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Long-term Scheduled Therapy With Infliximab in Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057016
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : February 4, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Alessandro Armuzzi, Catholic University of the Sacred Heart

Brief Summary:

The primary objective of this study is to evaluate sustained clinical remission (for the definition see below) in patients with inflammatory bowel disease receiving long-term (> 2 years) scheduled treatment with infliximab.

Secondary objectives include:

  • to identify predictors of sustained clinical remission during long-term infliximab scheduled treatment
  • to identify predictors of loose of response during infliximab scheduled maintenance treatment
  • to identify predictors for maintaining clinical remission in patients who discontinue infliximab because of long-lasting steroid-free clinical remission
  • to evaluate percentage of surgery during and after treatment (total follow-up)
  • to evaluate safety of long-term infliximab scheduled treatment

List the clinical hypotheses

Infliximab is indicated and recommended in moderate to severe inflammatory bowel disease patients who not tolerate or are not responsive to conventional therapies. Most of randomized clinical trials about the use of infliximab in inflammatory bowel diseases are limited to 52 weeks and very few data come from some observational studies about results of prolonged (over one year) treatment with infliximab. No validated predictors of sustained clinical remission or loss of response are available so far. Moreover, few data are available about the hypothetical reduction of IBD related surgery in the "biological era".

In this proposal we suggest the following hypotheses:

  • infliximab scheduled treatment may be efficacious in maintain long-term clinical remission;
  • among clinical, laboratory and endoscopic data some predictors of sustained clinical remission during infliximab long-term scheduled treatment may be found;
  • among clinical, laboratory and endoscopic data some predictors of loss of response during infliximab long-term scheduled treatment may be found;
  • among clinical, laboratory and endoscopic data some predictors of sustained clinical remission after infliximab discontinuation because of long-lasting (> 6 months) steroid-free clinical remission may be found;
  • maintenance of remission with infliximab may reduce rates of surgery over time;
  • long-term scheduled treatment with infliximab may be safe and well tolerated. Results from this study may really help clinicians to make practical decisions in these particular clinical settings.

Condition or disease
Crohn's Disease Ulcerative Colitis

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 258 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Scheduled Therapy With Infliximab in Inflammatory Bowel Disease: a Single-centre Observational Pilot Study
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Efficacy outcome [ Time Frame: 2 years ]
    Evaluation of sustained clinical remission in patients with inflammatory bowel disease receiving long-term (> 2 years) scheduled treatment with infliximab


Secondary Outcome Measures :
  1. Efficacy outcome [ Time Frame: 2 years ]
    Evaluation of predictors of sustained clinical remission during long-term infliximab scheduled treatment, predictors of loose of response during infliximab scheduled maintenance treatment and predictors for maintaining clinical remission in patients who discontinue infliximab because of long-lasting steroid-free clinical remission

  2. Safety outcome: Evaluation of safety of long-term infliximab scheduled treatment. [ Time Frame: 2 years ]

    Adverse events (AE) will be retrospectively reported in the database following this definition of terms.

    Per the International Conference on Harmonization (ICH), an AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

    Serious Adverse Event is any untoward medical occurrence or effect that at any dose: results in death, is life-threatening; requires hospitalization or prolongation of existing inpatients' hospitalization; results in persistent or significant disability or incapacity; and/or is a congenital anomaly or birth defect; is a cancer; is associated with an overdose; is another Important Medical Event.



Other Outcome Measures:
  1. Surgery outcome [ Time Frame: 2 years ]
    Evaluation of percentage of surgery during and after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with inflammatory bowel disease receiving long-term (> 2 years) scheduled treatment with infliximab
Criteria

Inclusion Criteria:

  • patients with inflammatory bowel disease receiving long-term (> 2 years) scheduled treatment with infliximab

Exclusion Criteria:

  • patients with inflammatory bowel disease who received less than 2-year scheduled treatment with infliximab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057016


Locations
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Italy
IBD Unit, Complesso Integrato Columbus, Catholic University of the Sacred Heart
Rome, RM, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Merck Sharp & Dohme Corp.
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Responsible Party: Alessandro Armuzzi, MD PhD, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02057016    
Other Study ID Numbers: LTIT-090114
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases