Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
- Registration Number
- NCT01124149
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 759
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MMX mesalamine/ mesalazine MMX mesalamine/ mesalazine -
- Primary Outcome Measures
Name Time Method Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase 12 months 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
Name Time Method Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase 12 months 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 Stool Frequency Symptoms During the Acute Phase 3 and 8 weeks 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 Clinical Remission at Month 12 of Maintenance Phase 12 months 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 12 months 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.
Improvement in Rectal Bleeding Score During the Acute Phase 3 and 8 weeks 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).
Percentage of Subjects in Complete Remission at Week 8 of Acute Phase 8 Weeks 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 8 weeks 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).
Trial Locations
- Locations (105)
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Digestive Disorders Associates
🇺🇸Annapolis, Maryland, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Clinical Applications Laboratories, Inc.
🇺🇸San Diego, California, United States
Atlanta Gastroenterology Associates
🇺🇸Marietta, Georgia, United States
Advances Gastroenterology Associates
🇺🇸Palm Harbor, Florida, United States
vzw AZ Groeninge
🇧🇪Kortrijk, Belgium
IKEM (Institute klinicke a experimentalni mediciny)
🇨🇿Prague, Czechia
Imelda General Hospital
🇧🇪Bonheiden, Belgium
Heilig Hart ziekenhuis vzw Roeselare-Menen
🇧🇪Roeselare, Belgium
Promotora medica las Americas S.A.
🇨🇴Medellin, Antioquia, Colombia
Manikya Institute of Gastroenterology & Hepatology
🇮🇳Visakhapatnam, Andhra Pradesh, India
McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
Sahyandri Speciality Hospital
🇮🇳Pune, Maharashtra, India
Mehta Hospital
🇮🇳Ahmedabad, Gujarat, India
Gastroenterology & Endoscopy Centre
🇮🇳Nagpur, Maharashtra, India
S R Kalla Memorial Gastro & General Hospital
🇮🇳Jaipur, Rajasthan, India
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Gastrointestinal Research Associates
🇺🇸Setauket, New York, United States
Ugasend S.A.
🇨🇴Barranquilla, Atlantico, Colombia
Asian Institute of Gastroenterology
🇮🇳Hyderabad, Andhra Pradesh, India
CHU Estaing
🇫🇷Clermont-Ferrand, France
Alpha Recherche Clinique
🇨🇦Quebec City, Quebec, Canada
Institute of Digestive & Liver Diseases
🇮🇳Guwahati, Assam, India
Sree Gokulam Medical College and Research Foundation
🇮🇳Thiruvananthapuram, Kerala, India
Kasturba Medical College Hospital
🇮🇳Mangalore, Kamataka, India
St Vincents' University Hospital
🇮🇪Dublin, Ireland
CMI de Gastroenterologie
🇷🇴Targu Mures, Mures, Romania
Parklands Medical Centre
🇿🇦Durban, KwaZulu Natal, South Africa
EMC Instytut Medyczny SA
🇵🇱Wroclaw, Poland
Clinical Hospital "Dr. I. Cantacuzino"
🇷🇴Bucharest, Romania
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Rose Park Hospital Boanerges CC Trials
🇿🇦Bloemfontein, Free State, South Africa
Dr. Nijhawan Clinic
🇮🇳Jaipur, Rajasthan, India
Greenacres Hospital
🇿🇦Port Elizabeth, South Africa
Beaumont Hospital
🇮🇪Dublin, Ireland
NZOZ Centrum Medyczne HCP
🇵🇱Poznan, Poland
Nzoz Vivamed
🇵🇱Warszawa, Poland
Emergency University Clinical Hospital Bucuresti
🇷🇴Bucharest, Romania
St. Augustine's Hospital
🇿🇦Durban, KwaZulu- Natal, South Africa
Hospital pablo Tobon uribe
🇨🇴Medellin, Antioquia, Colombia
Javorszky Odon Varosi Korhaz, Gasztroenterologia
🇭🇺Vac, Hungary
Panorama Medi-Clinic
🇿🇦Cape Town, Western Cape, South Africa
Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat
🇭🇺Miskolc, Hungary
Adelaide and Meath Hospital
🇮🇪Dublin, Ireland
Policlinic Algomed SRL
🇷🇴Timisoara, Romania
Dayanand Medical College and hospital
🇮🇳Ludhiana, Punjab, India
LexMedica
🇵🇱Wroclaw, Poland
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika
🇭🇺Debrecen, Hungary
Endoskopia Sp z o.o.
