Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adalimumab
Intervention description: Participants who enrolled into the study from blinded therapy in Study M06-806 received open-label (OL) therapy at a dose dependent on their body weight. Participants weighing ≥ 40 kg received 40 mg of adalimumab every other week (eow), and those who weighed < 40 kg received 20 mg of adalimumab eow. Starting at Week 8, participants who had a disease flare may have been switched to every week (ew) treatment at the same dose of adalimumab received while on eow treatment. Participants who enrolled from OL therapy in Study M06-806 continued to receive the same dose they were receiving (i.e., 40 mg ew or 20 mg ew) at the Week 52 visit of Study M06-806. Adalimumab dose could have been decreased to the next lower treatment level for those with body weight changes. Participants who responded to treatment may have also had their dosage frequency decreased from ew to eow dosing, as well as a decrease in dosage.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 7 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's Disease; adalimumab

Summary:

      This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody
      adalimumab as an effective therapy for maintaining clinical response in pediatric
      participants with Crohn's disease (CD) and to gather long-term safety and tolerability data
      in this population. Participants were allowed to enroll in the study if they participated in
      and successfully completed Study M06-806 (NCT00409682) through Week 52.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have successfully enrolled in and completed Study M06-806 through
             Week 52.

          -  Participant must have been a responder at any time point during the M06-806 study
             (defined as having achieved at least a 15-point reduction in the Pediatric Crohn's
             Disease Activity Index (PCDAI) from Baseline).

          -  If female, participants who were sexually active and of child-bearing potential were
             to 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
             included the following:

               1. Condoms, sponge, foam, jellies, diaphragm or intrauterine device (IUD)

               2. Oral, parenteral or intravaginal contraceptives

               3. A vasectomized partner

          -  Participant of legal age, parent or legal guardian, as required, voluntarily signed
             and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
             approved informed consent form, after the nature of the study was explained and the
             participant of legal age, participant's parent, or legal guardian, as required, had
             the opportunity to ask questions. Participants were to be included in all discussions,
             and if required, their signature on an assent form was to be obtained.

          -  Parent or legal guardian of participant who was not of legal age, as required, must
             have been willing to actively supervise storage and administration of study drug and
             to ensure that the time of each dose was accurately recorded in the participant's
             diary.

          -  Participants of legal age, must have been willing to actively store, administer, and
             accurately record study drug administration in the participant diary.

          -  Participant was 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 participant was considered by the Investigator to be an unsuitable
             candidate for continuing therapy in the M06-807 study.

          -  Participant had abnormal laboratory or other test results that in the opinion of the
             Investigator would make the participant 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 were
             exclusionary.

          -  Participant with known, symptomatic obstructive strictures.

          -  Participant who was planning surgical bowel resection at any time point while enrolled
             in the study.

          -  Participant who had short bowel syndrome as determined by the Investigator.

          -  Participant who was receiving total parenteral nutrition (TPN).

          -  Participant who was unwilling to discontinue growth hormone prior to the first dose of
             open-label study drug at the Baseline visit of M06-807.

          -  Female participant who was pregnant or currently breastfeeding.

          -  Participant with a history of clinically significant drug or alcohol abuse in the last
             year.

          -  Participant 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, would put the participant at risk by participation
             in the protocol.

          -  Participant with any prior exposure to Tysabri (natalizumab).

          -  Participant with a known hypersensitivity to the excipients of adalimumab as stated in
             the label.

          -  Participant with a previous history of dysplasia of the gastrointestinal tract.