Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00686374
First received: May 27, 2008
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806.


Condition Intervention Phase
Crohn's Disease
Biological: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label Study of the Human Anti−TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Maintenance of Clinical Remission [ Time Frame: Various timepoints up to Week 264 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Parameters based upon patient reported outcomes and patient response indicators [ Time Frame: Various timepoints up to Week 264 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2008
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Heavier population, greater than or equal to 40kg, will receive 40mg
Biological: Adalimumab
Pre-filled syringe, 40mg (subjects >or =40kg) /20mg EOW (subjects <40kg)or 40mg(subjects >or =40kg)/20mg EW(subjects <40kg) for up to 264 weeks.
Other Name: ABT-D2E7 Humira
Active Comparator: 2
Lighter population, less than 40kg, will receive 20mg
Biological: Adalimumab
Pre-filled syringe, 40mg (subjects >or =40kg) /20mg EOW (subjects <40kg)or 40mg(subjects >or =40kg)/20mg EW(subjects <40kg) for up to 264 weeks.
Other Name: ABT-D2E7 Humira

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have successfully enrolled in and completed Protocol M06-806 through Week 52.
  • Subject must be a responder at any time point during the M06-806 study.
  • If female, subjects who are sexually active and are of child-bearing potential should be practicing an approved method of birth control throughout the study and for 150 days after study drug administration. Examples of approved methods of birth control include the following:

    • Condoms, sponge, foam, jellies, diaphragm or intrauterine device (IUD)
    • Oral, parenteral or intravaginal contraceptives
    • A vasectomized partner
  • Subject of legal age, parent or legal guardian, as required, has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form, after the nature of the study has been explained and the subject of legal age, subject's parent, or legal guardian, as required, has had the opportunity to ask questions. Subjects will be included in all discussions, and if required, their signature on an assent form will be obtained.
  • Parent or legal guardian of subject who is not of legal age, as required, 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.
  • If a subject of legal age, must be willing to actively store, administer, and accurately record study drug administration in the subject diary.
  • Subject is judged to be in acceptable medical condition, as determined by the Principal Investigator based upon results of clinical and laboratory evaluations done throughout the preceding Crohn's disease study M06-806.

Exclusion Criteria:

  • For any reason, the subject is considered by the Investigator to be an unsuitable candidate for continuing therapy in the M06-807 study.
  • Subject has abnormal laboratory or other test results that in the opinion of the Investigator will make the subject unsuitable to participate in this study.
  • 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 listeriosis, histoplasmosis, chronic or active hepatitis B infection, human immunodeficiency virus (HIV) infection, any immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB (receiving treatment or not receiving treatment). Ongoing severe infections such as sepsis and opportunistic infections will be exclusionary.
  • Subject with known, symptomatic obstructive strictures.
  • Subject who is planning surgical bowel resection at any time point while enrolled in the study.
  • Subject who has short bowel syndrome as determined by the Investigator.
  • Subject who is currently receiving total parenteral nutrition (TPN).
  • Subject who is unwilling to discontinue growth hormone prior to the first dose of open-label study drug at the Baseline visit of M06-807.
  • Female subject who is pregnant or currently breast-feeding.
  • Subject with a history of clinically significant drug or alcohol abuse in the last year.
  • Subject with a poorly controlled medical condition such as: uncontrolled diabetes, recurrent infections, unstable ischemic heart disease, moderate to severe heart failure, recent cerebrovascular accidents or any other condition which, in the opinion of the Investigator or the Sponsor, will put the subject at risk by participation in the protocol.
  • Subject with any prior exposure to Tysabri (natalizumab).
  • Subject with a known hypersensitivity to the excipients of adalimumab as stated in the label.
  • Subject with a previous history of dysplasia of the gastrointestinal tract.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686374

  Show 30 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Roopal Thakkar AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00686374     History of Changes
Other Study ID Numbers: M06-807, 2007-006494-90
Study First Received: May 27, 2008
Last Updated: October 8, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by AbbVie:
adalimumab
Crohn's Disease

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

ClinicalTrials.gov processed this record on October 20, 2014