A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence

Phase 1

• Conditions: lcerative colitis; MedDRA version: 19.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-001409-18-NO
• Lead Sponsor: Helse More og Romsdal Hospital Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-09
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.A confirmed diagnosis of ulcerative colitis
2.Male or non-pregnant, non-nursing female
3.>18 years of age at inclusion
4.Patients treated for minimum 1 year with first-line anti-TNF treatment in sustained clinical remission during the last 3 months
5.Subject capable of understanding and signing an informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Discontinuation of systemic 5-ASA or immunomodulatory therapy or other medication that could affect disease activity during the last 3 months prior to randomization
2.Any treatment of systemic corticosteroids due to disease exacerbation during the last 3 months (i.e. patients being in steroid free clinical remission)
3.Patients on anti-TNF monotherapy with intolerance to both 5-ASA and immunomodulatory therapy
4.Change in the anti-TNF treatment during the last 3 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
5.Use of any second-line anti-TNF medication irrespective of reason for stopping first-line anti-TNF
6.Previous failed attempts of anti-TNF discontinuation of more than 4 months’ duration, with the exception of discontinuation due to pregnancy
7.Detection of anti-TNF antibodies in moderate-high titers prior to randomization
8.Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
9.Participation in any other IMP studies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective: <br>To assess if discontinuing anti-TNF treatment in ulcerative colitis (UC) patients in sustained clinical remission, with the option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF therapy ;Secondary Objective: Secondary objective: To assess the efficacy and safety of restarting anti-TNF treatment after a relapse<br>;Primary end point(s): Proportion of patients in sustained clinical remission confirmed endoscopically by mucosal healing defined as MES score 0 or 1 after two years of randomized treatment;Timepoint(s) of evaluation of this end point: Two years of randomized treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Time from randomization to relapse<br>2.The proportion of patients, who are no longer in remission, but who do not need to restart anti-TNF therapy<br>3.Proportion of relapse patients achieving remission after anti-TNF restart <br>;Timepoint(s) of evaluation of this end point: Estimated date of last patient completed: 31 December 2022<br><br>