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Biologics in inflammatory bowel disease (IBD)-need and reasons for discontinuation

A study to estimate the proportion of inflammatory bowel disease (IBD) patients needing biological agents and reasons for discontinuation of biologics in our patient population.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/05/025403
Enrollment
400
Registered
2020-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K50-K52- Noninfective enteritis and colitis

Interventions

Intervention1: NIL: NIL

Sponsors

Dr Tarun Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with a confirmed diagnosis of IBD based on diagnostic criteria of IBD Copenhagen Diagnostic Criteria (UC) (all three criteria must be present): (i) History of diarrhea and/or rectal bleeding and pus for more than 1 week or repeated episodes. (ii) Characteristic endoscopic findings of continuous ulceration, vulnerability or granulated mucosa. (iii) Histopathology consistent with UC (neutrophils within epithelial structures, cryptitis, crypt distortion, crypt abscesses). Infection and cancer should be ruled out. Copenhagen Diagnostic Criteria (CD) (at least two criteria must be present): (i) History of abdominal pain, weight loss and/or diarrhoea for more than 3 months. (ii) Characteristic endoscopic findings of ulceration (aphthous lesions, snail track ulcerations), or cobble stoning, or radiological features of stricture. (iii) Histopathology consistent with CD (epithelioid granuloma of Langhans type or transmural, discontinuous focal or patchy inflammation). (iv) Fistula and/or abscesses in addition to affected bowel segments. Infection and cancer should be ruled out. 2. Age group: all age groups

Exclusion criteria

Exclusion criteria: Patients with Inflammatory Bowel Disease (IBD) not giving consent for the study

Design outcomes

Primary

MeasureTime frame
To find the proportion of IBD patients who need biological agents.Timepoint: Prospective part: Patients will be followed for 6 months. 200 patients will be recruited. Retrospective part: 200 patients will be recruited from last 5 years-2014-2019—

Secondary

MeasureTime frame
1. To study the proportion of patient who discontinue biological agents. 2.To study the factors leading to initiation and discontinuation of biological agents in patients with IBDTimepoint: Prospective part: Patients will be followed for 6 months. 200 patients will be recruited. Retrospective part: 200 patients will be recruited from last 5 years-2014-2019—

Countries

India

Contacts

Public ContactDr Vinita Patil

P. D. Hinduja Hospital and Medical Research Centre

vinitapatil.91@gmail.com9619174556

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026