49	December 3, 2014	Contacts/Locations and Study Status
50	December 23, 2014	Contacts/Locations and Study Status
51	January 5, 2015	Contacts/Locations and Study Status
52	January 18, 2015	Contacts/Locations and Study Status
53	January 22, 2015	Contacts/Locations and Study Status
54	January 26, 2015	Eligibility and Study Status
55	February 18, 2015	Contacts/Locations and Study Status
56	February 23, 2015	Contacts/Locations and Study Status
57	March 3, 2015	Contacts/Locations and Study Status
58	March 5, 2015	Contacts/Locations and Study Status
59	March 15, 2015	Contacts/Locations and Study Status
60	March 18, 2015	Study Status and Contacts/Locations
61	March 19, 2015	Contacts/Locations and Study Status
62	March 24, 2015	Contacts/Locations and Study Status
63	March 28, 2015	Contacts/Locations and Study Status
64	April 8, 2015	Contacts/Locations and Study Status
65	May 2, 2015	Contacts/Locations and Study Status
66	May 11, 2015	Contacts/Locations and Study Status
67	May 14, 2015	Contacts/Locations and Study Status
68	May 20, 2015	Contacts/Locations and Study Status
69	May 22, 2015	Study Design and Study Status
70	June 6, 2015	Contacts/Locations and Study Status
71	June 18, 2015	Contacts/Locations and Study Status
72	June 28, 2015	Contacts/Locations and Study Status
73	July 1, 2015	Contacts/Locations, Eligibility and Study Status
74	July 26, 2015	Contacts/Locations and Study Status
75	August 5, 2015	Contacts/Locations and Study Status
76	August 12, 2015	Contacts/Locations and Study Status
77	August 19, 2015	Contacts/Locations and Study Status
78	August 23, 2015	Contacts/Locations and Study Status
79	September 10, 2015	Contacts/Locations and Study Status
80	September 13, 2015	Contacts/Locations and Study Status
81	September 17, 2015	Contacts/Locations and Study Status
82	September 18, 2015	Contacts/Locations and Study Status
83	September 28, 2015	Contacts/Locations and Study Status
84	October 1, 2015	Contacts/Locations and Study Status
85	October 4, 2015	Study Status
86	October 10, 2015	Contacts/Locations and Study Status
87	October 26, 2015	Contacts/Locations and Study Status
88	November 16, 2015	Contacts/Locations and Study Status
89	November 18, 2015	Contacts/Locations and Study Status
90	November 19, 2015	Contacts/Locations and Study Status
91	November 24, 2015	Contacts/Locations and Study Status
92	November 25, 2015	Contacts/Locations and Study Status
93	December 1, 2015	Contacts/Locations and Study Status
94	December 7, 2015	Contacts/Locations and Study Status
95	December 15, 2015	Contacts/Locations and Study Status
96	January 17, 2016	Contacts/Locations and Study Status
97	January 28, 2016	Contacts/Locations and Study Status
98	March 8, 2016	Contacts/Locations and Study Status
99	March 10, 2016	Contacts/Locations and Study Status
100	March 27, 2016	Contacts/Locations and Study Status
101	April 1, 2016	Contacts/Locations and Study Status
102	April 9, 2016	Contacts/Locations and Study Status
103	May 8, 2016	Contacts/Locations and Study Status
104	May 10, 2016	Contacts/Locations and Study Status
105	May 13, 2016	Contacts/Locations and Study Status
106	May 17, 2016	Contacts/Locations and Study Status
107	May 28, 2016	Contacts/Locations and Study Status
108	June 19, 2016	Contacts/Locations and Study Status
109	July 5, 2016	Contacts/Locations and Study Status
110	July 10, 2016	Contacts/Locations and Study Status
111	July 11, 2016	Contacts/Locations and Study Status
112	July 13, 2016	Contacts/Locations and Study Status
113	July 14, 2016	Study Status
114	July 25, 2016	Study Status
115	August 1, 2016	Contacts/Locations and Study Status
116	August 4, 2016	Contacts/Locations and Study Status
117	August 12, 2016	Contacts/Locations and Study Status
118	September 3, 2016	Contacts/Locations and Study Status
119	October 6, 2016	Contacts/Locations and Study Status
120	October 9, 2016	Contacts/Locations and Study Status
121	October 16, 2016	Eligibility, Study Design and Study Status
122	November 17, 2016	Contacts/Locations and Study Status
123	November 23, 2016	Contacts/Locations and Study Status
124	December 14, 2016	Contacts/Locations and Study Status
125	February 6, 2017	Contacts/Locations and Study Status
126	February 8, 2017	Contacts/Locations and Study Status
127	February 9, 2017	Study Status and Contacts/Locations
128	March 17, 2017	Contacts/Locations and Study Status
129	March 22, 2017	Contacts/Locations and Study Status
130	April 7, 2017	Contacts/Locations and Study Status
131	April 10, 2017	Contacts/Locations and Study Status
132	April 12, 2017	Contacts/Locations and Study Status
133	May 22, 2017	Contacts/Locations and Study Status
