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

Conditions

Ulcerative Colitis

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.

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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.

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Remission Status Predicts Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis Receiving Short-Term and Long-Term Daily Therapy With Multimatrix Mesalamine

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Long-term Pooled Safety Analysis of Once-Daily Multimatrix Mesalamine

Susana Silva Sanchez, Hong Wan, Paul Streck, Deborah Willshire, Jeffrey B. Raskin

The American Journal of Gastroenterology2014-10-011 citations

10.14309/00000434-201410002-01740

The Impact of Short-Term and Long-Term Daily Treatment With Multimatrix Mesalamine on Disease Burden and on Generic Health-Related Quality of Life in Adult Patients With Mild-to-Moderate Ulcerative Colitis

Mary Kaye Willian, Aaron Yarlas, Joshi Ashish

The American Journal of Gastroenterology2014-10-01

10.14309/00000434-201410002-01750

The Relationship Between Remission Status and Work-Related Outcomes in Patients With Mild-to-Moderate Ulcerative Colitis Who Completed Short-Term and Long-Term Therapy With Multimatrix Mesalamine

Mary Kaye Willian, Aaron Yarlas, Joshi Ashish

The American Journal of Gastroenterology2014-10-01

10.14309/00000434-201410002-01747

Comparison of Long-term Outcomes of MMX Mesalamine Maintenance Treatment for Ulcerative Colitis (UC) between Patients (Pts) in Complete Remission (CR) and Partial Remission (PR) Following Induction

David T. Rubin, S. C. Inglis, Elizabeth Magee, Paul Streck, Dory Solomon et al. (6 authors)

The American Journal of Gastroenterology2013-10-01

10.14309/00000434-201310001-01808

Interventions

DRUGMMX mesalamine/ mesalazine

4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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 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 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).
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).
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).

Countries

Belgium, Canada, Colombia, Czechia, France, Germany, Hungary, India, Ireland, Poland, Romania, South Africa, Spain, United Kingdom, United States

Participant flow

Pre-assignment details

Although 639 subjects completed the Acute Phase, 167 were not eligible to enter the Maintenance Phase due to lack of efficacy and 2 others withdrew prior to entering the maintenance Phase and 1 was withdrawn per IVRS prior to entering the Mainenance Phase. Therefore, 469 subjects entered the Maintenance Phase.

Participants by arm

Arm	Count
MMX Mesalamine/ Mesalazine 4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase	717
Total	717

Withdrawals & dropouts

Period	Reason	FG000
Acute Phase	Adverse Event	21
Acute Phase	Lack of Efficacy	17
Acute Phase	Lost to Follow-up	2
Acute Phase	Low hemoglobin	1
Acute Phase	Non-compliance	1
Acute Phase	Prolonged antibiotic therapy	1
Acute Phase	Protocol Violation	14
Acute Phase	Sponsor decision	1
Acute Phase	Sponsor request	1
Acute Phase	Travelling to another country	1
Acute Phase	UC symptoms not ameliorated	1
Acute Phase	Withdrawal by Subject	22
Maintenance Phase	Adverse Event	24
Maintenance Phase	Coordinator error	1
Maintenance Phase	Lack of Efficacy	40
Maintenance Phase	Lost to Follow-up	15
Maintenance Phase	Non-compliance	1
Maintenance Phase	Protocol Violation	5
Maintenance Phase	Withdrawal by Subject	10

Baseline characteristics

Characteristic	MMX Mesalamine/ Mesalazine
Age, Continuous	42.9 Years STANDARD_DEVIATION 13.97
Age, Customized <=18 years	10 Participants
Age, Customized >=65 years	51 Participants
Age, Customized Between 18 and 65 years	656 Participants
Region of Enrollment BELGIUM	22 Participants
Region of Enrollment CANADA	39 Participants
Region of Enrollment COLOMBIA	74 Participants
Region of Enrollment CZECH REPUBLIC	130 Participants
Region of Enrollment FRANCE	2 Participants
Region of Enrollment HUNGARY	30 Participants
Region of Enrollment INDIA	200 Participants
Region of Enrollment IRELAND	9 Participants
Region of Enrollment POLAND	52 Participants
Region of Enrollment ROMANIA	41 Participants
Region of Enrollment SOUTH AFRICA	21 Participants
Region of Enrollment SPAIN	3 Participants
Region of Enrollment UNITED KINGDOM	3 Participants
Region of Enrollment UNITED STATES	96 Participants
Sex: Female, Male Female	308 Participants
Sex: Female, Male Male	409 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	60 / 717	65 / 461
serious Total, serious adverse events	13 / 717	14 / 461

Outcome results

Primary

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).

Time frame: 12 months

Population: Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.

Arm	Measure	Value (NUMBER)
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase	47.8 percentage of subjects
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)	Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase	26.0 percentage of subjects

p-value: <0.00195% CI: [1.76, 3.87]Regression, Logistic

Secondary

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).

Time frame: 3 and 8 weeks

Population: Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.

Arm	Measure	Group	Value (NUMBER)
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Improvement in Rectal Bleeding Score During the Acute Phase	Week 3	42.4 percentage of subjects
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Improvement in Rectal Bleeding Score During the Acute Phase	Week 8	59.8 percentage of subjects

Secondary

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).

Time frame: 3 and 8 weeks

Population: Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.

Arm	Measure	Group	Value (NUMBER)
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Improvement in Stool Frequency Symptoms During the Acute Phase	3 Weeks	38.5 percentage of subjects
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Improvement in Stool Frequency Symptoms During the Acute Phase	8 Weeks	58.9 percentage of subjects

Secondary

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).

Time frame: 12 months

Population: Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.

Arm	Measure	Value (NUMBER)
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase	58.8 percentage of subjects
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)	Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase	40.4 percentage of subjects

p-value: <0.00195% CI: [1.44, 3.07]Regression, Logistic

Secondary

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).

Time frame: 8 Weeks

Population: Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.

Arm	Measure	Value (NUMBER)
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Percentage of Subjects in Complete Remission at Week 8 of Acute Phase	25.9 percentage of subjects

Secondary

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).

Time frame: 8 weeks

Population: Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.

Arm	Measure	Value (NUMBER)
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Percentage of Subjects in Partial Remission at Week 8 of Acute Phase	39.3 percentage of subjects

Secondary

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).

Time frame: 12 months

Population: Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.

Arm	Measure	Value (NUMBER)
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase	76.4 percentage of subjects
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)	Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase	63.5 percentage of subjects

Secondary

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.

Time frame: 12 months

Population: Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.

Arm	Measure	Value (NUMBER)
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase	6.0 percentage of subjects
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)	Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase	10.5 percentage of subjects

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase

Improvement in Rectal Bleeding Score During the Acute Phase

Improvement in Stool Frequency Symptoms During the Acute Phase

Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase

Percentage of Subjects in Complete Remission at Week 8 of Acute Phase

Percentage of Subjects in Partial Remission at Week 8 of Acute Phase

Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase

Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase