Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
- Registration Number
- NCT03627091
- Lead Sponsor
- Shire
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
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Participants and/or their parent or legally authorized representative (LAR) must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
-
Participants must be able to voluntarily provide written, signed, and dated (personally or via a LAR) informed consent and/or assent, as applicable, to participate in the study.
-
Participants must have completed the 16-week induction treatment period from study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at baseline in maintenance study SHP647-307:
- Meet endoscopic response criteria of a reduction in SES-CD from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) or
- Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline:
-
Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO sub scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days* and average daily stool type frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the Bristol Stool Form Scale (BSFS) over the 7 most recent days*.
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A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies baseline.
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A decrease of >=30% and at least 2 points from induction studies baseline in the average daily worst abdominal pain over the 7 most recent days*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction studies baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*.
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A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO sub score of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days*.
*Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.
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Participants receiving any treatments for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
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Participants who had major protocol deviations (as determined by the sponsor) in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
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Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
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Participants who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas).
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Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female participants and medically appropriate methods for male participants) through the conclusion of study participation.
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Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
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Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
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Participants who have developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
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Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
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Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg,] renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
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Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or ECG abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
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Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment.
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Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during the evaluation of the last visit in the induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once prior to enrollment in Study SHP647-307.
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Alanine aminotransferase (ALT) and aspartate aminotransferase levels >= 3.0 × the upper limit of normal (ULN).
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Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the participant has a known documented history of Gilbert's syndrome.
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Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).
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Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or >=1000 × 10^9/L (1,000,000 cells/mm^3).
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White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3).
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Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3)
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Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.
- Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
-
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Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
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Participants who are participating in other investigational studies (other than induction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan to participate in other investigational studies during this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo matched with ontamalimab SC injection using prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). Ontamalimab 25 mg Ontamalimab Participants will receive 25 mg of ontamalimab subcutaneous (SC) injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]). Ontamalimab 75 mg Ontamalimab Participants will receive 75 mg of ontamalimab SC injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]).
- Primary Outcome Measures
Name Time Method Number of Participants With Enhanced Endoscopic Response at Week 52 At Week 52 Enhanced endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 50 percent (%) from induction study (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\] baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non responders. Number of participants with enhanced endoscopic response at Week 52 were reported.
Number of Participants With Clinical Remission at Week 52 At Week 52 Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (\<=) 3 (based on 11 point numerical rating scale \[NRS\] ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]); and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or discontinuation before Week 52 were considered failures. Number of participants with clinical remission at Week 52 were reported.
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52 At Week 52 Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain \<=3 (based on 11-point NRS) over the 7 most recent days and average daily stool frequency \<= 2 of Type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50% from induction study (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]) baseline. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non-responders.
Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52 At Week 52 Clinical remission was defined as a CDAI score of \<150. CDAI assessed CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, \>451 points: severely active to fulminant disease. Higher score indicating more severity. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission as measured by CDAI at Week 52 were reported.
Number of Participants With Sustained Enhanced Endoscopic Response at Week 52 At Week 52 Sustained enhanced endoscopic response was defined as enhanced endoscopic response at both Week 52 visit and the maintenance baseline in this study. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50 % from induction study (either SHP647-305 \[NCT03559517\] or SHP647-306 \[NCT03566823\]) baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Number of participants with sustained enhanced endoscopic response at Week 52 were reported.
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 At Week 52 Glucocorticoid-free clinical remission defined as clinical remission by 2-item PRO not requiring any treatment with glucocorticoids for at least 12 weeks prior to Week 52 visit. Clinical remission defined by 2-item PRO sub-scores of average worst daily abdominal pain \<=3 (based on 11 point NRS ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]); and average daily stool frequency\<=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 were non-responders. Number of participants with glucocorticoid-free clinical remission response at Week 52 were reported.
Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52 At Week 52 Clinical remission was defined by CD daily e-diary 2-item PRO subscores of average daily abdominal pain \<=1 (based on the 4 point scale, with scores ranging from 0 \[none\] to 3 \[severe\]) over the 7 most recent days and average daily stool frequency \<=3 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission based on Crohn's Disease (CD) e-diary Sub-scores for abdominal pain was was reported.
