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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, July 2008

Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00408629
  Purpose

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-TNF monoclonal antibody adalimumab 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   

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 and Maintenance 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 achieving clinical remission at defined time points [ Time Frame: Week 8 and Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient reported outcomes [ Time Frame: Week 8, Week 32 and Week 52 ] [ Designated as safety issue: No ]
  • Clinical response indicators [ Time Frame: Week 8, Week 32 and Week 52 ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: Week 8, Week 32 and Week 52 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   500
Study Start Date:   December 2006
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
adalimumab group: Experimental Biological: adalimumab
Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 52.
placebo group: Experimental Biological: placebo
Matching Placebo for prefilled syringe, 40 mg,

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

Criteria

Inclusion Criteria:

  • Subjects >=18 years of age and in good health (Investigator discretion) with a recent stable medical history
  • 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
  • Active ulcerative colitis that is poorly controlled despite concurrent treatment with oral corticosteroids and/or immunosuppressants as defined below:

    • Stable (± 5 mg) corticosteroid dose (prednisone >= 20 mg/day or equivalent) for at least 14 days prior to Baseline or maintenance, corticosteroid dose (prednisone < 20 mg/day or equivalent) for at least 40 days prior to Baseline
    • At least a 90 day course of azathioprine or 6-MP prior to Baseline, with a dose of azathioprine >= 1.5 mg/kg/day or 6-MP >= 1 mg/kg/day (rounded to the nearest available tablet formulation), or a dose that is the highest tolerated by the subject (e.g., due to leukopenia, elevated liver enzymes, nausea) during that time. Subject must be on a stable dose for at least 28 days prior to Baseline
  • Concurrent therapy will not be required for subjects who were previously treated with corticosteroids or immunosuppressants (azathioprine or 6-MP) during the past 5 years and in the judgment of the investigator have failed to respond to or could not tolerate their treatment.
  • Subjects may be included if they have previously used an anti-TNF agent (except adalimumab) and discontinued its use due to a loss of response or intolerance to the agent
  • 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 previous treatment with adalimumab or previous participation in an adalimumab clinical study
  • Current diagnosis of fulminant colitis and/or toxic megacolon
  • Subject with disease limited to the rectum (ulcerative proctitis)
  • Current diagnosis of indeterminate colitis
  • Current diagnosis and/or history of Crohn's disease
  • Currently receiving total parenteral nutrition (TPN)
  • Subject using aminosalicylates for less than 90 days prior to Baseline or not on a stable dose for at least 28 days prior to Baseline or discontinued use within 28 days of Baseline
  • Subject who has previously used infliximab or any anti-TNF agent within 56 days of Baseline
  • Subject who has previously used infliximab or any anti-TNF agent and has not clinically responded at any time ("primary non-responder") unless subject experienced a treatment limiting reaction
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study
  • Subject with any prior exposure to Tysabri® (natalizumab)
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate
  • Subject currently taking both budesonide and prednisone (or equivalent) simultaneously
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408629

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

Show 116 study locations  Show 116 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:   M06-827, EUDRACT: 2006-002782-40
First Received:   December 5, 2006
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00408629
Health Authority:   United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 22, 2008




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