134	May 28, 2017	Contacts/Locations and Study Status
135	June 6, 2017	Contacts/Locations and Study Status
136	June 8, 2017	Contacts/Locations and Study Status
137	June 14, 2017	Contacts/Locations and Study Status
138	June 19, 2017	Contacts/Locations and Study Status
139	August 1, 2017	Eligibility and Study Status
140	August 7, 2017	Contacts/Locations and Study Status
141	August 8, 2017	Contacts/Locations and Study Status
142	August 29, 2017	Contacts/Locations and Study Status
143	September 1, 2017	Contacts/Locations and Study Status
144	October 17, 2017	Recruitment Status, Contacts/Locations, Study Status and Study Design
145	November 3, 2017	Contacts/Locations and Study Status
146	April 12, 2018	Study Status and Contacts/Locations
147	April 12, 2018	Study Status
148	October 4, 2018	Study Status
149	October 28, 2018	Study Status
150	February 27, 2019	Study Status
151	December 29, 2019	Recruitment Status, Study Status, Study Design
	Results Submission Events
March 29, 2020		Returned after QC review: April 10, 2020
152	April 21, 2020	Outcome Measures, Study Status, Document Section and Results
153	June 3, 2020	Study Status
154	June 25, 2020	Study Status
155	July 8, 2020	Study Status
156	October 3, 2020	Study Status
157	November 29, 2020	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	RHB-104-01
Brief Title:	Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease (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
Secondary IDs:

Study Status


Record Verification:	April 2016
Overall Status:	Recruiting
Study Start:	September 2013
Primary Completion:	July 2016 [Anticipated]
Study Completion:	November 2016 [Anticipated]

First Submitted:	September 19, 2013
First Submitted that Met QC Criteria:	September 23, 2013
First Posted:	September 26, 2013 [Estimate]

Last Update Submitted that Met QC Criteria:	April 9, 2016
Last Update Posted:	April 12, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	RedHill Biopharma Limited
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

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.

Conditions


Conditions:	Crohn's Disease
Keywords:	Crohn's Disease moderate to severe remission MAP antibiotic

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	270 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: RHB-104 5 RHB-104 capsules administered orally BID	Drug: RHB-104 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
Placebo Comparator: Placebo 5 placebo capsules administered orally BID	Drug: Placebo 5 placebo capsules administered orally BID

Outcome Measures


Primary Outcome Measures:
1.	Remission at week 26 [ Time Frame: Baseline to week 26 ] Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150
Secondary Outcome Measures:
1.	Response at week 26 [ Time Frame: Baseline to week 26 ] Reduction of CDAI score by a minimum of 100 points
2.	Time to remission and response [ Time Frame: Baseline through week 52 ] The time (weeks after randomization) that a subject first records a state of remission or response.
3.	Duration of remission and response [ Time Frame: Baseline through week 52 ] The time that a subject is in a state of remission or response.
4.	Maintenance of remission [ Time Frame: 52 weeks ] Remission in a subject from week 26 through week 52.
Other Outcome Measures:
1.	Proportion of subjects in remission [ Time Frame: 52 Weeks ]
2.	Proportion of subjects who maintained remission [ Time Frame: Baseline to week 52 ]
3.	RHB-104 plasma concentration measurements at different time points [ Time Frame: Baseline through week 56 ]
4.	Changes in MAP blood status by polymerase chain reaction (PCR) [ Time Frame: Baseline through week 26 ]
5.	Change in Crohn's Disease Endoscopic Index of Severity (CDEIS) [ Time Frame: Baseline through week 26 ]
6.	Change in Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form 36 (SF-36) [ Time Frame: Baseline through Week 52 ]
7.	Change in inflammatory markers [ Time Frame: Baseline through Week 52 ]
8.	Proportion of subjects tapered off steroids [ Time Frame: Baseline through Week 52 ]
9.	Tissue levels of the active agents of RHB-104 in colon biopsy samples [ Time Frame: Baseline to Week 26 ]
10.	Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline through Week 56 ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	75 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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 less 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, or IUD 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. 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 8 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.

