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A study to compare the effectiveness and safety of high standard dose with low start up dose strategy of azathioprine in patients with ulcerative colitis.

A double blind randomized placebo controlled trial comparing genotype guided standard dosing with conventional dose escalation strategy of azathioprine in patients with ulcerative colitis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025281
Enrollment
100
Registered
2020-05-21
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: K510- Ulcerative (chronic) pancolitis Health Condition 2: K512- Ulcerative (chronic) proctitis Health Condition 3: K513- Ulcerative (chronic) rectosigmoiditis

Interventions

Intervention1: Azathioprine.: Group A: i)NUDT and TPMT both wild type variant: Starting dose of azathioprine will be 2.5 mg /kg/day per oral. ii)NUDT and TPMT both heterozygous:Starting dose of azat

Sponsors

Mukesh Kumar Ranjan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Confirmed cases of ulcerative colitis. 1) Age 18-80 years. 2) Willing to give informed consent. 3) Ulcerative colitis patients who are steroid dependent. 4) Ulcerative colitis patients who are steroid refractory. 5) Patients with acute severe ulcerative colitis (ASUC) after complete response to initial systemic steroid therapy.

Exclusion criteria

Exclusion criteria: 1) Severe cardiac, hepatic and/or renal insufficiency. 2) Active tuberculosis. 3) History of malignancy in last three years. 4) Active viral hepatitis. 5) Comorbidity such as bacterial or viral infection that has not been controlled effectively. 6) Pregnancy. 7) HIV infection. 8) Patients not willing to give consent. 9) Patients with homozygous NUDT 15 and TPMT variant polymorphism.

Design outcomes

Primary

MeasureTime frame
1) Steroid free clinical response at 6 months. 2) Steroid free clinical remission at 6 months. 3) Steroid free endoscopic remission at 6 months. Timepoint: At 6 months of treatment with azathioprine—

Secondary

MeasureTime frame
1) Steroid free endoscopic response at 6 months. 2) Steroid free histological remission at 6 months. 3) Correlation of base line fecal microbiome profile with response to treatment with azathioprine at 6 months. 4) Adverse events at 3 months and 6 months. The major adverse events will include: - Myelotoxicity - Hepatotoxicity - Acute pancreatitis - Gastrointestinal intolerance - Skin manifestations Timepoint: At 6 months of treatment with azathioprine—

Countries

India

Contacts

Public ContactProf Vineet Ahuja

AIIMS, New Delhi, India

vineet.aiims@gmail.com9810707170

Outcome results

None listed

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