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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 12 December 2016
Main ID:  EUCTR2016-001409-18-NO
Date of registration: 09/05/2016
Prospective Registration: Yes
Primary sponsor: Helse More og Romsdal Hospital Trust
Public title: 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
Scientific title: A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study
Date of first enrolment: 06/12/2016
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001409-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: comparator Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Norway
Contacts
Name: Principal Investigator   
Address:  Aalesund Hospital 6026 Aalesund Norway
Telephone: 004770105000
Email: ingrid.prytz.berset@helse-mr.no
Affiliation:  Helse More & Romsdal Hospital Trust
Name: Principal Investigator   
Address:  Aalesund Hospital 6026 Aalesund Norway
Telephone: 004770105000
Email: ingrid.prytz.berset@helse-mr.no
Affiliation:  Helse More & Romsdal Hospital Trust
Key inclusion & exclusion criteria
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Ulcerative colitis
MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Intervention(s)

Trade Name: 1.Remicade
2.Remsima
3.Inflectra
Pharmaceutical Form: Infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 5-10

Trade Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Simponi
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 100-

Primary Outcome(s)
Main Objective: Primary objective:
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
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
Secondary Objective: Secondary objective: To assess the efficacy and safety of restarting anti-TNF treatment after a relapse
Timepoint(s) of evaluation of this end point: Two years of randomized treatment
Secondary Outcome(s)
Secondary end point(s): 1.Time from randomization to relapse
2.The proportion of patients, who are no longer in remission, but who do not need to restart anti-TNF therapy
3.Proportion of relapse patients achieving remission after anti-TNF restart
Timepoint(s) of evaluation of this end point: Estimated date of last patient completed: 31 December 2022

Secondary ID(s)
HMR2016-0.6
Source(s) of Monetary Support
Helse More & Romsdal Hosptial Trust
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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