Discontinuation of infliximab therapy in patients with Crohn's disease in sustained complete remission (the STOP IT study): protocol for a double-blind, randomised, placebo-controlled, multicentre trial.
BMJ Open
; 4(12): e005887, 2014 Dec 18.
Article
in En
| MEDLINE
| ID: mdl-25524543
ABSTRACT
INTRODUCTION:
Infliximab (IFX), a monoclonal chimeric antibody against tumour necrosis factor (TNF) α, is effective for induction and maintenance of remission in moderate to severe Crohn's disease. Discontinuation of IFX maintenance therapy in patients in remission should be considered in order to reduce the potential long-term side effects and lower costs. METHODS ANDANALYSIS:
This is a prospective, double-blind, randomised, placebo-controlled, multicentre study of patients with luminal Crohn's disease who have been treated with IFX for at least 1â year and are in sustained complete clinical, biochemical and endoscopic remission (ie, Crohn's Disease Activity Index (CDAI) score <150, complete mucosal healing and biochemical markers of inflammation within the normal range). These patients are randomised to receive placebo infusions or continue IFX maintenance therapy. The primary end point is the proportion of patients in maintained remission after 48â weeks (def. CDAI <150). ETHICS AND DISSEMINATION It is estimated that the knowledge gained about how to optimally handle patients with Crohn's disease in complete long-term sustained remission on IFX is proportionate to the risks and inconveniences related to participation in this study. Prolonged exposure to IFX may cause severe side effects and increased risk of malignancies. Conversely, IFX discontinuation should not unnecessarily create a high risk of relapse. Thus, empirical evidence is needed concerning the safety of discontinuing IFX once a patient exhibits sustained remission. Study results will be published in an English language scientific medical journal. The study is approved by the Danish Medicines Agency (EudraCT-number 2012-002702-51) and the Regional Ethics Committee of Region Hovedstaden Denmark (Approval-number H-4-2012-099). The project is reported to the Danish Data Protection Agency (ID-number 2007-58-0015/HEH.750.89-27), registered at Clinicaltrials.gov, and monitored by independent GCP units for the University of Copenhagen, Odense and Aarhus. The current approved protocol is V.3.2, dated 1 June 2014. TRIAL REGISTRATION NUMBER http//clinicaltrials.gov/show/NCT01817426.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Crohn Disease
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Anti-Inflammatory Agents, Non-Steroidal
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Maintenance Chemotherapy
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Antibodies, Monoclonal
Type of study:
Clinical_trials
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Guideline
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Observational_studies
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Risk_factors_studies
Aspects:
Ethics
Limits:
Adolescent
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Adult
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Female
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Humans
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Male
Language:
En
Journal:
BMJ Open
Year:
2014
Document type:
Article
Affiliation country:
Denmark