Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
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
2 other identifiers
interventional
759
15 countries
105
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2010
Typical duration for phase_4
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2010
CompletedFirst Posted
Study publicly available on registry
May 14, 2010
CompletedStudy Start
First participant enrolled
June 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2012
CompletedResults Posted
Study results publicly available
December 2, 2013
CompletedJune 9, 2021
May 1, 2021
2.4 years
May 13, 2010
September 30, 2013
May 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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).
12 months
Secondary Outcomes (7)
Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase
12 months
Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase
12 months
Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase
12 months
Improvement in Rectal Bleeding Score During the Acute Phase
3 and 8 weeks
Improvement in Stool Frequency Symptoms During the Acute Phase
3 and 8 weeks
- +2 more secondary outcomes
Study Arms (1)
MMX mesalamine/ mesalazine
EXPERIMENTALInterventions
4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (105)
Birmingham Gastroenterology Associates, PC
Birmingham, Alabama, 35209, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Digestive & Liver Disease Specialists
Garden Grove, California, 92840, United States
Long Beach VA Medical Center
Long Beach, California, 90822, United States
Clinical Applications Laboratories, Inc.
San Diego, California, 92103, United States
Conneticut Gastroenterolgy Institute
Bristol, Connecticut, 06010, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
United Medical Research
New Smyrna Beach, Florida, 32168, United States
Advances Gastroenterology Associates
Palm Harbor, Florida, 34684, United States
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, 30342, United States
Atlanta Gastroenterology Associates
Marietta, Georgia, 30067, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Midwest Clinical Research Associates
Moline, Illinois, 61265, United States
Gastrointestinal Clinic of Quad Cities
Davenport, Iowa, 52807, United States
New Orleans Research Institute
Metairie, Louisiana, 70006, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103, United States
Digestive Disorders Associates
Annapolis, Maryland, 21401, United States
Digestive Disease Associates
Baltimore, Maryland, 21229, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Center for Digestive & Liver Disease, Inc.
Mexico, Missouri, 65265, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021, United States
Gastrointestinal Research Associates
Setauket, New York, 11733, United States
LeBauer Research Associates
Greensboro, North Carolina, 27402, United States
Ohio Gastroenterolgy and Liver Intstitute
Cincinnati, Ohio, 45219, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604, United States
Gastroenterology Associates, LLC
Kingsport, Tennessee, 37660, United States
S.D. Khan
Houston, Texas, 77090, United States
Gastroenterology Clinic of San Antonio, PA
San Antonio, Texas, 78229, United States
Colon and Rectal Disease Center
Sandy City, Utah, 84070, United States
Physicians Research Option, LLC
Sandy City, Utah, 84094, United States
Alexandria Clinical Research
Alexandria, Virginia, 22304, United States
Wisconsin Center for Advances Research
Milwaukee, Wisconsin, 53215, United States
Imelda General Hospital
Bonheiden, 2820, Belgium
vzw AZ Groeninge
Kortrijk, 8500, Belgium
Heilig Hart ziekenhuis vzw Roeselare-Menen
Roeselare, 8800, Belgium
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
Toronto Digestive Disease Associates, Inc.
Toronto, Ontario, M3N 2V7, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
CHAUQ- Hopital du Saint-Sacrement
Québec, Quebec, G1S 4L8, Canada
Alpha Recherche Clinique
Québec, Quebec, G2B 5S1, Canada
Hospital pablo Tobon uribe
Medellín, Antioquia, Colombia
Promotora medica las Americas S.A.
Medellín, Antioquia, Colombia
Ugasend S.A.
Barranquilla, Atlántico, Colombia
FOQUS, Centro de Investigacion Clinica
Bogota, Cundinamarca, Colombia
Private Gastroenterology centre
České Budějovice, 37001, Czechia
Derma Plus s.r.o. Gastroenterology
České Budějovice, 390 01, Czechia
Hepato-Gastroenterology HK s.r.o.
Hradec Králové, 50012, Czechia
Nemocnice Jablonec nad Nisou
Jablonec nad Nisou, 46660, Czechia
Faculty hospital Plzen- Lochotin
Pilsen, 30460, Czechia
IKEM (Institute klinicke a experimentalni mediciny)
Prague, 14021, Czechia
Klinicke Centrum ISCARE I.V.F.
Prague, 17004, Czechia
Nemocnice Tabor a.s.
