CTRI/2026/07/113631Active, not recruitingNot Applicable
Therapeutic Drug Monitoring of Azathioprine 6 TGN and 6 MMP in inflammatory Bowel Disease A Pilot Study - NIL
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •Adults aged 18 years or older with a confirmed diagnosis of Crohns disease or
- •ulcerative colitis.
- •Currently receiving azathioprine therapy for maintenance of remission on Azathioprine
- •stable dose, for a minimum of 8 weeks prior to enrollment.
- •Able and willing to provide written informed consent.
Exclusion Criteria
- •Concurrent therapy with allopurinol or febuxostat, as these alter thiopurine metabolism.
- •Presence of an acute severe IBD flare requiring hospitalization at the time of screening.
- •Pregnant or lactating women, due to potential drug related risks.
- •Refusal to participate or inability to provide consent.
Arms & 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 management will undergo therapeutic drug monitoring of 6 TGN and 6 MMP metabolite levels. No study specific intervention, treatment allocation, randomization, or modification of treatment will be performed by the investigators.
Intervention: 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 management will undergo therapeutic drug monitoring of 6 TGN and 6 MMP metabolite levels. No study specific intervention, treatment allocation, randomization, or modification of treatment will be performed by the investigators.
Investigators
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