Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
This study is currently recruiting participants.
Verified by Abbott, April 2009
First Received: December 8, 2006   Last Updated: April 10, 2009   History of Changes
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00409682
  Purpose

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease


Condition Intervention Phase
Crohn's Disease
Biological: adalimumab
Phase III

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Multi-Center, Randomized, Double-Blinded, Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Rate of clinical remission as defined by PCDAI score [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Parameters [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • Clinical Response Indicators [ Time Frame: Entire Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 184
Study Start Date: April 2007
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Heavier comparator: Active Comparator
Subjects whose weight is >= 40 kg
Biological: adalimumab
Adalimumab 160 mg and 80 mg at Weeks 0 and 2 if subject is greater than or equal to 40 kg; if a subject is < 40 kg they will receive 80 mg and 40 mg at Weeks 0 and 2.
Biological: adalimumab
One of two maintenance groups ( low-dose or high-dose); Week 4 subjects stratified by weight: adalimumab 40 mg EOW (weight greater than or equal to 40 kg); or 20 mg adalimumab EOW (if weight is < 40 kg); low-dose group will receive: 20 mg adalimumab EOW if weight is greater than or equal to 40 kg or 10 mg adalimumab EOW if weight is > 40 kg.
Biological: adalimumab
Weekly dosing of adalimumab: 20 mg for subjects less than 40 kg and 40 mg for subjects who are greater than or equal to 40 kg.
Lighter comparator: Active Comparator
Subjects whose weight is < 40 mg
Biological: adalimumab
Adalimumab 160 mg and 80 mg at Weeks 0 and 2 if subject is greater than or equal to 40 kg; if a subject is < 40 kg they will receive 80 mg and 40 mg at Weeks 0 and 2.
Biological: adalimumab
One of two maintenance groups ( low-dose or high-dose); Week 4 subjects stratified by weight: adalimumab 40 mg EOW (weight greater than or equal to 40 kg); or 20 mg adalimumab EOW (if weight is < 40 kg); low-dose group will receive: 20 mg adalimumab EOW if weight is greater than or equal to 40 kg or 10 mg adalimumab EOW if weight is > 40 kg.
Biological: adalimumab
Weekly dosing of adalimumab: 20 mg for subjects less than 40 kg and 40 mg for subjects who are greater than or equal to 40 kg.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects between the ages of 6 and 17, inclusive, prior to baseline dosing.
  • Subjects with a diagnosis of Crohn's disease for greater than 12 weeks prior to screening, confirmed by endoscopy or radiologic evaluation.
  • Subjects with a PCDAI score of > 30.
  • Parent or guardian has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC).
  • Parent or legal guardian must be willing to actively supervise storage and administration of study drug and to ensure that the time of each dose is accurately recorded in the subject's diary
  • Adequate cardiac, renal and hepatic function as determined by principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits.
  • Subjects may have previously received infliximab, providing the subject had an initial response and then discontinued use due to a loss of response, or discontinued use due to intolerance.

Exclusion Criteria:

  • History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma-in-situ of the cervix.
  • History of listeria, histoplasmosis, chronic or active hepatitis B infection, human immunodeficiency virus (HIV), an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease, or active TB (receiving treatment or not receiving treatment), severe infections such as sepsis and opportunistic infections.
  • Subject with infectious colitis, ulcerative colitis or indeterminate colitis as determined by the investigator and Abbott Medical Monitor.
  • Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
  • Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
  • Subjects with any prior exposure to Tysabri (natalizumab).
  • Subject who has previously used infliximab within eight weeks of Baseline.
  • Subjects who have previously used infliximab and have not clinically responded at any time ("primary non-responder" are not allowed).
  • Subject who received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
  • Subjects with a poorly controlled medical condition such as:

    • Uncontrolled diabetes mellitus
    • Moderate to severe heart failure
    • Recent cerebrovascular accidents
    • Any other condition which, in the opinion of the investigator or the sponsor, would put the subject at risk by participation in the protocol.
  • Subjects currently taking both budesonide and prednisone (or equivalent).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409682

Contacts
Contact: Barry Bittle 973-394-5477 barry.bittle@abbott.com

  Show 65 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly A Paperiello Abbott
  More Information

No publications provided

Responsible Party: Abbott ( Barry Bittle )
Study ID Numbers: M06-806
Study First Received: December 8, 2006
Last Updated: April 10, 2009
ClinicalTrials.gov Identifier: NCT00409682     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Anti-Inflammatory Agents
Crohn's Disease
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab
Ileal Diseases
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Crohn Disease
Antirheumatic Agents
Gastroenteritis
Immunoglobulins

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab
Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Gastroenteritis
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009