TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS

NCT06625450 | Not Yet Recruiting Phase 4

• 1 other identifier: TOME
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

All the trials using tofacitinib for maintenance of remission in UC have allowed the use of concomitant therapies except glucocorticoids. Mesalamine, a drug used in mild-to-moderate UC is often continued in patients receiving other drugs for maintenance. In this study, we plan to compare the effect of withdrawing mesalamine and continuing monotherapy with tofacitinib versus continuing dual therapy with tofacitinib and mesalamine. We hypothesize that the continuation of tofacitinib monotherapy after withdrawing mesalamine will be as efficacious and safe as continuation of the combination in remission maintenance in UC.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Time to relapse of colitis

  Relapse of ulcerative colitis will be diagnosed based on the study subject's clinical findings

  12 months

Secondary Outcomes (4)

• Serum biomarker C-reactive protein

  12 months

• Serum biomarker calprotectin

  12 months

• Physician global assessment

  12 months

• Adverse effects

  12 months

Study Arms (2)

Tofacitinib

ACTIVE COMPARATOR

Mesalamine will be withdrawn while tofacitinib will be continued during maintenance of remission of the disease

Drug: Tofacitinib

Tofacitinib plus mesalamine

ACTIVE COMPARATOR

Both mesalamine and tofacitinib will be continued during maintenance of remission of the disease

Drug: Tofacitinib plus mesalamine

Interventions

Tofacitinib DRUG

Tofacitinib alone will be continued at a dose of 11 mg once a day

Tofacitinib

Tofacitinib plus mesalamine DRUG

Both tofacitinib 11 mg once a day and mesalamine will be continued

Tofacitinib plus mesalamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed cases of UC by endoscopy and biopsy
• Patients in clinical remission for at least 3 months on Tofacitinib and mesalamine

You may not qualify if:

• Incomplete evaluation
• Uncertain diagnosis
• Active disease
• Subjects with Crohn's disease, microscopic colitis and collegenous colitis or IBD-U
• Unwilling to participate in study
• Pregnant and lactating women or those who are planning pregnancy in the forthcoming 2 years
• Patients with any suspected or proven malignancy
• Subjects with severe comorbidities
• Prior history of venous thromboembolism.
• Subjects undergoing major surgery
• Myocardial infarction within previous 3 months
• Heart failure

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

tofacitinib; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Central Study Contacts

Beenal Dhooria, MD

CONTACT

+917798152446; braavobeenal@gmail.com

Saroj K Sinha, MD, DM

CONTACT

sarojksinha@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident (DM Fellow)

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 3, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication...for 2 years