Text Size

Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00573794
First received: December 12, 2007
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis


Condition Intervention Phase
Ulcerative Colitis
 Biological: adalimumab
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change from Baseline in Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]
  • Change from Baseline in Partial Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in IBDQ & SF-36 [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]
  • Change from Baseline in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]
  • AEs, Laboratory data, physical exams, and vital signs [ Time Frame: Throughout course of the study ] [ Designated as safety issue: No ]
  • Cumulative number of unscheduled outpatient visits [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 mg EOW or 40 mg weekly Biological: adalimumab
Prefilled syringes 40 mg EOW subcutaneous and prefilled syringes 40 mg weekly subcutaneous
Other Names:
  • ABT-D2E7
  • Humira

  Eligibility

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

Inclusion Criteria:

  • Subject must have successfully enrolled and completed either the M06-826 study or the M06-827 study
  • Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

  • Subject has not responded to weekly adalimumab therapy in M06-826 or M06-827
  • 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: NCT00573794

  Show 133 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Andreas Lazar, MD AbbVie
  More Information

Additional Information:
This Clinical Study maybe evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00573794     History of Changes
Other Study ID Numbers: M10-223, 2007-004157-28
Study First Received: December 12, 2007
Last Updated: April 8, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria : Federal Ministry for Labour, Health, and Social Affairs
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Medsafe
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
United States: Food and Drug Administration

Keywords provided by AbbVie:
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Adalimumab
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 13, 2013