Contacts/Locations


Central Contact Person:	Ira N Kalfus, MD Email: ira@redhillbio.com
Central Contact Backup:	To see if you might qualify http://www.mapmycrohns.com
Study Officials:	Ira N Kalfus, MD Study Director RedHill Biopharma
	David Y. Graham, MD Principal Investigator Department of Medicine/Gastroenterology, Baylor College of Medicine, Houston
Locations:	United States, California
	Associated Gastroenterology Medical Group, 1211 W. La Palmak Ave, Suite 303 [Recruiting] Anaheim, California, United States, 92801 Contact:Contact: Mark Gonzalez 714-774-7777 Ext. 575 mgonzalez@azt-trials.com Contact:Principal Investigator: Dennis Riff, MD
	Medvin Clinical Research, 15627 Imperial Highway, [Recruiting] La Mirada, California, United States, 90638 Contact:Contact: Maria Gonzales 562-479-0330 maria@medvinresearch.com Contact:Principal Investigator: Richard McGuire, MD
	Digestive Care Associats, Inc., 1000 Laurel St. [Recruiting] San Carlos, California, United States, 94070 Contact:Contact: MaryAnn Braesesco 650-596-8800 studysite@sbcglobal.net Contact:Principal Investigator: Scott Levenson, MD
	Ventura Clinical Trials, 1746 South Victoria, Suite #230, 220 [Recruiting] Ventura, California, United States, 93003 Contact:Contact: Alex Martinez 800-920-0016 martineza1504@gmail.com Contact:Principal Investigator: Sabine Hazan, MD
	United States, Connecticut
	Medical Research Center of Connecticut, LLC [Recruiting] Hamden, Connecticut, United States, 06518 Contact:Contact: Jennifer Nikolich, RN 203-281-5161 jNikolich@gastrocenter.org Contact:Principal Investigator: Philip Ginsburg, MD
	United States, Florida
	Innovative Medical Research of South Florida, 2999 NE 191 St., Suite 330 [Recruiting] Aventura, Florida, United States, 33180 Contact:Contact: Gabriel Barba 786-202-0998 gbmdresearch@live.com Contact:Principal Investigator: Isaac Bassan, MD
	Clinical Research of West Florida [Recruiting] Clearwater, Florida, United States, 33765 Contact:Contact: Margaret Gray, ARNP 727-466-0078 Ext. 230 mgray@crwf.com Contact:Principal Investigator: Michael Weiss, MD
	Sunrise Medical Research, Inc. 4700 N. State Road Building A, Suite 111 [Recruiting] Lauderdale Lakes, Florida, United States, 33319 Contact:Contact: Sheri P. Alleyne 954-915-9991 sheria@sunrisemedresearch.com Contact:Principal Investigator: Jeffrey Schneider, MD
	Gastroenterology Group of Naples, 1064 Goodlette Road [Recruiting] Naples, Florida, United States, 34102 Contact:Contact: Rose Furgal, RN 239-649-1336 rfurgalresearch@embarqmail.com Contact:Principal Investigator: Raymond W Phillips, MD
	Advanced Research Institute Inc., 7114 Congress Street [Recruiting] New Port Richey, Florida, United States, 34653 Contact:Contact: Christina Arel 727-835-3261 carel@advancedresearchinstitute.net Contact:Principal Investigator: Curtis Freedland, MD
	Endoscopic Research, Inc., 1817 North Mills Avenue [Recruiting] Orlando, Florida, United States, 32802 Contact:Contact: Christina Pacheco 407-241-3289 research@cdhfl.com Contact:Principal Investigator: William Ruderman, MD
	Advanced Medical Research Center, 1690 Dunlawton Ave., Suite 110 [Recruiting] Port Orange, Florida, United States, 32127 Contact:Contact: Deanna Magdziarz 386-767-8800 dmagdziarz@amrcus.com Contact:Contact: Nicole Davis-Cline 386-767-8800 ndavis@amrcus.com Contact:Principal Investigator: Ammar Hemaidan, MD
	United States, Georgia
	Gastrointestinal Specialists of Georgia PC, 711 Canton Rd. Suite 300 [Recruiting] Marietta, Georgia, United States, 30060 Contact:Contact: Cathy Maffei 678-819-4237 cmaffei@gigeorgia.com Contact:Principal Investigator: Aasim Sheikh, MD
	United States, Illinois
