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Monitoring Azathioprine Drug Levels And Their Relationship With Treatment Response And Side Effects In Patients With Inflammatory Bowel Disease

Therapeutic Drug Monitoring of Azathioprine 6 TGN and 6 MMP in inflammatory Bowel Disease A Pilot Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/07/113631
Enrollment
50
Registered
2026-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Intervention1: Azathioprine therapy as part of routine clinical care: This is an observational cohort study. Patients with inflammatory bowel disease receiving azathioprine as part of routine clinical

Sponsors

Kasturba Medical College Mangalore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older with a confirmed diagnosis of Crohns disease or ulcerative colitis. 2. Currently receiving azathioprine therapy for maintenance of remission on Azathioprine stable dose, for a minimum of 8 weeks prior to enrollment. 3. Able and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Concurrent therapy with allopurinol or febuxostat, as these alter thiopurine metabolism. 2. Presence of an acute severe IBD flare requiring hospitalization at the time of screening. 3. Pregnant or lactating women, due to potential drug related risks. 4. Refusal to participate or inability to provide consent.

Design outcomes

Primary

MeasureTime frame
- Quantification of thiopurine metabolite levels namely 6 thioguanine nucleotide and 6 methylmercaptopurine in patients with inflammatory bowel disease receiving azathioprine therapy using high performance liquid chromatography - Association between thiopurine metabolite levels and validated disease activity indices in patients with inflammatory bowel diseaseTimepoint: Baseline and routine follow up visits up to 6 months—

Secondary

MeasureTime frame
- Relationship between weight based azathioprine dose and thiopurine metabolite concentrations - Proportion of patients with subtherapeutic therapeutic and supratherapeutic thiopurine metabolite levels - Association between thiopurine metabolite levels and treatment related adverse effects including myelotoxicity and hepatotoxicity - Assessment of patient adherence using thiopurine metabolite profiles - Characterization of inter individual variability in thiopurine metabolismTimepoint: Baseline and routine follow up visits up to 6 months—

Countries

India

Contacts

Public ContactMural Marshal Lobo

Manipal Academy of Higher Education

preethi.pai@manipal.edu9880750040

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026