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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: 6 October 2020
Main ID:  EUCTR2012-002702-51-SE
Date of registration: 10/06/2015
Prospective Registration: Yes
Primary sponsor: Department of medical gastroenterology S, Odense University Hospital
Public title: Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study
Scientific title: Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT
Date of first enrolment: 10/08/2015
Target sample size: 136
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002702-51
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no 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
Denmark Finland Norway Sweden
Contacts
Name: Sine Buhl Næss-Schmidt   
Address:  Herlev Ringvej 2730 Herlev Denmark
Telephone:
Email: sine.buhl.naess-schmidt@regionh.dk
Affiliation:  Department of medical gastroenterology, Herlev Hospital
Name: Sine Buhl Næss-Schmidt   
Address:  Herlev Ringvej 2730 Herlev Denmark
Telephone:
Email: sine.buhl.naess-schmidt@regionh.dk
Affiliation:  Department of medical gastroenterology, Herlev Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
Primary inclusion criteria:
• Luminal Crohn's disease defined according to standardized diagnostic criteria.
• Age = 18 years.
• IFX treatment length minimum 12 months (minimum 365 days from first IFX administration to last IFX administration prior to inclusion). Episodic therapy with IFX pause > 12 weeks is not accepted within the last year. The treatment interval in the last three months has to be of 6-10 weeks.
• Complete remission defined as:
o Crohn’s Disease Activity Index (CDAI) score < 150,22 and
o Biochemical remission, and
o No other signs of disease activity as evaluated by endoscopic examination, capsule endoscopy or by magnetic resonance imaging (MRI).
• Stable remission, judged by the treating physician, at two consecutive treatments visits corresponding 2 scheduled IFX infusions. Thus, the first visit is during IFX maintaining therapy (screening visit). The second visit is at time of inclusion corresponding time of next scheduled IFX infusion (i.e. after ˜ 8 weeks).
• No use of oral steroids within 3 months prior to inclusion.
• Concomitant therapy with other immune suppressants, except steroids, is allowed. The dosage and frequency must have been stable three months prior to inclusion and must remain stable throughout the study period.

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 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion criteria:
Primary exclusion criteria:
• Initial indication for IFX being predominantly fistulizing perianal disease.
• Active fistulizing perianal disease.
• Any contraindications for continuing IFX treatment, including prior acute or delayed infusion reaction to a TNF- inhibiting agent, any active infection requiring parenteral or oral antibiotic treatment, known infection with tuberculosis, human immunodeficiency virus (HIV) or hepatitis virus.
• Any condition including physician finds incompatible with participation in the study or the patient being unwilling or unable to follow protocol requirements.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab)
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Concentrate for solution for 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
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use

Trade Name: Remsima
Product Name: Remsima
Pharmaceutical Form: Concentrate for solution for infusion

Primary Outcome(s)
Main Objective: The aim of the study is to investigate if infliximab (IFX) can safely and favourably be discontinued in patients with Crohn's disease in sustained complete remission on IFX maintenance therapy.
Primary end point(s): Primary endpoint

The primary endpoint of this study is the proportion of patients who maintain remission, i.e. CDAI <150.

Secondary Objective: Further we will examine the clinical utility of measuring levels/activity of IFX and activity of anti-IFX Ab in patients in sustained complete remission, in order to investigate whether pharmacoimmunological data can predict the clinical outcome and rationalize therapeutic management of these patients with respect to continuation or discontinuation of IFX therapy. Additional, we will investigate the optimal time-point, out of three, to measure this activity.
Timepoint(s) of evaluation of this end point: This endpoint is assessed at 48 weeks.
Secondary Outcome(s)
Secondary end point(s): Secondary endpoints

Patients who continue IFX and patients who discontinue IFX are compared with respect to the following at 48 weeks after inclusion:

• Proportion of patients who maintain complete remission.
• Proportion of patients experiencing relapse.
• The proportion of patients, who are no longer in remission, but are not in relapse.
• Median time to relapse after discontinuation of IFX.
• Change from baseline in disease activity evaluated by: CDAI as assessed by CDAI score, quality of life (QoL) as assessed by short-IBDQ, work productivity and activity as assessed by WPAI, biochemical markers assessed by, i.e. C-reactive protein (CRP), platelets, white blood cell (WBC) count, Hemoglobin (Hb) and fecal calprotectin and colonoscopy (scored by the SES-CD) / MR imaging.
• Economical expenses in the to groups.
Timepoint(s) of evaluation of this end point: Endpoints are assessed at 48 weeks
Secondary ID(s)
010951201207
2012-002702-51-DK
Source(s) of Monetary Support
Norforsk/ Region Hovedstadens forskningsfond/ other independent funds
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 09/06/2015
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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