Number of Participants With Complete Endoscopic Healing at Week 52 At Week 52 Complete endoscopic healing was defined as SES-CD scale score from 0-2. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with complete endoscopic healing at Week 52 were reported.
Number of Participants With Sustained Clinical Remission at Week 52 At Week 52 Sustained clinical remission was defined as clinical remission by 2-item PRO at both Week 52 visit and the maintenance baseline in this Study. Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (\<=) 3 (based on 11 point NRS ranging from 0 \[no pain\] to 10 \[worst imaginable pain\]); and average daily stool frequency \<=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Number of participants with sustained clinical remission at Week 52 were reported.
Trial Locations
- Locations (279)
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Hammoud Hospital University Medical Center
🇱🇧Saida, Lebanon
Loretto Hospital
🇺🇸Chicago, Illinois, United States
CATS Research Center - University of Arizona
🇺🇸Tucson, Arizona, United States
Advanced Research Center
🇺🇸Anaheim, California, United States
Kindred Medical Institute for Clinical Trials, LLC
🇺🇸Corona, California, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
🇺🇸Lancaster, California, United States
Alliance Clinical Research-(Vestavia Hills)
🇺🇸Poway, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
Renaissance Research Medical Group, INC
🇺🇸Cape Coral, Florida, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Pharma Research International Inc
🇺🇸Naples, Florida, United States
East Coast Institute for Research, LLC
🇺🇸Saint Augustine, Florida, United States
Atlanta Gastroenterology Specialists, PC
🇺🇸Atlanta, Georgia, United States
Infinite Clinical Trials
🇺🇸Atlanta, Georgia, United States
Atlanta Center For Gastroenterology PC
🇺🇸Decatur, Georgia, United States
Gastroenterology Associates of Hazard
🇺🇸Hazard, Kentucky, United States
Laporte County Institute For Clinical Research
🇺🇸Michigan City, Indiana, United States
CroNOLA, LLC.
🇺🇸Houma, Louisiana, United States
New York Total Medical Care PC
🇺🇸Brooklyn, New York, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
NYU Langone Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Southtowns Gastroenterology, PLLC
🇺🇸Orchard Park, New York, United States
Piedmont Healthcare
🇺🇸Statesville, North Carolina, United States
Consultants For Clinical Research Inc
🇺🇸Fairfield, Ohio, United States
Penn State Hershey Medical Group
🇺🇸State College, Pennsylvania, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Advanced Gastroenterology-Union City
🇺🇸Union City, Tennessee, United States
Precision Research Institute, LLC
🇺🇸Houston, Texas, United States
Biopharma Informatic Inc.
🇺🇸Houston, Texas, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Hospital Privado Centro Médico de Córdoba
🇦🇷Córdoba, Argentina
Mater Hospital Brisbane
🇦🇺South Brisbane, Queensland, Australia
Medizinische Universitat Wien (Medical University of Vienna)
🇦🇹Wien, Austria
CHU Mouscron
🇧🇪Mouscron, Belgium
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
🇧🇬Sofia, Sofia-Grad, Bulgaria
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
🇧🇬Sofia, Bulgaria
Medical Center Excelsior OOD - PPDS
🇧🇬Sofia, Bulgaria
Diagnostic Consultative Centre Mladost - M OOD
🇧🇬Varna, Bulgaria
University Hospital Center Zagreb
🇭🇷Zagreb, Grad Zagreb, Croatia
Opca bolnica Bjelovar
🇭🇷Bjelovar, Croatia
Clinical Hospital Centre Osijek
🇭🇷Osijek, Croatia
General Hospital Virovitica
🇭🇷Virovitica, Croatia
West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Klinikum rechts der Isa der Technischen Universitaet Muenchen
🇩🇪Munich, Bayern, Germany
Universitätsklinikum der RWTH Aachen
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Uniklinik Köln
🇩🇪Köln, Nordrhein-Westfalen, Germany
Gastro Campus Research GbR
🇩🇪Münster, Nordrhein-Westfalen, Germany
Gastroenterologische Facharztpraxis am Mexikoplatz
🇩🇪Berlin-Zehlendorf, Germany
Sana Klinikum Biberach
🇩🇪Biberach an der Riss, Germany
Ippokrateio General Hospital of Athens
🇬🇷Athens, Attiki, Greece
University General Hospital of Heraklion
🇬🇷Heraklion, Greece
Bekes Megyei Kozponti Korhaz
🇭🇺Bekescsaba, Hungary
Tolna Megyei Balassa János Kórház
🇭🇺Szekszard, Hungary
Pannónia Magánorvosi Centrum Kft
🇭🇺Budapest, Hungary
ENDOMEDIX Kft.
