Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: adalimumab; placebo; adalimumab
Intervention description: At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab 40 mg eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.; At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8.; At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow. Adalimumab or placebo SC eow dosing through blinded portion of study, which continued through Week 52. While all subjects began blinded study drug (placebo or adalimumab), subjects could have switched to an OL dose of adalimumab upon disease flare or non-response at or after Week 8. In the Open-Label arm, interventions were either adalimumab 40 mg SC eow or adalimumab 40 mg SC weekly. There was no placebo intervention post Week 52.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The goal of this study was to test whether adalimumab can induce mucosal healing in subjects
      with moderate to severe ileocolonic Crohn's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Crohn's Disease for greater than 4 months.

          -  A diagnosis of ileocolonic Crohn's Disease confirmed by endoscopy or radiologic
             evaluation within 3 years of Baseline.

          -  For subjects who have had operations in the ileocolonic region of the intestine after
             documented diagnosis of ileocolonic disease, postoperative recurrence of the disease
             must be documented.

          -  Endoscopic documentation of ulceration at Screening corresponding to a score of 2 or 3
             in at least one of the five segments of the colon on the Ulcerated Surface subscore of
             the Simple Endoscopic Score for Crohn's Disease (SES-CD).

          -  Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450.

          -  Males and females >= 18 and <= 75 years of age at the Baseline visit.

          -  Adequate cardiac, renal and hepatic function as determined by the Principal
             Investigator and demonstrated by Screening laboratory evaluations, questionnaires, and
             physical examination results that do not indicate an abnormal clinical condition which
             would place the subject at undue risk and thus preclude subject participation in the
             study.

          -  Subjects must be able to self-inject study medication or have a designee or healthcare
             professional who can inject the study medication.

          -  Subjects must agree to undergo up to 4 endoscopies.

        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, human immunodeficiency virus (HIV), hepatitis B, an
             immunodeficiency syndrome, central nervous system (CNS) demyelinating disease, or
             untreated tuberculosis (TB).

          -  Subject with a current diagnosis of 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).

          -  Subject who has received any investigational biological agent in the past 3 months or
             5 half-lives prior to Baseline (whichever is longer).

          -  Subjects with a poorly controlled medical condition and any other condition which, in
             the opinion of the Investigator or the sponsor, would put the subject at risk by
             participation in the protocol.

          -  Subject who has previously used infliximab or any anti-TNF (anti tumor necrosis
             factor), even investigational, within 8 weeks of Baseline.

          -  Subject who has previously used infliximab or any anti-TNF agent and has not
             clinically responded.

          -  Previous treatment with adalimumab or previous participation in an adalimumab clinical
             study.

          -  Subjects on prednisone > 40 mg/day (or equivalent).

          -  Subjects on budesonide > 9 mg/day.

          -  Subjects with any prior exposure to Tysabri® (natalizumab).

          -  Subjects with a previous history of dysplasia of the gastrointestinal tract, or found
             to have dysplasia in any biopsy performed during the Screening endoscopy.