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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01817426
Date of registration: 29/08/2012
Prospective Registration: Yes
Primary sponsor: Copenhagen University Hospital at Herlev
Public title: Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission STOP IT
Scientific title: Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission: A Multi-center, Double Blinded, Randomized, Placebo Controlled Study
Date of first enrolment: November 2012
Target sample size: 136
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01817426
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Denmark
Contacts
Name:     Sine Schnoor Buhl, M.D.
Address: 
Telephone: +45 51201207
Email: sine_buhl@hotmail.com
Affiliation: 
Name:     Mark Ainsworth, MD.PHD.,DMSc
Address: 
Telephone:
Email:
Affiliation:  Herlev Hospital, dep. of gastroenterology medical section.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Luminal Crohn's disease defined according to standardized diagnostic criteria.

- Age = 18 years.

- IFX induction treatment week 0, 2, 6 followed by maintenance therapy.

- IFX treatment length minimum 12 months. 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:

- CDAI score < 150 and

- Biochemical remission, and

- No other signs of disease activity as evaluated by endoscopic examination 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.

Exclusion Criteria:

- Initial indication for IFX being predominantly 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: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: Infliximab
Other: Placebo
Primary Outcome(s)
Proportion of patients who maintain remission, i.e. CDAI <150 [Time Frame: 48 weeks]
Secondary Outcome(s)
Change from baseline in disease activity. [Time Frame: 48 weeks]
Direct medical costs in the to groups [Time Frame: 48 weeks]
Median time to relapse after discontinuation of IFX [Time Frame: 48 weeks]
Proportion of patients experiencing relapse [Time Frame: 48 weeks]
Proportion of patients who maintain complete remission [Time Frame: 48 weeks]
Secondary ID(s)
02MA
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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