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Mohacsi Korhaz
🇭🇺Mohacs, Hungary
St Vincent's University Hospital
🇮🇪Dublin, Ireland
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
🇭🇺Székesfehérvár, Hungary
Baruch Padeh Poriya Medical Center
🇮🇱Tiberias, Israel
Hadassah Medical Center - PPDS
🇮🇱Jerusalem, Israel
Fondazione Policlinico Universitario A Gemelli
🇮🇹Roma, Lazio, Italy
A.O.U. Maggiore della Carità
🇮🇹Novara, Italy
Medical Corporation Aoyama Clinic
🇯🇵Kobe-shi, Hyôgo, Japan
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Ome Municipal General Hospital
🇯🇵Ome, Tokyo, Japan
Kunimoto Hospital
🇯🇵Asahikawa, Japan
Hidaka Coloproctology Clinic
🇯🇵Kurume-shi, Japan
Onomichi General Hospital
🇯🇵Onomichi, Japan
Nishinomiya Municipal Central Hospital
🇯🇵Nishinomiya, Japan
Kinshukai Infusion Clinic
🇯🇵Osaka-shi, Japan
Sapporo Tokushukai Hospital
🇯🇵Sapporo-shi, Japan
Yodogawa Christian Hospital
🇯🇵Osaka, Japan
Sapporo Higashi Tokushukai Hospital
🇯🇵Sapporo, Japan
Nihonbashi Egawa Clinic
🇯🇵Tokyo, Japan
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wonju, Gang'weondo, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inje University Seoul Paik Hospital
🇰🇷Seoul, Korea, Republic of
Al Zahraa University Hospital
🇱🇧Beirut, Lebanon
Vilnius City Clinical Hospital
🇱🇹Vilnius, Lithuania
Vilnius University Hospital Santaros Klinikos
🇱🇹Vilnius, Lithuania
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
🇲🇽Zapopan, Jalisco, Mexico
JM Research S.C
🇲🇽Cuernavaca, Morelos, Mexico
Centro de Investigacion Clinica Acelerada, S.C.
🇲🇽Distrito Federal, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
🇲🇽Durango, Mexico
ETZ-Elisabeth
🇳🇱Tilburg, Noord-Brabant, Netherlands
Dunedin Hospital
🇳🇿Dunedin, South Island, New Zealand
NWZ, location Alkmaar
🇳🇱Den Helder, Noord-Holland, Netherlands
Waikato Hospital
🇳🇿Hamilton, New Zealand
Wellington Hospital
🇳🇿Newtown, Wellington, New Zealand
Melita Medical
🇵🇱Wroclaw, Dolnoslaskie, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
🇵🇱Wloclawek, Kujawsko-pomorskie, Poland
Lexmedica
🇵🇱Wroclaw, Dolnoslaskie, Poland
Vitamed Galaj i Cichomski sp.j.
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
🇵🇱Lódz, Lódzkie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
🇵🇱Warszawa, Mazowieckie, Poland
Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
🇵🇱Warszawa, Mazowieckie, Poland
Miedzyleski Szpital Specjalistyczny w Warszawie
🇵🇱Warszawa, Mazowieckie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Podlaskie, Poland
Endoskopia Sp. z o.o.
