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An Efficacy and Safety Study of Infliximab in Pediatric Participants With Inflammatory Bowel Disease (ADAPT)

This study is currently recruiting participants.
Verified November 2017 by Janssen Scientific Affairs, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02566889
First Posted: October 2, 2015
Last Update Posted: November 17, 2017
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.
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
  Purpose
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)].

Condition Intervention Phase
Inflammatory Bowel Diseases Drug: Infliximab Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Change From Baseline in Clinical Response at Week 16 After Dose Escalation [ Time Frame: Baseline and Week 16 After Dose Escalation ]
    Clinical response is defined as, Crohn's disease (CD) participants: A decrease from baseline in Pediatric Crohn's Disease Activity Index (PCDAI) of greater than or equal to (>=) 15 points with total score of less than or equal to (<=) 30 points. Ulcerative colitis (UC) participants: A decrease from baseline in partial Mayo score of >= 2 points and >= 30 percent (%) and a decrease in the rectal bleeding sub-score by >= 1 point or achievement of an absolute sub-score of <= 1 point.


Secondary Outcome Measures:
  • Sustained Clinical Response 56 Weeks After Dose Escalation [ Time Frame: Baseline and Week 56 After Dose Escalation ]
    Sustained clinical response at Week 56 is defined as achieving clinical response per the primary endpoint definitions at Week 16 and maintaining clinical response at 1 year after dose escalation (Week 56).

  • Change From Baseline at Week 16 and at Week 56 in Abdominal Pain and Loose/Watery Stool Frequency Sub-Scores of the Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn's Disease (CD) Participants [ Time Frame: Baseline, Week 16 and Week 56 ]
    Abdominal and loose/watery stool frequency will be evaluated by using the relevant sub-scores of the PCDAI.

  • Change From Baseline at Week 16 and at Week 56 in Stool Frequency and Rectal Bleeding Sub-Scores of the Partial Mayo Score for Ulcerative Colitis (UC) Participants [ Time Frame: Baseline, Week 16 and Week 56 ]
    Stool frequency and rectal bleeding will be evaluated by using the relevant sub-scores of partial Mayo score.

  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Screening up to follow-up (8 Weeks After the Last Dose Administration of Study Drug) ]
    A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  • Changes from baseline at Week 16 and at Week 56 in Abdominal pain using the Wong-Baker FACES scale in CD Participants [ Time Frame: Baseline, Week 16 and Week 56 ]
    The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3.

  • Changes from Baseline at Week 16 and at Week 56 in Absolute stool frequency in CD Participants [ Time Frame: Baseline, Week 16 and Week 56 ]
  • Changes from Baseline at Week 16 and at Week 56 in Abdominal Pain Using the Wong-Baker FACES scale for UC Participants [ Time Frame: Baseline, Week 16 and Week 56 ]
    The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3.

  • Changes from Baseline at Week 16 and at Week 56 in Absolute stool frequency in UC Participants [ Time Frame: Baseline, Week 16 and Week 56 ]
  • Percentage of Participants who Achieved Clinical Response at Week 16 as assessed by Wong-Baker FACES Pain Scale [ Time Frame: Week 16 ]
    The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3.4 The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst".

  • Percentage of Participants who Achieved Clinical Remission at Week 16 as assessed by Wong-Baker FACES Pain Scale [ Time Frame: Week 16 ]
    The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3.4 The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst".


Estimated Enrollment: 130
Actual Study Start Date: November 12, 2015
Estimated Study Completion Date: August 6, 2030
Estimated Primary Completion Date: August 6, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation Group
Participants must have completed the recommended infliximab induction dosing regimen of 5 milligram (mg)/kilogram (kg) at weeks 0, 2, and 6, followed by at least 1 maintenance doses of 5 mg/kg every 8 weeks (q8wk).
Drug: Infliximab
Participants in the dose escalation group will escalate dose from infliximab 5 mg/kg q8w to 10 mg/kg q8w at the time of loss response. Participants in the reference group will be maintained on infliximab 5 mg/kg q8w.
Other Name: Remicade
Experimental: Reference Group
Participants must have completed the recommended infliximab induction dosing regimen of 5 mg/kg at weeks 0, 2, and 6, and have maintained a stable clinical response to infliximab after at least 1 maintenance doses of 5 mg/kg q8wk.
Drug: Infliximab
Participants in the dose escalation group will escalate dose from infliximab 5 mg/kg q8w to 10 mg/kg q8w at the time of loss response. Participants in the reference group will be maintained on infliximab 5 mg/kg q8w.
Other Name: Remicade