Tábor, 39003, Czechia
Massarykova Nemocnice-Masaryk Hospital
Ústí nad Labem, 40113, Czechia
Orlickoustecka nemocnice a.s. (Hospital)
Ústí nad Orlicí, 56218, Czechia
Hopital Saint Andre
Bordeaux, 33075, France
CHU Estaing
Clermont-Ferrand, 63003, France
CHU Nantes- Hotel Dieu
Nantes, 44000, France
Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie
Hanover, 30625, Germany
Stawdtisches Klinikum Lueneburg Gastroenterologie
Lüneburg, 21339, Germany
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika
Debrecen, H-4032, Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
Gyula, 5700, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat
Miskolc, H-3526, Hungary
Karolina Korhaz, Belgyogyaszat es Gasztroenterologia
Mosonmagyaróvár, 9200, Hungary
Javorszky Odon Varosi Korhaz, Gasztroenterologia
Vác, H-2600, Hungary
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, 500082, India
Manikya Institute of Gastroenterology & Hepatology
Visakhapatnam, Andhra Pradesh, 530002, India
Institute of Digestive & Liver Diseases
Guwahati, Assam, 781006, India
Mehta Hospital
Ahmedabad, Gujarat, 380006, India
Kasturba Medical College Hospital
Mangalore, Kamataka, 575001, India
Sree Gokulam Medical College and Research Foundation
Thiruvananthapuram, Kerala, 695607, India
Gastroenterology & Endoscopy Centre
Nagpur, Maharashtra, 440 012, India
Sahyandri Speciality Hospital
Pune, Maharashtra, 411004, India
Poona Hospital & Research Centre
Pune, Maharashtra, 411030, India
Dayanand Medical College and hospital
Ludhiana, Punjab, 141001, India
S R Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001, India
Dr. Nijhawan Clinic
Jaipur, Rajasthan, 302017, India
Chhatrapati Shahuji Maharaj Medical University
Lucknow, Uttar Pradesh, 226003, India
Adelaide and Meath Hospital
Dublin, 24, Ireland
St Vincents' University Hospital
Dublin, 4, Ireland
Beaumont Hospital
Dublin, 9, Ireland
NZOZ Centrum Medyczne Szpital Sw. Rodziny
Lodz, 90-302, Poland
NZOZ Centrum Medyczne HCP
Poznan, 61-485, Poland
Endoskopia Sp z o.o.
Sopot, 81-756, Poland
Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii
Torun, 80-100, Poland
Nzoz Vivamed
Warsaw, 03-580, Poland
LexMedica
Wroclaw, 50-023, Poland
EMC Instytut Medyczny SA
Wroclaw, 54-144, Poland
CMI de Gastroenterologie
Târgu Mureş, Mureș County, 540461, Romania
Clinical Hospital "Dr. I. Cantacuzino"
Bucharest, 020475, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Emergency University Clinical Hospital Bucuresti
Bucharest, 050098, Romania
Policlinic Algomed SRL
Timișoara, 300002, Romania
Policlinica "Dr. Citu" SRL
Timișoara, 300593, Romania
Rose Park Hospital Boanerges CC Trials
Bloemfontein, Free State, 9301, South Africa
St. Augustine's Hospital
Durban, KwaZulu-Natal, 4001, South Africa
Parklands Medical Centre
Durban, KwaZulu-Natal, 4091, South Africa
Panorama Medi-Clinic
Cape Town, Western Cape, 7500, South Africa
Louis Leipoldt Medical Centre
Cape Town, Western Cape, 7530, South Africa
Kingsbury Hospital
Cape Town, Western Cape, 7708, South Africa
Greenacres Hospital
Port Elizabeth, 6057, South Africa
Hospital Universitario La Princesa
Madrid, 28006, Spain
St Mark's Hospital
Harrow, Middlesex, HA1 3UJ, United Kingdom
John Radcliffe Hospital
Headington, Oxfordshire, OX3 9DU, United Kingdom
Related Publications (3)
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.
PMID: 32801008DERIVEDWillian 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.
PMID: 30294708DERIVEDYarlas 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.
PMID: 29361097DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2010
First Posted
May 14, 2010
Study Start
June 29, 2010
Primary Completion
December 7, 2012
Study Completion
December 7, 2012
Last Updated
June 9, 2021
Results First Posted
December 2, 2013
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.