🇵🇱Sopot, Poland
Institutul Clinic Fundeni
🇷🇴Bucharest, Romania
Poona Hospital & Research Centre
🇮🇳Pune, Maharashtra, India
John Radcliffe Hospital
🇬🇧Headington, Oxfordshire, United Kingdom
Birmingham Gastroenterology Associates, PC
🇺🇸Birmingham, Alabama, United States
Toronto Digestive Disease Associates, Inc.
🇨🇦Toronto, Ontario, Canada
CHAUQ- Hopital du Saint-Sacrement
🇨🇦Quebec, Canada
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Long Beach VA Medical Center
🇺🇸Long Beach, California, United States
Digestive & Liver Disease Specialists
🇺🇸Garden Grove, California, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Conneticut Gastroenterolgy Institute
🇺🇸Bristol, Connecticut, United States
United Medical Research
🇺🇸New Smyrna Beach, Florida, United States
Atlanta Gastroenterology Associates, LLC
🇺🇸Atlanta, Georgia, United States
Gastrointestinal Clinic of Quad Cities
🇺🇸Davenport, Iowa, United States
Midwest Clinical Research Associates
🇺🇸Moline, Illinois, United States
Delta Research Partners
🇺🇸Monroe, Louisiana, United States
New Orleans Research Institute
🇺🇸Metairie, Louisiana, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Digestive Disease Associates
🇺🇸Baltimore, Maryland, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
Center for Digestive & Liver Disease, Inc.
🇺🇸Mexico, Missouri, United States
Long Island Clinical Research Associates, LLP
🇺🇸Great Neck, New York, United States
LeBauer Research Associates
🇺🇸Greensboro, North Carolina, United States
Ohio Gastroenterolgy and Liver Intstitute
🇺🇸Cincinnati, Ohio, United States
Gastroenterology Associates, LLC
🇺🇸Kingsport, Tennessee, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
S.D. Khan
🇺🇸Houston, Texas, United States
Gastroenterology Clinic of San Antonio, PA
🇺🇸San Antonio, Texas, United States
Colon and Rectal Disease Center
🇺🇸Sandy, Utah, United States
Physicians Research Option, LLC
🇺🇸Sandy, Utah, United States
Wisconsin Center for Advances Research
🇺🇸Milwaukee, Wisconsin, United States
FOQUS, Centro de Investigacion Clinica
🇨🇴Bogota, Cundinamarca, Colombia
Private Gastroenterology centre
🇨🇿Ceske Budejovice, Czechia
Derma Plus s.r.o. Gastroenterology
🇨🇿Ceske Budejovice, Czechia
Hepato-Gastroenterology HK s.r.o.
🇨🇿Hradec Kralove, Czechia
Nemocnice Jablonec nad Nisou
🇨🇿Jablonec nad Nisou, Czechia
Klinicke Centrum ISCARE I.V.F.
🇨🇿Prague 7, Czechia
Faculty hospital Plzen- Lochotin
🇨🇿Plzen, Czechia
Massarykova Nemocnice-Masaryk Hospital
🇨🇿Usti nad Labem, Czechia
Orlickoustecka nemocnice a.s. (Hospital)
🇨🇿Usti nad Orlici, Czechia
Nemocnice Tabor a.s.
🇨🇿Tabor, Czechia
Hopital Saint Andre
🇫🇷Bordeaux, France
CHU Nantes- Hotel Dieu
🇫🇷Nantes, France
Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie
🇩🇪Hannover, Germany
Stawdtisches Klinikum Lueneburg Gastroenterologie
🇩🇪Lueneburg, Germany
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
🇭🇺Gyula, Hungary
Karolina Korhaz, Belgyogyaszat es Gasztroenterologia
🇭🇺Mosonmagyarovar, Hungary
Chhatrapati Shahuji Maharaj Medical University
🇮🇳Lucknow, UP, India
NZOZ Centrum Medyczne Szpital Sw. Rodziny
🇵🇱Lodz, Poland
Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii
🇵🇱Torun, Poland
Policlinica "Dr. Citu" SRL
🇷🇴Timisoara, Romania
Louis Leipoldt Medical Centre
🇿🇦Cape Town, Western Cape, South Africa
Kingsbury Hospital
🇿🇦Cape Town, Western Cape, South Africa
St Mark's Hospital
🇬🇧Harrow, Middlesex, United Kingdom
Alexandria Clinical Research
🇺🇸Alexandria, Virginia, United States