An Open-Label Study of Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00409617

Purpose

The objectives of this study are to further evaluate and delineate the safety and efficacy profile of adalimumab when administered to subjects with moderate to severe Crohn's Disease.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

The Harvey Bradshaw Index [ Time Frame: Ongoing through entire study ] [ Designated as safety issue: No ]
Counts of the number of draining cutaneous fistulas. [ Time Frame: Ongoing through entire study ] [ Designated as safety issue: No ]
Assessment on progression of extra-intestinal disease-related manifestations on physical exam. [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient reported outcomes [ Time Frame: Ongoing through entire study ] [ Designated as safety issue: No ]
Clinical response indicators [ Time Frame: Ongoing through entire study ] [ Designated as safety issue: No ]
Safety Parameters [ Time Frame: Ongoing through entire study ] [ Designated as safety issue: No ]

Enrollment:	1000
Study Start Date:	December 2006
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Label: Experimental	Biological: adalimumab Adalimumab 40 mg Every Other Week Dosing Biological: adalimumab Adalimumab 40 mg Every Week Dosing if subject's meet criteria.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of moderate to severe Crohn's Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months (16 weeks)
Inadequate response to conventional therapy for Crohn's Disease
Subjects >=18 and <=75 years of age and in good health (Investigator discretion) with a recent stable medical history

Exclusion Criteria:

Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
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
Female subject who is pregnant or breast-feeding or considering becoming pregnant
Previous treatment with adalimumab or previous participation in an adalimumab clinical study
Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Subjects with any prior exposure to Tysabri® (natalizumab)
Subjects on prednisone >40 mg/day (or equivalent), subjects on budesonide >9 mg/day, or subjects who are taking prednisone and budesonide concurrently at Baseline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409617

Show 219 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Beverly Paperiello

Abbott

More Information

No publications provided

Responsible Party:	Abbott Laboratories ( Barry Bittle )
Study ID Numbers:	M06-829, EudraCT:2006-002078-23
Study First Received:	December 8, 2006
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00409617 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety

Study placed in the following topic categories:

Anti-Inflammatory Agents
Crohn's Disease
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab

Ileal Diseases
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Crohn Disease
Antirheumatic Agents
Gastroenteritis
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab

Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Gastroenteritis
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 01, 2009