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