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Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
MMX mesalamine/ mesalazine
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

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

Inclusion Criteria:

  1. Adults aged 18 or older
  2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol
  3. Diagnosis of active mild to moderate UC (acute flare or newly diagnosed)
  4. Stable maintenance therapy of 5-ASA less than or equal to 3.2 g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare.

Exclusion Criteria:

  1. Severe UC
  2. Acute flare with onset greater than >6 weeks prior to baseline while on maintenance therapy. There is no limit to the onset of flare prior to baseline if the flare is untreated.
  3. Acute flare while on maintenance MMX mesalamine/mesalazine (Lialda, Mezavant, Mezavant XL, Mezavant LP)
  4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2 g/day
  5. Acute flare on a 5-ASA maintenance therapy of >3.2 g/day
  6. Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening
  7. History of biologic (anti-TNF agent) use
  8. Antibiotic use or repeated use (>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted
  9. Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the IMP, or clinical or laboratory assessments

Sites / Locations

  • Birmingham Gastroenterology Associates, PC
  • Advanced Clinical Research Institute
  • Digestive & Liver Disease Specialists
  • Long Beach VA Medical Center
  • Clinical Applications Laboratories, Inc.
  • Conneticut Gastroenterolgy Institute
  • Borland-Groover Clinic
  • United Medical Research
  • Advances Gastroenterology Associates
  • Atlanta Gastroenterology Associates, LLC
  • Atlanta Gastroenterology Associates
  • University of Chicago Medical Center
  • Midwest Clinical Research Associates
  • Gastrointestinal Clinic of Quad Cities
  • New Orleans Research Institute
  • Delta Research Partners
  • Louisiana Research Center, LLC
  • Digestive Disorders Associates
  • Digestive Disease Associates
  • Center for Digestive Health
  • Mayo Clinic
  • Center for Digestive & Liver Disease, Inc.
  • Long Island Clinical Research Associates, LLP
  • Gastrointestinal Research Associates
  • LeBauer Research Associates
  • Ohio Gastroenterolgy and Liver Intstitute
  • Regional Gastroenterology Associates of Lancaster, Ltd.
  • Gastroenterology Associates, LLC
  • S.D. Khan
  • Gastroenterology Clinic of San Antonio, PA
  • Colon and Rectal Disease Center
  • Physicians Research Option, LLC
  • Alexandria Clinical Research
  • Wisconsin Center for Advances Research
  • Imelda General Hospital
  • vzw AZ Groeninge
  • Heilig Hart ziekenhuis vzw Roeselare-Menen
  • McMaster University Medical Centre
  • Toronto Digestive Disease Associates, Inc.
  • Royal Victoria Hospital
  • Alpha Recherche Clinique
  • CHAUQ- Hopital du Saint-Sacrement
  • Hospital pablo Tobon uribe
  • Promotora medica las Americas S.A.
  • Ugasend S.A.
  • FOQUS, Centro de Investigacion Clinica
  • Private Gastroenterology centre
  • Derma Plus s.r.o. Gastroenterology
  • Hepato-Gastroenterology HK s.r.o.
  • Nemocnice Jablonec nad Nisou
  • Faculty hospital Plzen- Lochotin
  • Klinicke Centrum ISCARE I.V.F.
  • IKEM (Institute klinicke a experimentalni mediciny)
  • Nemocnice Tabor a.s.
  • Massarykova Nemocnice-Masaryk Hospital
  • Orlickoustecka nemocnice a.s. (Hospital)
  • Hopital Saint Andre
  • CHU Estaing
  • CHU Nantes- Hotel Dieu
  • Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie
  • Stawdtisches Klinikum Lueneburg Gastroenterologie
  • Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika
  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat
  • Karolina Korhaz, Belgyogyaszat es Gasztroenterologia
  • Javorszky Odon Varosi Korhaz, Gasztroenterologia
  • Asian Institute of Gastroenterology
  • Manikya Institute of Gastroenterology & Hepatology
  • Institute of Digestive & Liver Diseases
  • Mehta Hospital
  • Kasturba Medical College Hospital
  • Sree Gokulam Medical College and Research Foundation
  • Gastroenterology & Endoscopy Centre
  • Sahyandri Speciality Hospital
  • Poona Hospital & Research Centre
  • Dayanand Medical College and hospital
  • S R Kalla Memorial Gastro & General Hospital
  • Dr. Nijhawan Clinic
  • Chhatrapati Shahuji Maharaj Medical University
  • Adelaide and Meath Hospital
  • St Vincents' University Hospital
  • Beaumont Hospital
  • NZOZ Centrum Medyczne Szpital Sw. Rodziny
  • NZOZ Centrum Medyczne HCP
  • Endoskopia Sp z o.o.
  • Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii
  • Nzoz Vivamed
  • LexMedica
  • EMC Instytut Medyczny SA
  • CMI de Gastroenterologie
  • Clinical Hospital "Dr. I. Cantacuzino"
  • Institutul Clinic Fundeni
  • Emergency University Clinical Hospital Bucuresti
  • Policlinic Algomed SRL
  • Policlinica "Dr. Citu" SRL
  • Rose Park Hospital Boanerges CC Trials
  • Parklands Medical Centre
  • St. Augustine's Hospital
  • Panorama Medi-Clinic
  • Louis Leipoldt Medical Centre
  • Kingsbury Hospital
  • Greenacres Hospital
  • Hospital Universitario La Princesa
  • St Mark's Hospital
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MMX mesalamine/ mesalazine

