Health Condition 1: K50- Crohns disease [regional enteritis] Health Condition 2: K51- Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Department of Gastroenterology, Dayanand Medical College and Hospital