A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2009-017044-13-GB
• Date of registration: 17/03/2010
• Prospective Registration: Yes
• Primary sponsor: Shire Development LLC
• Public title: A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis
• Scientific title: A Phase 3b/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 - MOMENTUM
• Date of first enrolment: 30/06/2010
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017044-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium, Canada, Colombia, Czech Republic, France, Germany, Hungary, India, Ireland, Poland, Russian Federation, South Africa, Spain, United Kingdom, United States

Contacts

• Name: Medical Communications
• Affiliation: Shire Pharmaceuticals Ltd

• Name: Medical Communications
• Affiliation: Shire Pharmaceuticals Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects meeting all of the criteria listed below at screening may be included in the study:

1. Adults aged 18 years 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 suspected newly diagnosed with a total score of 4-10 inclusive on the modified UC-DAI with an endoscopy score of ³1 and a PGA of =2).* The original diagnosis of UC must be established by sigmoidoscopy or colonoscopy and have compatible histology (performed prior to screening). An endoscopy with biopsies taken for confirmatory histology will be performed during the screening period for suspected newly diagnosed subjects only.

4. Stable maintenance therapy of 5-ASA =3.2g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare. Stable maintenance therapy is defined as no change in dose, or no initiation of 5-ASA, from the onset of the acute flare through baseline.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 338
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
Subjects are excluded from the study if any of the following criteria are met at screening:

1. Severe UC (assessed by PGA =3).*

2. Acute flare with onset >6 weeks prior to Baseline (Visit 0) while on maintenance
therapy. There is no limit to the onset of flare prior to Baseline (Visit 0) 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 >3.2g/day.

5. Acute flare on a 5-ASA maintenance therapy of >3.2g/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 investigational medicinal product, or clinical or laboratory assessments.

* The symptom parameters of the modified UC-DAI (rectal bleeding and stool frequency) will be assessed at screening and Baseline (Visit 0). Endoscopy scores will be obtained at Baseline (Visit 0) to confirm eligibility, except in the case of suspected newly diagnosed subjects only, where endoscopy with biopsies taken for both confirmatory histology and for central laboratory assessment will be performed during the screening period. For all subjects (including suspected newly diagnosed subjects), the PGA, assessment of subject’s symptoms, and calculation of total UC-DAI score will be performed at Baseline (Visit 0)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative Colitis
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets
Product Name: Mezavant XL
Product Code: SPD476
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Current Sponsor code: SPD476
Other descriptive name: MMX Mesalamine/Mesalazine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1.2-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 29 December 2012

Primary end point(s): The primary efficacy endpoint is to compare the proportion of subjects in complete (clinical and endoscopic) remission after 12 months of maintenance treatment with 2.4g/day MMX mesalamine/mesalazine given QD between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment with 4.8g/day MMX mesalamine/mesalazine given QD.

Complete (clinical and endoscopic) remission is 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 (Visit 0).

Partial remission is defined as a modified UC-DAI =3 with a combined stool frequency and rectal bleeding score of =1 and not in complete remission.

Secondary Objective: 1. To compare the percentage of subjects in clinical remission at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

2. To compare the time to relapse between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

3. To compare the percentage of subjects who achieve or maintain mucosal healing (endoscopy score =1) at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

4. To assess the improvement in symptoms at 3 and 8 weeks of acute treatment.

5. To assess the percentage of subjects who achieve complete remission at the end of 8 weeks acute treatment.

6. To assess the safety and tolerability of MMX mesalamine/mesalazine.

Main Objective: The primary objective of this study is to compare the percentage of subjects in complete (clinical and endoscopic) remission after 12 months of maintenance treatment with 2.4g/day MMX mesalamine/mesalazine given once daily (QD) between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment with 4.8g/day MMX mesalamine/mesalazine given QD.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 29 December 2012

Secondary end point(s): Efficacy
1. To compare the proportion of subjects in clinical remission (stool frequency and rectal bleeding scores equal to 0) at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

2. To compare the time to relapse (the need for alternative treatment for UC [including surgery]) between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

3. To compare the proportion of subjects who achieve or maintain mucosal healing (endoscopy score less than or equal to 1) at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

4. To assess the improvement in symptoms (rectal bleeding and stool frequency) from Baseline (Visit 0) to Weeks 3 and 8 weeks of acute treatment. Improvement is defined as at least a 1 point reduction in the symptom score from Baseline (Visit 0) to each assessment point.

5. To assess the proportion of subjects who achieve complete remission at the end of 8 weeks acute treatment.

Safety
To assess the safety and tolerability of MMX mesalamine/mesalazine throughout the study.

Secondary ID(s)

SPD476-409

Source(s) of Monetary Support

Shire Development LLC

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 20/12/2014
• Date Completed: 14/12/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-017044-13/results