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase
Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

Secondary Outcome Measures

Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase
Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase
Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.
Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase
Subjects with mucosal healing were defined as subjects who had an endoscopy score <=1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).
Improvement in Rectal Bleeding Score During the Acute Phase
Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).
Improvement in Stool Frequency Symptoms During the Acute Phase
Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point. Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Percentage of Subjects in Complete Remission at Week 8 of Acute Phase
Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Percentage of Subjects in Partial Remission at Week 8 of Acute Phase
Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

Full Information

First Posted
May 13, 2010
Last Updated
May 25, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01124149
Brief Title
Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
Official Title
A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 29, 2010 (Actual)
Primary Completion Date
December 7, 2012 (Actual)
Study Completion Date
December 7, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

5. Study Description

Brief Summary
This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
759 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MMX mesalamine/ mesalazine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MMX mesalamine/ mesalazine
Other Intervention Name(s)
Lialda, Mezavant, Mezavant XL, Mezavant LP
Intervention Description
4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months
Primary Outcome Measure Information:
Title
Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase
Description
Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase
Description
Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Time Frame
12 months
Title
Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase
Description
Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.
Time Frame
12 months
Title
Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase
Description
Subjects with mucosal healing were defined as subjects who had an endoscopy score <=1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).
Time Frame
12 months
Title
Improvement in Rectal Bleeding Score During the Acute Phase
Description
Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).
Time Frame
3 and 8 weeks
Title
Improvement in Stool Frequency Symptoms During the Acute Phase
Description
Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point. Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Time Frame
3 and 8 weeks
Title
Percentage of Subjects in Complete Remission at Week 8 of Acute Phase
Description
Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Time Frame
8 Weeks
Title
Percentage of Subjects in Partial Remission at Week 8 of Acute Phase
Description
Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18 or older Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol Diagnosis of active mild to moderate UC (acute flare or newly diagnosed) Stable maintenance therapy of 5-ASA less than or equal to 3.2 g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare. Exclusion Criteria: Severe UC Acute flare with onset greater than >6 weeks prior to baseline while on maintenance therapy. There is no limit to the onset of flare prior to baseline if the flare is untreated. Acute flare while on maintenance MMX mesalamine/mesalazine (Lialda, Mezavant, Mezavant XL, Mezavant LP) Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2 g/day Acute flare on a 5-ASA maintenance therapy of >3.2 g/day Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening History of biologic (anti-TNF agent) use Antibiotic use or repeated use (>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the IMP, or clinical or laboratory assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Gastroenterology Associates, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Digestive & Liver Disease Specialists
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Long Beach VA Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Clinical Applications Laboratories, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Conneticut Gastroenterolgy Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
United Medical Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Advances Gastroenterology Associates
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Atlanta Gastroenterology Associates, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Midwest Clinical Research Associates
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Gastrointestinal Clinic of Quad Cities
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
New Orleans Research Institute
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Digestive Disorders Associates
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Digestive Disease Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Center for Digestive & Liver Disease, Inc.
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Gastrointestinal Research Associates
City
Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
LeBauer Research Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27402
Country
United States
Facility Name
Ohio Gastroenterolgy and Liver Intstitute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Regional Gastroenterology Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
S.D. Khan
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Gastroenterology Clinic of San Antonio, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Colon and Rectal Disease Center
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Physicians Research Option, LLC
City
Sandy
State/Province
Utah
ZIP/Postal Code
84094
Country
United States
Facility Name
Alexandria Clinical Research
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Wisconsin Center for Advances Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Imelda General Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
vzw AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Heilig Hart ziekenhuis vzw Roeselare-Menen
