Clinical trial NCT02566889: An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease
Official title: A Phase 4, Multicenter, Open-label Study of Serum Infliximab Concentrations and Efficacy and Safety of Dose Escalation in Pediatric Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Inflammatory Bowel Diseases
Keywords: Pediatric Inflammatory Bowel Disease
Infliximab
Pediatric Participants
Pediatric Ulcerative Colitis
Pediatric Crohn's Disease
Dose Escalation
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2015-10-02
Enrollment: 53
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric participants with inflammatory bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above the currently approved dose \[5 milligram (mg)/kilogram (kg) every 8 weeks (q8wk)\] and the safety of that dose escalation.

Detailed description: This is a multicenter (when more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time), open-label (all people know the identity of the intervention) study of infliximab in pediatric participants with inflammatory bowel disease. The study consists of 3 Phases: screening Phase (up to 4 weeks), open-label treatment Phase (56 weeks) and follow up safety Phase (8 weeks). The duration of participation in the study for each participant is approximately up to 68 weeks (including screening period). Participants' efficacy and safety outcomes will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Must have a biopsy-confirmed diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) prior to study entry
* Must meet concomitant medication stability criteria as specified in protocol
* Is considered eligible according to the tuberculosis (TB) Screening criteria specified in protocol
* Must have negative stool results for enteric pathogens. Stool studies must include a stool culture and Clostridium difficile toxin assay. These must have been performed during Screening or the current episode of disease exacerbation as long as the stool studies were performed within 4 months prior to the first administration of infliximab at Week 0
* Must have screening laboratory test results as specfied in the protocol
* Must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed participants prior to Screening
* Must not have discontinued infliximab therapy

Exclusion Criteria:

* Must not require, or must not have required, within the 2 months prior to Screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intraabdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from infliximab treatment
* Must not have presence or history of colonic or small bowel obstruction within 6 months prior to Screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (example, dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy)
* Must not have local manifestations of CD, such as fistulae, strictures, abscesses, or other disease complications for which surgery might be indicated. Enterocutaneuous fistulae for which surgery is not indicated, are allowed
* Must not have presence of a stoma
* Must not have documented short bowel syndrome (more than 100 centimeter in total of small bowel resected)

Primary outcomes:
measure: Clinical Response at Week 16 After Dose Escalation as Evaluated by Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn's Disease (CD) Participants
timeFrame: Week 16
measure: Clinical Response at Week 16 After Dose Escalation as Evaluated by Mayo Score in Ulcerative Colitis (UC) Participants
timeFrame: Week 16
Secondary outcomes:
measure: Sustained Clinical Response Through 56 Weeks After Dose Escalation
timeFrame: Up to Week 56
measure: Change From Baseline in Abdominal Pain and Loose/Watery Stool Frequency Sub-scores of the PCDAI at Week 16 and Week 56 in CD Participants
timeFrame: Baseline, Week 16 and Week 56
measure: Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants
timeFrame: Baseline, Week 16 and Week 56
measure: Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants
timeFrame: Baseline, Week 16 and Week 56
measure: Change From Baseline in Stool Frequency Sub-Score of the Partial Mayo Score at Week 16 and Week 56 in UC Participants
timeFrame: Baseline, Week 16 and Week 56
measure: Change From Baseline in Rectal Bleeding Sub-Scores of the Partial Mayo Score at Week 16 and Week 56 in UC Participants
timeFrame: Baseline, Week 16 and Week 56
measure: Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in UC Participants
timeFrame: Baseline, Week 16 And Week 56
measure: Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in UC Participants
timeFrame: Baseline, Week 16 And Week 56
measure: Correlation of Wong-Baker FACES Scale With Clinical Remission and Response at Week 16
timeFrame: Week 16
measure: Relationship Between Abdominal Pain PCDAI Sub-Score And the Wong-Baker Faces Scale For CD Participants
timeFrame: Week 16 and 56
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Hartford
country: United States
state: Connecticut
city: Wilmington
country: United States
state: Delaware
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Portland
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Waltham
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: