Infliximab Accelerated Induction in Moderate to Severe Pediatric UC

NCT03209232 | Terminated DMC

• 1 other identifier: INDUCE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical remission on infliximab

  The proportion of patients treated with infliximab in complete clinical remission (PUCAI\<10)

  20 weeks

Secondary Outcomes (5)

• Colectomy free rate

  52 weeks

• Clinical remission on infliximab

  52 weeks

• Drug levels prior to last study infusion

  14 weeks

• Calprotectin level

  20 weeks

• Adverse events

  20 weeks

Study Arms (2)

Accelerated induction

EXPERIMENTAL

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

Per protocol

ACTIVE COMPARATOR

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

Interventions

Infliximab DRUG

Accelerated induction of infliximab in moderate to severe ambulatory prdiatric UC patients

Accelerated induction; Per protocol

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnancy.
• Acute severe colitis.
• Renal Failure.
• Toxic megacolon.
• Patients whose disease is confined to the rectum (i.e. proctitis).
• Prior treatment with infliximab or adalimumab.
• Previous malignancy.
• Sepsis or active bacterial infection.
• Known immune deficiency.
• Positive Hepatitis B surface antigen or evidence for TB.
• IBD unclassified.

Sponsors & Collaborators

• Schneider Children's Medical Center, Israel: lead

Study Sites (1)

Schenider Children's Medical Center

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Amit Assa, MD

  Schneider Children's Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of IBD program

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: July 6, 2017
• Study Start: April 16, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)