	Rush University Medical Center [Recruiting] Chicago, Illinois, United States, 60612 Contact:Contact: Krista Shawron 312-563-3907 krista_shawron@rush.edu Contact:Principal Investigator: Ece Mutlu, MD
	University of Chicago 5841 S. Maryland Ave, MC 4076, Room M404 [Recruiting] Chicago, Illinois, United States, 60637 Contact:Contact: Kristi Milam 773-834-7414 kmilam@medicine.bsd.uchicago.edu Contact:Principal Investigator: Russell D Cohen, MD
	The Carle Foundation, 611 West Park Street [Recruiting] Urbana, Illinois, United States, 61801 Contact:Contact: Paula Bradley, RN, CCRP 217-326-0156 Paula.bradley2@carie.com Contact:Principal Investigator: Glenn Gordon, MD
	United States, Kansas
	Cotton-O'Neil Clinical Research Center, 720 SW Lane St. [Recruiting] Topeka, Kansas, United States, 66606 Contact:Contact: Heather Hirst 785-270-4881 hhirst@stormontvail.org Contact:Principal Investigator: Thomas Welton, MD
	United States, Louisiana
	Delta Research Partners, 608 Grammont Street [Recruiting] Monroe, Louisiana, United States, 71201 Contact:Contact: Melissa McCullars 318-807-0819 drbhandari@suddenlinkmail.com Contact:Principal Investigator: Raj Bhandari, MD
	United States, Maryland
	Investigative Clinical Research, 612 Ridgely Avenue, Suite 401, [Recruiting] Annapolis, Maryland, United States, 21401 Contact:Contact: Robin Doremus 410-224-4887 robin@icrmd.com Contact:Principal Investigator: Michael Epstein, MD
	Chevy Chase Clinical Research, 5550 Friendship Blvd. [Recruiting] Chevy Chase, Maryland, United States, 20815 Contact:Contact: Erin Klepeis 301-652-5520 erin.klepeis@capitaldigestivecare.com Contact:Contact: Kathy Tracey 301-652-5520 kathy.tracey@capitaldigestivecare.com Contact:Principal Investigator: Robert Hardi, MD
	United States, Massachusetts
	Commonwealth Clinical Studies, 189 Quincy St. [Recruiting] Brockton, Massachusetts, United States, 02302-2926 Contact:Contact: Estelle Crowley 508-588-9900 ecrowley@gisdoc.com Contact:Principal Investigator: Mark Finkelstein, MD
	United States, Michigan
	Clinical Research Institute of Michigan, 30795 23 Mile Road, Suite 206 [Recruiting] Chesterfield, Michigan, United States, 48047 Contact:Contact: Aaron Ryder 586-598-3329 aryder@researchmi.com Contact:Principal Investigator: Ronald Fogel, MD
	Center For Digestive Health [Recruiting] Troy, Michigan, United States, 48098 Contact:Contact: Vijay Baragi 734-395-9146 vbaragi@troygastro.com Contact:Principal Investigator: Sante Bologna, MD
	West Michigan Clinical Research Center, 2093 Health Dr. SW, Suite 201 [Recruiting] Wyoming, Michigan, United States, 49519 Contact:Contact: Jeanne Host 616-328-5319 hostjt@yahoo.com Contact:Principal Investigator: Allan Coates, DO
	United States, Mississippi
	Digestive Health Center, 3890 Bienville Blvd. [Recruiting] Ocean Springs, Mississippi, United States, 39564 Contact:Contact: Luan Brown 228-872-7612 browndhc@yahoo.com Contact:Principal Investigator: Alfred E. McNair, MD
	United States, Missouri
	Ehrhardt Clinical Research, LLC, 108 Congress Street [Recruiting] Belton, Missouri, United States, 64012 Contact:Contact: Jody Ehrhardt 816-318-8488 jehrhardt@ecrtrials.com Contact:Principal Investigator: Michael Connor, MD
	United States, New Jersey
	AGA Clinical Research Associates, Inc., 3205 Fire Road [Recruiting] Egg Harbor Township, New Jersey, United States, 08324 Contact:Contact: Theresa Stevens 609-407-1220 theresa@atlanticgastro.com Contact:Principal Investigator: Barry Kaufman, MD
	Holy Name Medical Center, 718 Teaneck Road [Recruiting] Teaneck, New Jersey, United States, 07666 Contact:Contact: Marissa VanOrden 201-541-6384 vanorden@mail.holyname.org Contact:Principal Investigator: Mitchell Spinnel, MD
	United States, New York
	Montefiore Medical Center, 111 East 210th Street [Recruiting] Bronx, New York, United States, 10467 Contact:Contact: Mortadha Abd 347-671-8231 Contact:Principal Investigator: Lawrence Brandt, MD Contact:Sub-Investigator: Olga Aroniadis, MD Contact:Sub-Investigator: Dana Lukin, MD
	North Shore Long Island Jewish Medical Group, 600 Northern Boulevard, Suite 111 [Recruiting] Great Neck, New York, United States, 11021 Contact:Contact: Benly George 516-562-3337 bgeorge7@nshs.edu Contact:Principal Investigator: Keith Sultan, MD
	NYU Langone Long Island , 1000 Northern Boulevard, Suite 160 [Recruiting] Great Neck, New York, United States, 11021 Contact:Contact: Susan Eugene, CRC 516-466-1051 susan.eugene@nyumc.org Contact:Principal Investigator: Robert Tepper, MD
	Manhattan Medical Research Practice PLLC, 215 Lexington Avenue, 21st Floor [Recruiting] New York, New York, United States, 10016 Contact:Contact: Betsy Moclair 917-409-3933 bmoclari@manhattanmedicalresearch.com Contact:Principal Investigator: Ian Lustbader, MD
	United States, North Carolina
	University of North Carolina Center for inflammatory Bowel Diseases, CB 7080, 130 Mason Farm Road, 4151 Bioinformatics Bldg. [Recruiting] Chapel Hill, North Carolina, United States, 27599 Contact:Contact: Mikki Sandridge 919-843-3873 ibdtrials@med.unc.edu Contact:Principal Investigator: Hans Herfarth, MD, PhD
	United States, Ohio
	Ohio GI and Liver Institute, 2925 Vernon Place 100 [Recruiting] Cincinnati, Ohio, United States, 45219 Contact:Contact: Linda Magaw 513-872-4549 magaw@ccrstudy.com Contact:Principal Investigator: Alan Safdi, MD
	Ohio GI and Liver Institute [Recruiting] Cincinnati, Ohio, United States, 45249 Contact:Contact: Amanda Snow 513-587-0410 asnow@ccrstudy.com Contact:Principal Investigator: Christopher South, MD
	United States, Tennessee
	ClinSearch, 6035 Shallowford Road, Suite 109 [Recruiting] Chatanooga, Tennessee, United States, 37421 Contact:Contact: Christy Sweet 423-698-4584 csweet@clinsearch-us.com Contact:Principal Investigator: Richard Krause, MD
	United States, Texas
	Brooke Army Medical Center, 3551 Roger Brooke Drive [Recruiting] Fort Sam Houston, Texas, United States, 78284 Contact:Contact: Susan Kaiser 210-916-4950 susan.j.kaiser2.ctr@mail.mil Contact:Principal Investigator: John G. Gancayco, MD
	Baylor College of Medicine, 7200 Cambridge Street Suite 180.184, 10th Floor [Recruiting] Houston, Texas, United States, 77030 Contact:Contact: Guillermina Cruz 713-798-7616 gcruz@bcm.edu Contact:Principal Investigator: Jason Hou, MD
	University of Texas Health Sciences Center at Houston, 6431 Fannin Street, Medical School Bldg 4-234 [Recruiting] Houston, Texas, United States, 77030 Contact:Contact: Lacie Ford 713-500-6654 Lacie.L.Ford@uth.tmc.edu Contact:Principal Investigator: Nirav Thosani, MD
	Spring Gastroenterology Associates, 8901 FM 1960 West [Recruiting] Humble, Texas, United States, 77036 Contact:Contact: Moniba Rizvi 281-583-5000 Contact:Principal Investigator: Ravi Moparty, MD
	Pasadena Gastroenterology Associates, 4001 Preston Road, Suite 125 [Recruiting] Pasadena, Texas, United States, 77505 Contact:Contact: Steven P Rivas 281-487-4257 steven.rivas@GItrials.com Contact:Principal Investigator: Steven Fein, MD
	Digestive Health Specialists of Tyler, LLP, 1720 S. Beckham [Recruiting] Tyler, Texas, United States, 75701 Contact:Contact: Deborah Nelson 903-595-5101 deborahn@dhstyler.com Contact:Principal Investigator: George DuVall, MD
	United States, Virginia
	Gasteroenterology Associates of Northern Virgina, 3028 Javier Road [Recruiting] Fairfax, Virginia, United States, 22031 Contact:Contact: Fred Lutu 703-698-8960 flutu@novagi.com Contact:Principal Investigator: Keith Mirkin, MD
	McGuire DVAMC, 1201 Broad Rock Boulevard [Recruiting] Richmond, Virginia, United States, 23249 Contact:Contact: Lou Blackman 804-675-6789 lou.blackman@va.gov Contact:Principal Investigator: William Pandak, MD
	United States, Wisconsin
	University of Wisconsin Hospital and Clinics, H6/517 CSC-MC5124, 600 Highland Ave. [Recruiting] Madison, Wisconsin, United States, 53792 Contact:Contact: Jenny Vue 608-262-5404 jxvue@medicine.wisc.edu Contact:Principal Investigator: Mark Reichelderfer, MD
	Medical College of Wisconsin, 9200 W. Wisconsin Ave [Recruiting] Milwaukee, Wisconsin, United States, 53226 Contact:Contact: Sheila Thierfelder 414-955-6804 sthierfe@mcw.edu Contact:Principal Investigator: Daniel Stein, MD
	Australia, New South Wales
	Bankstown Hospital, Level 3, Department of Gastroenterology, Eldridge Road [Recruiting] Bankstown, New South Wales, Australia, 2200 Contact:Contact: Diane Redmond 61-2-9722-8794 Diane.Redmond@sswahs.nsw.gov.au Contact:Principal Investigator: Rupert Leong, MD
	Department of Gastroenterology and Hepatology, Concord Hospital, Hospital Road [Recruiting] Concord, New South Wales, Australia, 2139 Contact:Contact: Melissa Kermeen 61-2-9767-5563 Ext. 61394 Melissa.Kermeen@sswahs.nsw.gov.au Contact:Principal Investigator: Rupert Leong, MD
	Nepean Hospital, Derby Street [Recruiting] Kingswood, New South Wales, Australia, 2747 Contact:Contact: Dianne Stevens 61 2 4734 2435 dianne.stevens@health.nsw.gov.au Contact:Principal Investigator: Martin Weltman, MD
	Department of Gastroenterology, Level 1, Clinic 123, New Clinical Building, Liverpool Hospital, Elizabeth St. [Recruiting] Liverpool, New South Wales, Australia, 2170 Contact:Contact: Elise Sawyer 61-2-8738-4085 elise.sawyer@sswahs.nsw.gov.au Contact:Principal Investigator: Watson Ng, MD
	Department of Gastroenterology, John Hunter Hospital, Lookout Road [Recruiting] New Lambton, New South Wales, Australia, 2305 Contact:Contact: Melissa Young 61 2 4921 4853 melissa.young@hnehealth.nsw.gov.au Contact:Principal Investigator: Steven Bollipo, MD
	Australia, Queensland
	Department of Gastroenterology and Hepatology, Level 9, Ned Hanlon Building, Royal Brisbane and Women's Hospital Corner Butterfield Street and Bowen Bridge Street [Recruiting] Herston, Queensland, Australia, 4029 Contact:Contact: Allison Brown 61-7-3646-4273 Allison.Brown2@health.qld.gov.au Contact:Contact: Madonna McIntyre 61-7-3646-4273 madonna.mcintyre@health.qld.gov.au Contact:Principal Investigator: Mariko Howlett, MD
	Mater Hospital Brisbane, Department of Gastroenterology, Raymond Terrace [Recruiting] South Brisbane, Queensland, Australia, 4101 Contact:Contact: Sharyn Grossman 61-7-3163-8196 Sharyn.grossman@mater.org.au Contact:Principal Investigator: Timothy Florin, MD
	Australia, South Australia
	Centre for Digestive Diseases, Gastroenterology & Hepatology, Royal Adelaide Hospital, Level 7 North Wing, North Terrace [Recruiting] Adelaide, South Australia, Australia, 5000 Contact:Contact: Kerry Kristaly 61-8-8222-5827 kerry.kristaly@health.sa.gov.au Contact:Principal Investigator: David Hetzel, MD
	Flinders Medical Centre, Level 3, Department of Gastroenterology, Flinders Drive [Recruiting] Bedford Park, South Australia, Australia, 5042 Contact:Contact: Helen Lewis 61-8-8204-6062 Helen.Lewis2@health.sa.gov.au Contact:Principal Investigator: A/Prof Peter Bampton, MD
	Australia, Victoria
	Ballarat Health Services, Drummond St North [Recruiting] Ballarat, Victoria, Australia, 3350 Contact:Contact: Carmel Goss 61-3-5320-4735 CarmelG@bhs.org.au Contact:Principal Investigator: MOHAMMED AL-ANSARI, MD
	Department of Gastroenterology, Eastern Health, ECRU, Level 2, 5 Arnold Street [Recruiting] Box Hill, Victoria, Australia, 3128 Contact:Contact: Daniel Van Langenberg, MD 61-3-9094-9533 Daniel.van-Langenberg@monash.edu Contact:Principal Investigator: Daniel Van Langenberg, MD
	Inflammatory Bowel Diseases, Gastroenterology & Hepatology Unit, Department of Medicine, Monash Medical Centre, 246 Clayton Road [Recruiting] Clayton, Victoria, Australia, 3168 Contact:Contact: Amanda Desira 61-3-9594-3577 Amanda.Desira@southernhealth.org.au Contact:Principal Investigator: Gregory Moore, MD
	Department of Gastroenterology and Hepatology, Cabrini Medical Centre, 183 Wattletree Road [Recruiting] Malvern, Victoria, Australia, 3144 Contact:Contact: Emily Coupar +61 3 9508 1862 trials@mgiu.com.au Contact:Principal Investigator: A/Prof Henry Debinski, MD
	Canada, British Columbia
	GI Research Institute, 770-1190 Hornby St [Recruiting] Vancouver, British Columbia, Canada, V6Z 1K5 Contact:Contact: Mari Chris Colman 604-688-6332 Ext. 236 marichriscolman@gmail.com Contact:Principal Investigator: Brian Bressler, MD
	Discovery Clinical Services Ltd. 601 A Discovery St. [Recruiting] Victoria, British Columbia, Canada, V8T 5G4 Contact:Contact: Lisa Warke 250-386-0023 lwarke@dresearch.ca Contact:Principal Investigator: Denis Petrunia, MD
	Canada, Ontario
	Mount Sinai Hospital, 600 University Avenue, Suite 445 [Recruiting] Toronto, Ontario, Canada, M5G 1X5 Contact:Contact: Shelley Mikolainis 416-586-4800 Ext. 4989 smikolainis@mtsinai.on.ca Contact:Principal Investigator: Hilary Steinhart, MD
	Canada, Quebec
	CHUS - - Hôtel Dieu Gastroentérologie, 3001 12th Avenue Nord [Recruiting] Sherbrooke, Quebec, Canada, J1H 5N Contact:Contact: Marc Andre Rodrigue 819-346-1110 Ext. 16216 marodrigue.chus@ssss.gouv.qc.ca Contact:Principal Investigator: Sophie Plamondon, MD
	Canada, Saskatchewan
	University of Saskatchewan Royal University Hospital, 103 Hospital Drive IBD Clinical Trials Unit Rm 2658 [Recruiting] Saskatoon, Saskatchewan, Canada, S7N 0W8 Contact:Contact: Wendi Stumborg 306-655-0691 wendi.stumborg@saskatoonhealthregion.ca Contact:Principal Investigator: Sharyle Fowler, MD
	Israel
	Bnaizion Medical Center, Golomb 47 [Recruiting] Haifa, Israel, 31048 Contact:Contact: Leonid Shpoker 972-505799509 Leonid.Shpoker@B-Zion.org.il Contact:Principal Investigator: Tova Rainis, MD
	The E. Wolfson Medical Center, 62 Halohamim Str. [Recruiting] Holon, Israel, 58100 Contact:Contact: Orit Shevah 972 3 5028482 oritsh@wolfson.health.gov.il Contact:Principal Investigator: Yona Avni, MD
	Shaare Zedek Medical Center, Beith Street [Recruiting] Jerusalem, Israel, 91031 Contact:Contact: Chava Kaniel 972-545 847100 chavak@szmc.org.il Contact:Principal Investigator: Eran Goldin, MD
	Ein Karem Medical Center, Kiryat Hadassah [Recruiting] Jerusalem, Israel, 91120 Contact:Contact: Vera Yitshak 972 2 6777595 verapi@hadassah.org.il Contact:Principal Investigator: Eran Israeli, MD
	Meir, 59 Tchemacovsky St [Recruiting] Kfar-Saba, Israel, 44281 Contact:Contact: Orly Hanin +1 972-9-7471017 orly.hanin@clalit.org.il Contact:Principal Investigator: Fred Konikoff, MD
	Galilee Medical Center, P.O.B. 21 [Recruiting] Nahariya, Israel, 1210001 Contact:Contact: Florencia Kanelo +972 052-5554785 florenciak@clalit.org.il Contact:Principal Investigator: Wisam Sbeit, MD
	Holy Family Hospital, Namsawi St. POB 8 [Recruiting] Nazareth, Israel, 16100 Contact:Contact: Rami Ghantous +972 547 748258 ramighantous@yahoo.com Contact:Principal Investigator: Rifaat Safadi, MD
	RMC Beilinson Hospital, 39 Jabotinsky Street [Recruiting] Petach-Tikva, Israel, 49100 Contact:Contact: Inbal Grossman 972-3-6068194 Inbalgr3@clalit.org.il Contact:Principal Investigator: Irit Avni-Biron, MD
	Sourasky Medical Center, 6 Weizman Street [Recruiting] Tel Aviv, Israel, 64239 Contact:Contact: Smadar Baram +972 3 697-3011 smadarbar@tlvmc.gov.il Contact:Principal Investigator: Sigal Fishman, MD
	Assaf HaRofeh Medical Center, Gastroenterology Department, Harofeh Medical Center [Recruiting] Tsrifin, Israel, 70300 Contact:Contact: Rona Lobel 972 8 977 9655 ronal@asaf.health.gov.il Contact:Principal Investigator: Haim Shirin, MD
	New Zealand
	Shakespeare Specialist Group, North Shore, Suite 3, 181 Shakespeare Road, Milford Takapuna [Recruiting] Auckland, New Zealand, 0620 Contact:Contact: Ian Wallace, MD 64-9-489-2384 iwallace@xtra.co.nz Contact:Principal Investigator: Ian Wallace, MD
	Clinical Trials Unit, Tauranga Hospital, Tauranga [Recruiting] Bay of Plenty, New Zealand, 3112 Contact:Contact: Adrian Claydon, MD 64 7 578 1208 Contact:Principal Investigator: Sundaram Veerappan, MD
	Christchurch Hospital [Recruiting] Christchurch, New Zealand, 4710 Contact:Contact: RICHARD GEARRY, MD +6433640135 richard.gearry@cdhb.health.NZ Contact:Principal Investigator: RICHARD GEARRY, MD
	Gastroenterology Unit, Southern District Health Board, 201 Great King Street, [Recruiting] Dunedin, New Zealand, 9054 Contact:Contact: Merrilee Williams +64-3-474-0999 Ext. 8518 merrilee.williams@southerndhb.govt.nz Contact:Principal Investigator: Michael Schultz, MD
	Department of Gastroenterology,Waikato Hospital [Recruiting] Hamilton, New Zealand, 3240 Contact:Contact: Sherryl Hayett 64-7-839-8899 Ext. 23018 Sherryl.Hayett@waikatodhb.health.nz Contact:Principal Investigator: James Brooker, MD
	Poland
	NZOZ Specjalistyczne Centrum Gastrologii GASTROMED Wiejska 81 [Recruiting] Bialystok, Poland, 15-351 Contact:Contact: Monika Baldowska +48 85 733 6090 Contact:Principal Investigator: Jacek Romatowski, Dr n. med.
	UNICARDIA Specjalistyczne Centrum Leczenia Chorob Serca i Naczyn & UNIMEDICA Specjalistyczne Centrum Medyczne Sp. z o.o. Kluczborska 15 [Recruiting] Krakow, Poland, 31-271 Contact:Contact: Monika Huza Chodacka +48 697 174 075 unicardia@interia.pl Contact:Principal Investigator: Zbigniew Hebzda, Dr n. med.
	Wojewodzki Szpital Kliniczny w Olsztynie Oddzial Gastroenterologiczny Żołnierska 18 [Recruiting] Olsztyn, Poland, 10-561 Contact:Contact: Anna Wos +48 89 538 6475 annawos1982@gmail.com Contact:Principal Investigator: Tomasz Arlukowicz, Dr n. med.
	ENDOSKOPIA sp. z o.o. B. Chrobrego 6/8 [Recruiting] Sopot, Poland, 81-756 Contact:Contact: Dariusz Kleczkowski +48602601103 szach999@wp.pl Contact:Principal Investigator: Marek Horynski, Dr n. med.
	Centrum Medyczne Szpital Sw. Rodziny Sp. z o.o. Wigury 19 [Recruiting] Todz, Poland, 90-302 Contact:Contact: Agnieszka Pacholska, MSc +48 42 254 9624 Contact:Principal Investigator: Maria Wisniewska-Jarosinska, Dr n. med.
	"GASTROMED" Kopon, Zmudzinski i wspolnicy sp. j., Specjalistyczne Centrum Gastroskopii i Endoskopii, Specjalistyczne Gabinety Lekarskie Grudziadzka 11 [Recruiting] Torun, Poland, 87-100 Contact:Contact: Daria Kriks +48790800856 gastromedtrials@gmail.com Contact:Principal Investigator: Adam Kopon, Dr n. med.
	Centralny Szpital Kliniczny MSW w Warszawie Klinika Chorob Wewnetrznych i Gastroenterologii Woloska 137 [Recruiting] Warszawa, Poland, 02-507 Contact:Contact: Beata Stepien beatastepien9@op.pl Contact:Principal Investigator: Grzyna Rydzewska, MD, PhD
	ARS MEDICA s.c. Rybak Maria, Rybak Zbigniew, Powstancow Slaskich 56A/2 [Recruiting] Wroclaw, Poland, 53-333 Contact:Contact: Jadwiga Lapinska, MD, PhD lapinskajadwiga@gmail.com Contact:Principal Investigator: Barbara Wozniak-Stolarska, MD, PhD

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