Clinical trial NCT01124149: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ulcerative Colitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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