Anti-tumor Necrosis Factor in Patients With Ulcerative Colitis in Clinical Remission: to Continue or Not?

NCT03011268 | Completed DMC

• 2 other identifiers: HMR2016-0.62016-001409-18
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 19

Brief Summary

The primary objective is to assess if discontinuation of anti- tumor necrosis factor alpha (TNF) treatment in ulcerative colitis patients in sustained clinical remission, with the option to restart treatment in the case of relapse, is non-inferior to continued anti-TNF treatment. Secondary objectives are to assess the efficacy and safety of restarting anti-TNF treatment after a relapse

Conditions

Colitis,Ulcerative

Keywords

Tumor Necrosis Factor-alpha/antagonists & inhibitors; Infliximab; Adalimumab; Golimumab; Recurrence

Outcome Measures

Primary Outcomes (1)

• Proportion of patients in sustained clinical remission

  Remission confirmed endoscopically by mucosal healing defined as Mayo Endoscopic Subscore (MES) score 0 or 1 after 2 years of randomized treatment

  2 years

Secondary Outcomes (9)

• Proportion of patients in sustained clinical remission

  4 years

• Time from randomization to relapse

  2 years

• Time from randomization to relapse

  4 years

• Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy

  2 years

• Proportion of patients who are no longer in remission, but who do not need to restart anti-tumor necrosis factor (TNF) therapy

  4 years

Study Arms (2)

Anti TNF discontinuation

EXPERIMENTAL

Discontinuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)

Other: Discontinuation of anti-TNF treatment

Anti TNF continuation

ACTIVE COMPARATOR

Continuation of anti-TNF treatment (Infliximab, Adalimumab, Golimumab)

Other: Continuation of anti-TNF treatment

Interventions

Discontinuation of anti-TNF treatment OTHER

Discontinuation of treatment with Infliximab, Adalimumab, and Golimumab in order to record time to relapse occurrences

Also known as: Remicade, Remsima, Inflectra, Humira, Simponi

Anti TNF discontinuation

Continuation of anti-TNF treatment OTHER

Continuation of treatment with Infliximab, Adalimumab, and Golimumab for 2 years after randomization, then discontinue

Also known as: Remicade, Remsima, Inflectra, Humira, Simponi

Anti TNF continuation

Eligibility Criteria

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

You may qualify if:

• confirmed diagnosis of ulcerative colitis
• treated for minimum 1 year with first-line anti-tumor necrosis factor (TNF) treatment
• in sustained clinical remission during the last 3 months
• capable of understanding and signing an informed consent form

You may not qualify if:

• Discontinuation of systemic 5-Aminosalicylic acid (ASA) or immunomodulatory therapy or other medication that could affect disease activity during the last 3 months prior to randomization
• Any treatment of systemic corticosteroids due to disease exacerbation during the last 3 months (i.e. patients being in steroid free clinical remission)
• Patients on anti-TNF monotherapy with intolerance to both 5-ASA and immunomodulatory therapy
• 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
• Use of any second-line anti-TNF medication irrespective of reason for stopping first-line anti-TNF
• Previous failed attempts of anti-TNF discontinuation of more than 4 months' duration, with the exception of discontinuation due to pregnancy
• Detection of anti-TNF antibodies in moderate-high titers prior to randomization
• Psychiatric or mental disorders
• Alcohol abuse or other substance abuse
• language barriers or other factors which makes adherence to the study protocol impossible
• Participation in any other studies
• pregnancy
• breastfeeding

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• Oslo University Hospital: collaborator
• University of Oslo: collaborator

Study Sites (19)

Helse Møre og Romsdal, Ålesund Sjukehus

Ålesund, Norway

Location

Haraldsplass Diakonale sykehus

Bergen, 5009, Norway

Location

Haukeland Universitetssykehus Helse Bergen HF

Bergen, Norway

Location

Sykehuset Østfold HF Kalnes

Fredrikstad, Norway

Location

Helse Førde, Førde Sentralsjukehus

Førde, Norway

Location

Sykehuset Innlandet, Hamar Sykehus

Hamar, Norway

Location

Universitetssykehuset i Nord-Norge, Harstad

Harstad, Norway

Location

Sørlandet Sykehus HF, Kristiansand

Kristiansand, Norway

Location

Helse Møre og Romsdal, Kristiansund Sjukehus

Kristiansund, Norway

Location

Helse Nord Trøndelag, Levanger Sykehus

Levanger, Norway

Location

Akershus Universitetssykehus, Lørenskog

Lørenskog, 1478, Norway

Location

Oslo Universitetssykehus, Rikshospitalet

Oslo, Norway

Location

Oslo Universitetssykehus, Ullevål

Oslo, Norway

Location

Vestre Viken HF, Bærum Sykehus

Sandvika, Norway

Location

Sykehuset Telemark, Skien

Skien, Norway

Location

Stavanger Universitetssykehus

Stavanger, Norway

Location

Sykehuset Vestfold, Tønsberg

Tønsberg, Norway

Location

Helse Møre og Romsdal, Volda Sjukehus

Volda, Norway

Location

Helse Bergen HF Voss Sjukehus

Voss, Norway

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Recurrence

Interventions

Infliximab; CT-P13; Adalimumab; golimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Officials

• Dag Arne L Hoff, md, phd

  Helse Møre og Romsdal Hospital Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 5, 2017
• Study Start: June 9, 2017
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (19)