🇵🇱Sopot, Pomorskie, Poland
Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
🇵🇱Konskie, Swietokrzyskie, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Zachodniopomorskie, Poland
Centrum Medyczne Czestochowa - PRATIA - PPDS
🇵🇱Czestochowa, Poland
Centrum Medyczne Gdynia - PRATIA - PPDS
🇵🇱Gdynia, Poland
Med Gastr Sp.z.o.o Sp.k
🇵🇱Lodz, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
🇵🇱Poznan, Poland
Centrum Medyczne Warszawa - PRATIA - PPDS
🇵🇱Rzeszow, Poland
Sonomed Sp. z o.o.
🇵🇱Szczecin, Poland
Korczowski Bartosz, Gabinet Lekarski
🇵🇱Rzeszow, Poland
Centrum Zdrowia M D M
🇵🇱Warszawa, Poland
Centralny Szpital Kliniczny MSW
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
🇵🇱Zamosc, Poland
Centro Hospitalar do Algarve - Hospital de Portimao
🇵🇹Portimão, Portugal
Sana Monitoring SRL
🇷🇴Bucharest, Bucuresti, Romania
Cluj-Napoca Emergency Clinical County Hospital
🇷🇴Cluj-Napoca, Cluj, Romania
Colentina Clinical Hospital
🇷🇴Bucharest, Romania
Dr.Carol Davila Emergency University Central Military Hospital
🇷🇴Bucharest, Romania
Centrul Medical Hifu Terramed Conformal S.R.L.
🇷🇴Bucuresti, Romania
Fundeni Clinical Institute
🇷🇴Bucharest, Romania
Prof. Dr. Matei Bals Institute of Infectious Diseases
🇷🇴Bucharest, Romania
Affidea Romania SRL
🇷🇴Constanta, Romania
Gastromedica SRL
🇷🇴Iasi, Romania
Dr. Tirnaveanu Amelita Private Practice
🇷🇴Oradea, Romania
Russian Medical Military Academy n.a. S.M. Kirov
🇷🇺Saint Petersburg, Russian Federation
Rostov State Medical University
🇷🇺Rostov-on-Don, Russian Federation
Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
🇷🇺Samara, Russian Federation
SHI Regional Clinical Hospital
🇷🇺Saratov, Russian Federation
St. Elizabeth Municipal Clinical Hospital
🇷🇺St. Petersburg, Russian Federation
Clinical Hospital Center Bezanijska Kosa
🇷🇸Belgrade, Serbia
University Clinical Center Nis
🇷🇸Nis, Serbia
General Hospital Vrsac
🇷🇸Vrsac, Serbia
Clinical Hospital Center Zemun
🇷🇸Zemun, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Šumadijski Okrug, Serbia
CLINRESCO, ARWYP Medical Suites
🇿🇦Johannesburg, Gauteng, South Africa
Gastro LM, s.r.o.
🇸🇰Presov, Slovakia
Dr. J Breedt
🇿🇦Pretoria, Gauteng, South Africa
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Madrid, Communidad Delaware, Spain
Dr JP Wright
🇿🇦Claremont, Western Cape, South Africa
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Centro Medico Teknon - Grupo Quironsalud
🇪🇸Barcelona, Spain
Hospital Universitario Juan Ramon Jimenez
🇪🇸Huelva, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Mersin University Medical Faculty
🇹🇷Mersin, Turkey
Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
🇺🇦Kharkiv, Kharkivs'ka Oblast, Ukraine
Hospital Universitario La Paz - PPDS
🇪🇸Madrid, Spain
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
🇺🇦Kyiv, Kyïv, Ukraine
Hospital Universitario Virgen del Rocio - PPDS
🇪🇸Sevilla, Spain
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
🇺🇦Kharkiv, Ukraine
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
🇺🇦Kherson, Ukraine
Medical Center of LLC Medical Center Dopomoga-Plus
🇺🇦Kyiv, Ukraine
Municipal Institution of KRC Kyiv Regional Hospital #2
🇺🇦Kyiv, Ukraine
Aberdeen Royal Infirmary - PPDS
🇬🇧Aberdeen, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Royal Gwent Hospital - PPDS
🇬🇧Newport, United Kingdom
BI Research Center
🇺🇸Houston, Texas, United States
Care Access Research, San Pablo
🇺🇸San Pablo, California, United States
IL Gastroenterology Group
🇺🇸Gurnee, Illinois, United States
Digestive Disease Associates
🇺🇸Wyomissing, Pennsylvania, United States
Northside Gastroenterology
🇺🇸Cypress, Texas, United States
Southwest Clinical Trials
🇺🇸Houston, Texas, United States
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
🇺🇸Garland, Texas, United States
Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
🇺🇸Webster, Texas, United States
Mid Atlantic Health Specialists
🇺🇸Galax, Virginia, United States
Unidad de Atencion Medica e Investigacion en Salud
🇲🇽Merida, Yucatán, Mexico
Minnesota Gastroenterology PA
🇺🇸Saint Paul, Minnesota, United States
Mayo Clinic Health System - PPDS
🇺🇸Duluth, Minnesota, United States
Hospital Universitario de Fuenlabrada
🇪🇸Fuenlabrada, Madrid, Spain
Asthma and Allergy Associates PC - CRN - PPDS
🇺🇸Colorado Springs, Colorado, United States
Universitatsklinikum Schleswig-Holstein
🇩🇪Kiel, Schleswig-Holstein, Germany
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Elite Clinical Studies - Phoenix - Clinedge - PPDS
🇺🇸Phoenix, Arizona, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Encompass Care
🇺🇸North Las Vegas, Nevada, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Southern Star Research Institute LLC
🇺🇸San Antonio, Texas, United States
Bayside Clinical Research - New Port Richey
🇺🇸Tampa, Florida, United States
Clinical Research Institute of Michigan
🇺🇸Chesterfield, Michigan, United States
Louisiana Research Center LLC
🇺🇸Shreveport, Louisiana, United States
DBC Research
🇺🇸Tamarac, Florida, United States
Clinical Trials of SWLA, LLC
🇺🇸Lake Charles, Louisiana, United States
Accel Research Sites - St. Petersburg - ERN - PPDS
🇺🇸Pinellas Park, Florida, United States
LKH-Universitätsklinikum Klinikum Graz
🇦🇹Graz, Steiermark, Austria
Arizona Digestive Health Mesa - East
🇺🇸Mesa, Arizona, United States
Hi Tech and Global Research, LLc
🇺🇸Miami, Florida, United States
Advanced Clinical Research Network
🇺🇸Coral Gables, Florida, United States
Fundación Favaloro
🇦🇷Buenos Aires, Argentina
Crystal Biomedical Research
🇺🇸Miami Lakes, Florida, United States
Klinikum Wels-Grieskirchen GmbH
🇦🇹Vienna, Wien, Austria
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Clinical Center Banja Luka
🇧🇦Banja Luka, Bosnia and Herzegovina
Diagnostic and Consulting Center Aleksandrovska EOOD
🇧🇬Sofia, Bulgaria
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Commonwealth Clinical Studies LLC
🇺🇸Brockton, Massachusetts, United States
Gastroenterology Associates of Western Michigan, PLC
🇺🇸Wyoming, Michigan, United States
Sanchez Clinical Research, Inc
🇺🇸Miami, Florida, United States
Atria Clinical Research - Clinedge - PPDS
🇺🇸Little Rock, Arkansas, United States
Alliance Medical Research LLC
🇺🇸Coral Springs, Florida, United States
National Clinical, LLC
🇺🇸Hamtramck, Michigan, United States
SIH Research
🇺🇸Kissimmee, Florida, United States
Academisch Medisch Centrum Amsterdam
🇧🇪Bonheiden, Antwerpen, Belgium
Multiprofile Hospital for Active Treatment Eurohospital
🇧🇬Plovdiv, Bulgaria
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
St Vincents Hospital Melbourne - PPDS
🇦🇺Fitzroy, Victoria, Australia
DelRicht Clinical Research, LLC - ClinEdge - PPDS
🇺🇸New Orleans, Louisiana, United States
Salzburger Landeskliniken
🇦🇹Salzburg, Austria
AZ Groeninge
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Medical Center Convex EOOD
🇧🇬Sofia, Bulgaria
Second Multiprofile Hospital for Active Treatment Sofia
🇧🇬Sofia, Bulgaria
Universitatsklinikum Jena
🇩🇪Jena, Thüringen, Germany
University General Hospital of Patras
🇬🇷Patras, Greece
Azienda Ospedaliero Universitaria Di Modena Policlinico
🇮🇹Modena, Emilia-Romagna, Italy
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
🇧🇬Sofia, Bulgaria
Fondazione IRCCS Policlinico San Matteo di Pavia
🇮🇹Pavia, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Italy
Azienda Ospedaliera Mater Domini Di Catanzaro
🇮🇹Catanzaro, Calabria, Italy
Magyar Honvédség Egészségügyi Központ
🇭🇺Budapest, Hungary
OÜ LV Venter
🇪🇪Parnu, Estonia
Galilee Medical Center
🇮🇱Nahariya, Israel
Fundación Valle Del Lili
🇨🇴Cali, Valle Del Cauca, Colombia
IPS Centro Médico Julián Coronel S.A.S. - PPDS
🇨🇴Cali, Colombia
Euromedica - PPDS
🇬🇷Thessaloniki, Greece
Dokkyo Medical University Hospital
🇯🇵Shimotsuga-gun, Japan
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
🇵🇱Torun, Kujawsko-pomorskie, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
🇵🇱Nowa Sól, Poland
BioVirtus Centrum Medyczne
🇵🇱Warszawa, Poland
Emergency University Hospital
🇷🇴Bucharest, Romania
Medical University Reaviz
🇷🇺Samara, Russian Federation
KM Management, spol. s r.o.
🇸🇰Nitra, Slovakia
Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
🇺🇦Chernivtsi, Chernivets'ka Oblast, Ukraine
Medical Center of LLC Medical Clinic Blagomed
🇺🇦Kyiv, Ukraine
IRCCS Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Veneto, Italy
Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan
La Sapienza-Università di Roma-Policlinico Umberto I
🇮🇹Roma, Italy
Iatriko Palaiou Falirou
🇬🇷Paliao Faliro, Greece
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
🇮🇹San Giovanni Rotondo, Italy
Colo-Proctology Center Matsushima Clinic
🇯🇵Yokohama, Japan
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Poland
NZOZ All Medicus
🇵🇱Katowice, Poland
C.H. Regional Reina Sofia - PPDS
🇪🇸Cordoba, Córdoba, Spain
Medical Center OK!Clinic+LLC International Institute of Clinical Research
🇺🇦Kyiv, Ukraine
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
🇺🇦Lviv, Ukraine
Accelerium, S. de R.L. de C.V.
🇲🇽Monterrey, Nuevo León, Mexico
Hyogo College of Medicine
🇯🇵Nishinomiya-shi, Hyôgo, Japan
Shiga University of Medical Science Hospital
🇯🇵Otsu-Shi, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaidô, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Japan
Chiinkai Dojima General & Gastroenterology Clinic
🇯🇵Osaka, Japan
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon, Gyeonggido, Korea, Republic of
Hospital da Luz
🇵🇹Lisboa, Portugal
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Toho University Sakura Medical Center
🇯🇵Sakura, Japan
Ishida Clinic of IBD and Gastroenterology
🇯🇵Oita-city, Ôita, Japan
LLC Medical Center Family Medicine Clinic
🇺🇦Dnipro, Ukraine
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
🇺🇦Vinnytsia, Ukraine
MNPE City Hospital No. 6 of Zaporizhzhia City Council
🇺🇦Zaporizhzhia, Ukraine
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
🇵🇱Lódz, Lódzkie, Poland
Hospital Senhora da Oliveira - Guimaraes, E.P.E
🇵🇹Guimarães, Portugal
Dr. Goldis Gastroenterology Center SRL
🇷🇴Timisoara, Romania
North Tyneside General Hospital
🇬🇧North Shields, Northumberland, United Kingdom
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Omega Research Consultants LLC - Clinedge - PPDS
🇺🇸Orlando, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Winchester Gastroenterology Associates
🇺🇸Winchester, Massachusetts, United States
HP Clinical Research
🇺🇸Bountiful, Utah, United States
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Clinica de Higado y Gastroenterologia Integral, S.C.
🇲🇽Cuernavaca, Morelos, Mexico