Official Title: “A Multicenter, Randomized, Double-Blind Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis”

The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Biological: adalimumab
  • Prefilled syringe, 40 mg (loading dose then every other week dosing). 80 mg at Week 0, 40 mg at Week 2 and then 40 mg every other week, Open Label at Week 8
• Biological: adalimumab
  • Prefilled syringe, 40 mg (loading dose then every other week dosing). 160 mg at Week 0, 80 mg at Week 2 and then 40 mg every other week, Open Label at Week 8
• Biological: placebo
  • Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing, Open Label at Week 8

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: adalimumab 1
• Experimental: adalimumab 2
• Placebo Comparator: Placebo

Primary Measures

• Proportion of subjects with remission
  • Time Frame: Week 8
    Safety Issue?: No

Secondary Measures

• Patient reported outcomes
  • Time Frame: Week 8 and Week 52
    Safety Issue?: No
• Clinical response indicators
  • Time Frame: Weeks 2, 4, 6, 8 and 52
    Safety Issue?: No
• Safety parameters
  • Time Frame: Throughout study
    Safety Issue?: Yes

Inclusion Criteria:

• Male or female >= 18 years of age
• Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline
• Diagnosis of active ulcerative colitis confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection
• Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

• History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis or is planning bowel surgery
• Received infliximab or any other anti-TNF agent in the past
• Current diagnosis of fulminant colitis and/or toxic megacolon
• Subjects with disease limited to the rectum (ulcerative proctitis)
• Current diagnosis of indeterminate colitis
• Current diagnosis and/or history of Crohn's disease
• Persistent chronic or active non-UC related infections requiring treatment with intravenous (iv) antibiotics, iv antivirals, or iv antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline
• History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
• If the Screening colonoscopy/flexible sigmoidoscopy shows evidence of dysplasia or a malignancy, subject may not be enrolled in the study
• Subject considered by the investigator, for any reason, to be an unsuitable candidate
• Female subject who is pregnant or breast-feeding or considering becoming pregnant

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Beverly Paperiello Study Director Abbott  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00385736

Study ID Number: M06-826

ClinicalTrials.gov Identifier: NCT00385736

Health Authority: United States: Food and Drug Administration