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Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

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ClinicalTrials.gov Identifier: NCT00195715
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : January 7, 2010
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Abbott

Brief Summary:
To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: Adalimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 777 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi Center, 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 Crohn's Disease
Study Start Date : September 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab


Intervention Details:
  • Biological: Adalimumab
    Adalimumab 40 mg by subcutaneous injection every other week or every week
    Other Names:
    • ABT-D2E7
    • Humira


Primary Outcome Measures :
  1. Percentage of Subjects Achieving Clinical Remission [ Time Frame: Week 156 ]
    Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.


Secondary Outcome Measures :
  1. Percentage of Subjects Achieving Clinical Remission [ Time Frame: Week 48 ]
    Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

  2. Percentage of Subjects Achieving Clinical Remission [ Time Frame: Week 108 ]
    Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

  3. Percentage of Subjects Achieving Clinical Remission [ Time Frame: Week 204 ]
    Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

  4. Percentage of Subjects Achieving Clinical Response 100 (CR-100) [ Time Frame: Week 156 ]
    A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

  5. Percentage of Subjects Achieving Clinical Response 70 (CR-70) [ Time Frame: Week 156 ]
    A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

  6. Percentage of Subjects Achieving Steroid-free Clinical Remission [ Time Frame: Week 156 ]
    Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of <150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

  7. Percentage of Subjects Achieving Steroid-free CR-100 [ Time Frame: Week 156 ]
    Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

  8. Percentage of Subjects With Fistula Remission [ Time Frame: Week 156 ]
    Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.

  9. Percentage of Subjects With Infection [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  10. Percentage of Subjects With Serious Infection [ Time Frame: Up to 262 weeks of adalimumab treatment ]
    Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.

  11. Percentage of Subjects With Malignancy [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  12. Percentage of Subjects With Lymphoma [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  13. Percentage of Subjects With Nonmelanoma Skin Cancer [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  14. Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma) [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  15. Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer) [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  16. Percentage of Subjects With Injection Site Reaction-related Adverse Event [ Time Frame: Up to 262 weeks of adalimumab treatment ]
    An injection site reaction is any adverse event corresponding to a preferred term beginning with "injection site" excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration.

  17. Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis) [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  18. Percentage of Subjects With Congestive Heart Failure [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  19. Percentage of Subjects With Demyelinating Disease [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  20. Percentage of Subjects With Hepatic-related Adverse Event [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  21. Percentage of Subjects With Allergic Reaction-related Adverse Event [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  22. Percentage of Subjects With Lupus-like Syndrome [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  23. Percentage of Subjects With Hematologic-related Adverse Event [ Time Frame: Up to 262 weeks of adalimumab treatment ]
  24. Percentage of Subjects With Fatal Adverse Event [ Time Frame: Up to 262 weeks of adalimumab treatment ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study
  • Diagnosis of Crohn's disease
  • Willing and able to give informed consent

Exclusion Criteria:

  • Diagnosis of ulcerative colitis
  • Women cannot be pregnant or breastfeeding
  • Previous history of listeria infection or untreated tuberculosis
  • Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195715


  Show 111 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Anne Camez, MD Abbott

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Beth Tighe Associate Director, Abbott
ClinicalTrials.gov Identifier: NCT00195715     History of Changes
Other Study ID Numbers: M04-690
First Posted: September 20, 2005    Key Record Dates
Results First Posted: January 7, 2010
Last Update Posted: July 12, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents