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National Record on Use of a group of medicines called biologics in patients with Inflammatory Bowel Disease (IBD) including ulcerative colitis and Crohns Disease

The Indian National Registry for use of Biologics in Inflammatory Bowel Disease - Bio-IBD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028759
Enrollment
5000
Registered
2020-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K50- Crohns disease [regional enteritis] Health Condition 2: K51- Ulcerative colitis

Interventions

None listed

Sponsors

Dayanand Medical College and Hospital Ludhiana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with IBD aged >= 18 years at the time of enrolment Written informed consent to participate Subject who has received or planning to receive biologics/biosimilars in routine clinical practice or clinical trials for indications as decided by the site principal investigaor

Exclusion criteria

Exclusion criteria: Age Known HIV positive. Disseminated or advanced malignancy. Concomitant severe underlying systemic illness that in the opinion of the investigator would interfere with completion of follow-up. Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements. Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of study. Inability to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Set up a registry of biologics use in IBD in India to study adequacy of screening before initiation and the safety and effectiveness of the therapy.Timepoint: 1 year, 2 years, 5 years, 10 years

Secondary

MeasureTime frame
Patient outcomes with biologics: EfficacyTimepoint: 1 year, 2 years, 5 years, 10 years;Safety of biologics, including short term and long term adverse events and their outcomes (including surgeries, infections, hospitalization, other life-threatening events and death)Timepoint: 1 year, 2 years, 5 years, 10 years;To study the prescription patterns of biologic use in IBD (both UC and CD) in India.Timepoint: 1 year, 2 years, 5 years, 10 years

Countries

India

Contacts

Public ContactAjit Sood

Department of Gastroenterology, Dayanand Medical College and Hospital

ajitsood10@gmail.com

Outcome results

None listed

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