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Infliximab Accelerated Induction in Moderate to Severe Pediatric UC (INDUCE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209232
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Amit Assa, Schneider Children's Medical Center, Israel

Brief Summary:
Objectives: To examine the effect of accelerated infliximab induction in children with moderate to severe UC. Design: A multi-center, prospective, randomized, open label study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 17 years (Overall, 84 patients) with moderate to severe UC who are corticosteroid dependent/resistant thus planned to receive infliximab induction. Intervention: Group 1 (intervention) will receive an accelerated induction at 0,1,3 weeks (5 mg/kg) and then at week 7,11,15. Group 2 (standard) will receive a per protocol induction at 0,2,6 weeks (5 mg/kg) and then at week 14. Drug levels will be obtained prior to each infusion in each group (up to week 20). Further maintenance will be planned according to drug levels at weeks 15 and 14, respectively. Follow-up will continue without further interventions till 52 weeks following induction. Main outcome measure: Clinical remission, on infliximab at week 20. Secondary outcome measures: 1. Colectomy free rates at week 20 and 52. 2. Clinical remission on infliximab at week 52. 3. Drug levels and anti-drug antibodies prior to last study infusion. 4. Anthropometric and laboratory measures including calprotectin at the end of induction, week 20 and week 52 5. Changes in fecal microbiome, virome and bile acids content. Sample size: In order to demonstrate 30% difference in clinical remission rate between groups is significant, we will need to study 36 children in each group to be able to reject the null hypothesis that the failure rates between the groups are equal with probability (power) of 80% and a type I error probability of 0.05.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Infliximab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Infliximab Accelerated Induction for Moderate to Severe Ulcerative Colitis in Children (INDUCE) Trial
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Accelerated induction
Patients in group 1 will receive an accelerated induction of infliximab at 0,1,3 weeks (5 mg/kg) and then at week 7,11,15.
Drug: Infliximab
Accelerated induction of infliximab in moderate to severe ambulatory prdiatric UC patients

Active Comparator: Per protocol
Patients in group 2 will receive a per protocol induction of infliximab at 0,2,6 weeks (5 mg/kg) and then at week 14.
Drug: Infliximab
Accelerated induction of infliximab in moderate to severe ambulatory prdiatric UC patients




Primary Outcome Measures :
  1. Clinical remission on infliximab [ Time Frame: 20 weeks ]
    The proportion of patients treated with infliximab in complete clinical remission (PUCAI<10)


Secondary Outcome Measures :
  1. Colectomy free rate [ Time Frame: 52 weeks ]
    The proportion of patients who did not underwent surgery

  2. Clinical remission on infliximab [ Time Frame: 52 weeks ]
    The proportion of patients treated with infliximab in complete clinical remission (PUCAI<10)

  3. Drug levels prior to last study infusion [ Time Frame: 14 weeks ]
    Infliximab level (microgram per mililiter) at the end of induction

  4. Calprotectin level [ Time Frame: 20 weeks ]
    Level of fecal calprotectin (microgram per gram)

  5. Adverse events [ Time Frame: 20 weeks ]
    The rate of drug related adverse events



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ulcerative colitis
  2. PUCAI≥35
  3. Age: 6 - 17 years (inclusive)
  4. Planned to initiate IFX therapy.
  5. Naïve to biologics
  6. Informed consent
  7. Neg. PPD-Test, negative HBV- S Ag
  8. Negative stool culture, parasites and clostridium toxin

Exclusion Criteria:

  1. Pregnancy.
  2. Acute severe colitis.
  3. Renal Failure.
  4. Toxic megacolon.
  5. Patients whose disease is confined to the rectum (i.e. proctitis).
  6. Prior treatment with infliximab or adalimumab.
  7. Previous malignancy.
  8. Sepsis or active bacterial infection.
  9. Known immune deficiency.
  10. Positive Hepatitis B surface antigen or evidence for TB.
  11. IBD unclassified.

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): NCT03209232


Contacts
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Contact: Amit Assa, MD 972543522211 dr.amit.assa@gmail.com

Locations
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Israel
Schenider Children's Medical Center Recruiting
Petaẖ Tiqwa, Israel, 4920235
Contact: Amit Assa, MD    972543522211    dr.amit.assa@gmail.com   
Sponsors and Collaborators
Schneider Children's Medical Center, Israel
Investigators
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Principal Investigator: Amit Assa, MD Schneider Children's Medical Center, Israel
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Responsible Party: Amit Assa, Head of IBD program, Schneider Children's Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03209232    
Other Study ID Numbers: INDUCE
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents