Inactive Crohn’s Disease
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Concentration unit: g gram(s)
Concentration type: range
Concentration number: 0.4-4.8
Sponsors
Alimentiv Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older in primary or secondary care. 2. Documented diagnosis of CD previously confirmed by endoscopy and histology at least 3 months prior to enrollment. 3. Taking any brand or dosage of an oral aminosalicylate for at least 6 months prior to enrollment. 4. Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses). 5. CD currently in clinical remission, defined as: a. An HBI score = 4 at enrollment visit AND b. No escalation in medication for the treatment of a CD flare within 3 months prior to enrollment AND c. No use of systemic corticosteroids for CD (2 continuous weeks or more) within the 3 months prior to enrollment AND d. Clinician judgement of disease remission. 6. Able to participate fully in all aspects of the clinical trial. 7. Written informed consent obtained and documented. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis. 2. A diagnosis of short-bowel syndrome. 3. Active perianal disease (note: a history of perianal disease is permitted). 4. Active fistulizing disease (note: a history of fistulizing disease is permitted). 5. A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery. 6. Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment. 7. Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment. 8. Unwillingness to stop taking aminosalicylates for the duration of the trial. 9. Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment. 10. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participants ability to participate fully in the study. 11. History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject’s ability to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine whether withdrawal of aminosalicylates is non-inferior to the continuation of aminosalicylate therapy in participants with Crohn's Disease (CD) in remission with regard to a primary endpoint of any CD-related complication (composite of either a CD-related or CD treatment-related surgery, hospitalization, or other complication) within 24 months after treatment allocation.;Secondary Objective: Any CD-related complication (composite of either a CD-related or CD treatment-related surgery or hospitalization) within first 12 months. Each individual component of the primary composite endpoint within 12 and 24 months. The use of systemic corticosteroids for treatment of CD flares within 12 and 24 months. Time to first CD-related complication (either CD-related or CD treatment-related surgery, hospitalization, or other) and each component individually. Change in disease activity from baseline to 6, 12, and 24 months. Change in quality of life from baseline to 6, 12, and 24 months. Change in C-reactive protein concentration from baseline to 6, 12, and 24 months. Change in faecal calprotectin level from baseline to 12 and 24 months. Estimated CD-related drug treatment costs over the 24 months after enrollment compared to the 12 months prior. Estimated CD-related and total healthcare costs over the 24 months after enrollment compared to the 12 months prior. ;Primary end point(s): The primary efficacy outcome, any CD-related complication (composite of either a CD-related or CD treatment-related surgery, hospitalization, or other complication) will be assessed over 24 months.;Timepoint(s) of evaluation of this end point: 24 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcome evaluations of this study are to compare the effect of withdrawal of aminosalicylates to the continuation of aminosalicylate therapy with regards to: 1. Any CD-related complication (composite of either a CD-related or CD treatment-related surgery, hospitalization, or other complication) within the first 12 months after enrollment. 2. Each individual component of the primary composite endpoint (CD-related or CD-treatment related surgeries, hospitalizations and other complications) within 12 and 24 months after enrollment. 3. The use of systemic corticosteroids for treatment of CD flares within 12 and 24 months after Enrollment. 4. Time to first CD-related complication (either CD-related or CD treatment-related surgery, hospitalization, or other complication) and each component of the composite individually. 5. Change in disease activity from baseline to 6, 12, and 24 months after enrollment, as assessed by changes in the HBI. 6. Change in the quality of life instrument, the CUCQ-32 (Appendix 14.2), from baseline to 6, 12, and 24 months after enrollment. 7. Change in CRP concentration from baseline to 6, 12, and 24 months after enrollment. 8. Change in fecal calprotectin level from baseline to 12 and 24 months after enrollment. 9. Estimated CD-related drug treatment costs over the 24 months after enrollment compared to the 12 months prior to enrollment. 10. Estimated CD-related and total healthcare costs over the 24 months after enrollment compared to the 12 months prior to enrollment. ;Timepoint(s) of evaluation of this end point: 6, 12, and 24 months | — |
Countries
Canada, United Kingdom
Contacts
Public ContactLee Anne Williamson
Alimentiv
Outcome results
None listed