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Managing Infliximab Reinduction After Temporary Discontinuation of Drug

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ClinicalTrials.gov Identifier: NCT02771457
Recruitment Status : Withdrawn
First Posted : May 13, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Drug: Infliximab at weeks 0,2, and 6 Drug: Infliximab at weeks 0,4, and 8 Drug: Infliximab at weeks 0 and 8 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Managing Infliximab Reinduction After Temporary Discontinuation of Drug
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Infliximab at weeks 0,2, and 6
In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6.
Drug: Infliximab at weeks 0,2, and 6
Experimental: Infliximab at weeks 0,4, and 8
In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8
Drug: Infliximab at weeks 0,4, and 8
Active Comparator: Infliximab at weeks 0, and 8
In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8.
Drug: Infliximab at weeks 0 and 8
For physicians who do not feel comfortable enrolling patients in a randomized trial of infliximab re-induction they will have the option of enrolling their patients in an arm that resumes maintenance therapy only instead at 0 and 8 weeks.




Primary Outcome Measures :
  1. Failure Rate [ Time Frame: One year ]
    Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.


Secondary Outcome Measures :
  1. Short-term clinical response [ Time Frame: One year ]
    The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers.

  2. Long-term clinical response [ Time Frame: One year ]
    The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers.

  3. Short-term changes in patient Quality of Life [ Time Frame: One Year ]
    This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  4. Long-term changes in patient Quality of Life [ Time Frame: One Year ]
    This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  5. Fecal calprotectin measurements [ Time Frame: One year ]
    This will be measured by ELISA kits



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects 18 years or older who are willing and able to provide informed consent
  • HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.
  • History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.
  • Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals
  • Infliximab drug holiday for at least 12 weeks.

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent
  • Pregnant patients
  • Prior history of serious infusion reaction to IFX

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): NCT02771457


Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Lea Chen NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02771457    
Other Study ID Numbers: 15-01180
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Keywords provided by NYU Langone Health:
Influximab
IFX
Remicade
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents