Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Treat to target (Escalation of therapy): In the intervention arm or treat to target arm, management will be guided by STRIDE-II recommendations, aiming for escalation of therapy if the
Sponsors
AIIMS NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 80 years 2. Patients with confirmed diagnosis of Ulcerative Colitis by standard clinical, endoscopic and histologic criteria 3. Patients in corticosteroid-free clinical remission as defined by SCCAI less than or equal to 2 and meeting the following criteria: active endoscopic disease (UCEIS more than or equal to 2 and/or elevated biomarkers (FCP more than 150 microgram/g) 4 Patients on stable maintenance therapy for more than or equal to 8 weeks (5 ASA, thiopurine, advanced therapy such as anti-TNF or other biologic or small molecule therapy) 5. Women of childbearing age should agree to avoid conception during the study period. 6. Patients giving written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with clinically active disease (SCCAI score more than 2) 2. Patients with Fulminant colitis or toxic megacolon needing immediate surgery or IV rescue 3. Patients with prior history of surgery for Ulcerative colitis 4. Patients with recent clinical flare of disease and on oral steroids for the same 5. Pregnant and breastfeeding individuals 6. Severe comorbid medical illness a. Cardiac: NYHA II or higher congestive heart failure b. Renal: Creatine clearance (Cockcroft Gault formula) less than 40 ml per min c. Severe hepatic impairment d. Malignancy or a history of malignancy Significant trauma or major surgery within 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the proportion of participants achieving complete remission from the time of randomisation to the end of 12 months of follow-up, defined as a composite of the following criteria: a) Clinical remission: PRO 2 (rectal bleeding score equal to 0 and stool frequency score equal to 0). b) Biochemical remission: Faecal calprotectin (FCP) less than 150 g per gram. c) Endoscopic remission: Ulcerative Colitis Endoscopic Index of Severity (UCEIS) less than or equal to 1 points. Participants must meet all these components concurrently within the 12 month assessment window to be classified as being in complete remission.Timepoint: 3,6,9 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of participants in clinical remission, defined by rectal bleeding score equal to 0 and stool frequency score equal to 0 at the 12 month assessment. 2.Proportion of participants in biochemical remission, defined by faecal calprotectin (FCP) less than 150 microgram per gram at 12 months. 3.Proportion of participants in endoscopic remission, defined by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) less than or equal to 1 at 12 months. 4.Proportion of patients with good quality of life as assessed by the WHOQOL BREF questionnaire and absence of disability as assessed by the IBD DI questionnaire at 12 months.Timepoint: 3,6,9 and 12 months | — |
Countries
India
Contacts
Public ContactDr Vineet Ahuja
AIIMS New Delhi
Outcome results
None listed