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Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis
This study is currently recruiting participants.
Verified by Abbott, November 2008
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00385736
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Biological: adalimumab
Biological: placebo
Phase III

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Ulcerative Colitis
Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of subjects with remission [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient reported outcomes [ Time Frame: Week 8 and Week 52 ] [ Designated as safety issue: No ]
  • Clinical response indicators [ Time Frame: Weeks 2, 4, 6, 8 and 52 ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 375
Study Start Date: November 2006
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
adalimumab 1: Experimental 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
adalimumab 2: Experimental 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
Placebo: Placebo Comparator Biological: placebo
Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing, Open Label at Week 8

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385736

Contacts
Contact: Global Medical Information- Abbott 1-800-633-9110 medinfo@abbott.com

  Show 96 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly Paperiello Abbott
  More Information

Responsible Party: Abbott ( Beverly Paperiello, Director, Immunology Clinical Program Management )
Study ID Numbers: M06-826, EudraCT : 2006-002781-20
Study First Received: October 9, 2006
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00385736  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Adalimumab
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Gastroenteritis
Colitis
Immunoglobulins

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Pathologic Processes
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009