Ulcerative colitis MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
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: r
Sponsors
Helse More og Romsdal Hospital Trust
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;Secondary Objective: Secondary objective: To assess the efficacy and safety of restarting anti-TNF treatment after a relapse ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Norway
Contacts
Public ContactPrincipal Investigator
Helse More & Romsdal Hospital Trust
Outcome results
None listed