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Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon
This study has been completed.
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00348283
  Purpose

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


Condition Intervention Phase
Crohn's Disease
Biological: adalimumab
Biological: placebo
Phase III

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Crohn's Disease Endoscopy
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 Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Presence of absence of mucosal ulceration by endoscopy relative to Screening endoscopy [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects without mucosal ulceration on endoscopy relative to Screening endoscopy [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Parameters [ Time Frame: Week 52 and in long term extension ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes [ Time Frame: Week 52 and in long term extension ] [ Designated as safety issue: No ]
  • Clinical response indicators [ Time Frame: Week 52 and in long term extension ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: August 2006
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Double Blind: Placebo Comparator
Blinded study through Week 52. Adalimumab compared to Placebo during blinded portion.
Biological: adalimumab
Adalimumab 40 mg Every Other Week Dosing through blinded portion of study, which continues through Week 52. Subjects may be switched to open-label every other week or open-label every week dosing to treat disease flare or non-response.
Biological: placebo
Placebo Every Other Week Dosing through blinded portion of study, which continues through Week 52. Subjects may be switched to open-label every other week or open-label every week dosing to treat disease flare or non-response.
Open Label
Note: No comparator is used in Open Label portion of study. Open Label begins post Week 52
Biological: adalimumab
Open Label begins post Week 52, interventions will be dosed in two different manners: 40 mg every other week or 40 mg weekly. There is no Placebo intervention post Week 52.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348283

  Show 21 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly A Paperiello Abbott
  More Information

Responsible Party: Abbott ( Barry Bittle )
Study ID Numbers: M05-769
Study First Received: June 30, 2006
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00348283  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases
Adalimumab
Gastroenteritis
Intestinal Diseases
Immunoglobulins

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

ClinicalTrials.gov processed this record on January 14, 2009