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 (2 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 66 Weeks (including screening period). Participants' efficacy and safety outcomes will be monitored throughout the study.
  Eligibility

Information from the National Library of Medicine

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:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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)
  Contacts and Locations
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): NCT02566889


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Hide Study Locations
Locations
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
United States, California
Children's Hospital Suspended
Los Angeles, California, United States, 90027
University Of California Recruiting
San Francisco, California, United States, 94158
Stanford/Lucille Packard Children's Hospital Withdrawn
Stanford, California, United States, 94304
United States, Connecticut
Connecticut Childrens Medical Center Recruiting
Hartford, Connecticut, United States, 06106
United States, Delaware
Nemours DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Children's Center For Digestive Healthcare, Llc Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61602
United States, Indiana
Riley Children's Hospital Recruiting
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Willis-Knighton Physician Network Recruiting
Shreveport, Louisiana, United States, 71118
United States, Maine
Maine Medical Center Pediatric Specialty Group Recruiting
Portland, Maine, United States, 04102
United States, Maryland
University of Maryland School of Medicine Not yet recruiting
Baltimore, Maryland, United States, 21201
The Johns Hopkins Children's Center Recruiting
Baltimore, Maryland, United States, 21287-2631
United States, Massachusetts
Floating Hospital For Children at Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Mass General Hospital Recruiting
Waltham, Massachusetts, United States, 2451
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Minnesota Gastro Associates Completed
Saint Paul, Minnesota, United States, 55114
United States, Missouri
The Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
United States, New Hampshire
Dartmouth Hitchcock Not yet recruiting
Lebanon, New Hampshire, United States, 03765
United States, New York
University Pediatric Associates Inc. Withdrawn
Buffalo, New York, United States, 14201
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects Recruiting
New York, New York, United States, 10029
CUMC & Morgan Stanely Children's Hosp Recruiting
New York, New York, United States, 10032
Ny Presbyterian Weill Cornell Recruiting
New York, New York, United States, 10065
Stony Brook University Medical Center Not yet recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599-7229
Duke University Medical Center Withdrawn
Durham, North Carolina, United States, 27713
United States, Ohio
Cincinnati Children's Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital Withdrawn
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Penn State Hershey Children's Hospital Withdrawn
Hershey, Pennsylvania, United States, 17033
Childrens Hospital Of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Brown SOM, Hasbro Children's Hospital Withdrawn
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9063
Cook Childrens Medical Center Recruiting
Fort Worth, Texas, United States, 76104
United States, Virginia
Pediatric Specialists Of Virginia Recruiting
Fairfax, Virginia, United States, 22031
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53792-4108
Medical College Of Wisconsin Withdrawn
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Nova Scotia
Iwk Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Children's Hospital of Western Ontario Recruiting
London, Ontario, Canada, N6A 5W9
Hospital For Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier Sainte Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
CIUSSS de L'Estrie - CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

Additional Information:
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT02566889     History of Changes
Other Study ID Numbers: CR108044
C0168IBD4020 ( Other Identifier: Janssen Scientific Affairs, LLC )
2015-001653-32 ( EudraCT Number )
First Submitted: October 1, 2015
First Posted: October 2, 2015
Last Update Posted: November 17, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Scientific Affairs, LLC:
Pediatric Inflammatory Bowel Disease
Infliximab
Pediatric Participants
Pediatric Ulcerative Colitis
Pediatric Crohn's Disease
Dose Escalation

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents