Health Condition 1: K509- Crohns disease, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
IPGMER, Kolkata
Eligibility
Inclusion criteria
Inclusion criteria: male and female with confirmed diagnosis of crohns disease. with inadequate response or intolerant to one or more conventional therapy
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of clinical remissionas as per CDAITimepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| acheivement of clinical response as per CDAITimepoint: week 12;maintenance of clinical remission/ reponseTimepoint: 6 months;acheivement of clinical remission as per PROTimepoint: 12 weeks and 6 months;Discontinuation of corticosteroid use for CD per CDAI ( subjects taking corticosteroids for CD at Baseline)Timepoint: week 12;Resolution of draining fistula (subjects with draining fistulas at BaselineTimepoint: week 24;t least 50% decrease from Baseline in the number of days with very soft or liquid stools (Type 6 or 7, per Bristol Stool Chart) during the last 7 days at or 50% decrease in baseline in the pain scoreTimepoint: week 12 and 6 months;High sensitivity C-reactive protein (hs-CRP)Timepoint: week 12 and 6 months | — |
Countries
India
Contacts
Public ContactDr Sumeet chatterjee
IPGMER, Kolkata
Outcome results
None listed