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Toronto Digestive Disease Associates, Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G2B 5S1
Country
Canada
Facility Name
CHAUQ- Hopital du Saint-Sacrement
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Hospital pablo Tobon uribe
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Promotora medica las Americas S.A.
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Ugasend S.A.
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
FOQUS, Centro de Investigacion Clinica
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Private Gastroenterology centre
City
Ceske Budejovice
ZIP/Postal Code
37001
Country
Czechia
Facility Name
Derma Plus s.r.o. Gastroenterology
City
Ceske Budejovice
ZIP/Postal Code
390 01
Country
Czechia
Facility Name
Hepato-Gastroenterology HK s.r.o.
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
Nemocnice Jablonec nad Nisou
City
Jablonec nad Nisou
ZIP/Postal Code
46660
Country
Czechia
Facility Name
Faculty hospital Plzen- Lochotin
City
Plzen
ZIP/Postal Code
30460
Country
Czechia
Facility Name
Klinicke Centrum ISCARE I.V.F.
City
Prague 7
ZIP/Postal Code
17004
Country
Czechia
Facility Name
IKEM (Institute klinicke a experimentalni mediciny)
City
Prague
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Nemocnice Tabor a.s.
City
Tabor
ZIP/Postal Code
39003
Country
Czechia
Facility Name
Massarykova Nemocnice-Masaryk Hospital
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czechia
Facility Name
Orlickoustecka nemocnice a.s. (Hospital)
City
Usti nad Orlici
ZIP/Postal Code
56218
Country
Czechia
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
CHU Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU Nantes- Hotel Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Stawdtisches Klinikum Lueneburg Gastroenterologie
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat
City
Miskolc
ZIP/Postal Code
H-3526
Country
Hungary
Facility Name
Karolina Korhaz, Belgyogyaszat es Gasztroenterologia
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Javorszky Odon Varosi Korhaz, Gasztroenterologia
City
Vac
ZIP/Postal Code
H-2600
Country
Hungary
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Manikya Institute of Gastroenterology & Hepatology
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Institute of Digestive & Liver Diseases
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781006
Country
India
Facility Name
Mehta Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Kasturba Medical College Hospital
City
Mangalore
State/Province
Kamataka
ZIP/Postal Code
575001
Country
India
Facility Name
Sree Gokulam Medical College and Research Foundation
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695607
Country
India
Facility Name
Gastroenterology & Endoscopy Centre
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440 012
Country
India
Facility Name
Sahyandri Speciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Poona Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411030
Country
India
Facility Name
Dayanand Medical College and hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
S R Kalla Memorial Gastro & General Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
Dr. Nijhawan Clinic
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Chhatrapati Shahuji Maharaj Medical University
City
Lucknow
State/Province
UP
ZIP/Postal Code
226003
Country
India
Facility Name
Adelaide and Meath Hospital
City
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
St Vincents' University Hospital
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
NZOZ Centrum Medyczne Szpital Sw. Rodziny
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
NZOZ Centrum Medyczne HCP
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Endoskopia Sp z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii
City
Torun
ZIP/Postal Code
80-100
Country
Poland
Facility Name
Nzoz Vivamed
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
LexMedica
City
Wroclaw
ZIP/Postal Code
50-023
Country
Poland
Facility Name
EMC Instytut Medyczny SA
City
Wroclaw
ZIP/Postal Code
54-144
Country
Poland
Facility Name
CMI de Gastroenterologie
City
Targu Mures
State/Province
Mures
ZIP/Postal Code
540461
Country
Romania
Facility Name
Clinical Hospital "Dr. I. Cantacuzino"
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Emergency University Clinical Hospital Bucuresti
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Policlinic Algomed SRL
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Policlinica "Dr. Citu" SRL
City
Timisoara
ZIP/Postal Code
300593
Country
Romania
Facility Name
Rose Park Hospital Boanerges CC Trials
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Parklands Medical Centre
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
St. Augustine's Hospital
City
Durban
State/Province
KwaZulu- Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Panorama Medi-Clinic
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Louis Leipoldt Medical Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Kingsbury Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Greenacres Hospital
City
Port Elizabeth
ZIP/Postal Code
6057
Country
South Africa
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
St Mark's Hospital
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Headington
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Citations:
PubMed Identifier
32801008
Citation
Stevens TW, Gecse K, Turner JR, de Hertogh G, Rubin DT, D'Haens GR. Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2333-2342. doi: 10.1016/j.cgh.2020.08.019. Epub 2020 Aug 13.
Results Reference
derived
PubMed Identifier
30294708
Citation
Willian MK, D'Haens G, Yarlas A, Joshi AV. Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study. J Patient Rep Outcomes. 2018 Apr 27;2:22. doi: 10.1186/s41687-018-0046-5. eCollection 2018 Dec.
Results Reference
derived
PubMed Identifier
29361097
Citation
Yarlas A, D'Haens G, Willian MK, Teynor M. Health-Related Quality of Life and Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis and Remission Status Following Short-Term and Long-Term Treatment With Multimatrix Mesalamine: A Prospective, Open-Label Study. Inflamm Bowel Dis. 2018 Jan 18;24(2):450-463. doi: 10.1093/ibd/izx041.
Results Reference
derived

Learn more about this trial

Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis

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