Tofacitinib versus Corticosteroids for achieving early clinical response in Patients with Moderate to Severe Ulcerative Colitis

Phase 3

• Conditions: Health Condition 1: K519- Ulcerative colitis, unspecified

• Registration Number: CTRI/2023/11/059730
• Lead Sponsor: All India Institute of Medical Sciences New Delhi Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients with moderate to severe (as defined

by SCCAI score >6 and UCEIS >3)

2. Patients who are on optimum dosage of oral

(minimum 2.4 g per day) and topical 5-ASA

agents, are steroid naïve, or steroid

experienced (last dose >12 weeks prior) but

not on steroids or azathioprine.

3. Anti-TNF/Anti-integrin naïve or

experienced (intolerant or non-responder)

but last dose =2 months back.

4. Concomitant therapy alloweda) Topical steroid and topical 5-ASA

therapy (if stable for last 2 weeks)

b) Budesonide up to 9 mg/day. Stable

dose for at least 2 weeks prior to

baseline period or Budesonide

tapering 3 mg every 3 weekly.

c) Patients on stable doses of oral 5-

ASA (5-amino salicylic acid) for

past 4 weeks.

5. Women of childbearing age should agree to

avoid conception during the study period.

6. Patients giving written informed consent.

Exclusion Criteria

1) Age <18 years, >65 years

2) Patients with acute severe ulcerative colitis

3) Clinical signs of fulminant colitis or toxic

megacolon

4) Patients with a steroid refractory disease.

5) Indeterminate, ischemic, infectious or

Crohn’s colitis

6) Received no treatment for UC in past i.e.,

treatment-naïve

7) If the subject has received the following

therapya. Intravenous corticosteroids within 2

weeks prior to baseline

b. Anti-TNF therapy (e.g., infliximab,

adalimumab, or certolizumab)

within 8 weeks prior to baseline

8) Pregnancy and lactation

9) Concomitant Clostridioides difficile

infection

10) Severe comorbid medical illness

a. Cardiac: NYHA II or higher congestive

heart failure

b. Renal: Creatine clearance (Cockcroft

Gault formula) <40 ml/min

c. Severe hepatic impairment

d. Malignancies or a history of

malignancies

e. Significant trauma or major surgery

within 4 weeks

f. History of bowel surgery within 6

months

12) Contraindication to Tofacitinib including:

a. Severe hepatic impairment

c. Active Tuberculosis

d. H/O deep venous thrombosis DVT or

thrombotic disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified