Long-term Scheduled Therapy With Infliximab in Inflammatory Bowel Disease
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ClinicalTrials.gov Identifier: NCT02057016 |
Recruitment Status :
Completed
First Posted : February 6, 2014
Last Update Posted : February 4, 2015
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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 |
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Crohn's Disease Ulcerative Colitis |

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 |

- 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
- 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
- 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.
- Surgery outcome [ Time Frame: 2 years ]Evaluation of percentage of surgery during and after treatment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
Italy | |
IBD Unit, Complesso Integrato Columbus, Catholic University of the Sacred Heart | |
Rome, RM, Italy, 00168 |
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 |
Crohn Disease Colitis, Ulcerative Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Colitis Colonic Diseases |