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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00686374
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: Adalimumab Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 1, 2008
Primary Completion Date : April 4, 2017
Study Completion Date : April 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Subjects who weigh greater than or equal to 40 kg will receive 40 mg eow or ew of adalimumab
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 408 weeks.
Other Names:
  • ABT-D2E7
  • Humira
Active Comparator: 2
Subjects who weigh less than 40 kg will receive 20 mg eow or ew of adalimumab
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 408 weeks.
Other Names:
  • ABT-D2E7
  • Humira

Outcome Measures

Primary Outcome Measures :
  1. Maintenance of Clinical Response [ Time Frame: Various timepoints up to Week 408 ]

Secondary Outcome Measures :
  1. Safety Parameters based upon patient reported outcomes and patient response indicators [ Time Frame: Throughout the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

    1. Condoms, sponge, foam, jellies, diaphragm or intrauterine device (IUD)
    2. Oral, parenteral or intravaginal contraceptives
    3. 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

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): NCT00686374

  Show 31 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Andreas Lazar AbbVie
More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00686374     History of Changes
Other Study ID Numbers: M06-807
2007-006494-90 ( EudraCT Number )
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Inflammatory Agents
Antirheumatic Agents