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

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ClinicalTrials.gov Identifier: NCT00573794
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : December 19, 2017
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Biological: adalimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 592 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : November 28, 2007
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Adalimumab 40 mg EOW/EW
Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Biological: adalimumab
adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
Other Names:
  • ABT-D2E7
  • HUMIRA



Primary Outcome Measures :
  1. Partial Mayo Score: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.

  2. Mayo Score: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.


Secondary Outcome Measures :
  1. Percentage of Participants With Remission Per Partial Mayo Score Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). Remission was defined as Partial Mayo score ≤ 2 with no subscore > 1.

  2. Mayo Endoscopy Subscore: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement.

  3. Mayo Rectal Bleeding Subscore: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement.

  4. Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The Mayo Physician's Global Assessment of Disease Severity subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Physician's Global Assessment of Disease Severity subscore indicates improvement.

  5. Mayo Stool Frequency Subscore: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement.

  6. Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The IBDQ is a 32-item questionnaire that assesses how the subject felt during the 2 weeks before the measurement time point. Questions are related to symptoms the subject might have had as a result of UC, how the subject felt in general, how the subject's mood was, and social and work problems the subject might have that resulted from UC. An increase in IBDQ score indicates less impact of UC on the subject's life. The responses to each question range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).

  7. 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.

  8. 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.

  9. Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.

  10. WPAI:GH Impairment While Working: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.

  11. WPAI:GH Overall Work Impairment: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.

  12. WPAI:GH Activity Impairment: Change From Baseline Over Time [ Time Frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 ]
    The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.

  13. Colectomy Rate [ Time Frame: 5 years ]
    The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.

  14. Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations [ Time Frame: 5 years ]
    The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to ulcerative colitis since the last visit. The cumulative number of unscheduled utilizations over the course of the study is presented.

  15. Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks) ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

  16. Hematology: Mean Change From Baseline to Final Values in Hemoglobin [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

  17. Hematology: Mean Change From Baseline to Final Values in Hematocrit [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

  18. Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

  19. Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

  20. Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

  21. Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

  22. Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

  23. Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein [ Time Frame: Baseline (Week 0), final value (up to 5 years) ]
    Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have successfully enrolled and completed either study M06-826 (NCT00385736) or study M06-827 (NCT00408629)
  • 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 (NCT00385736) or M06-827 (NCT00408629)
  • 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

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): NCT00573794


Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: AbbVie Inc AbbVie

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00573794     History of Changes
Other Study ID Numbers: M10-223
2007-004157-28 ( EudraCT Number )
First Posted: December 14, 2007    Key Record Dates
Results First Posted: December 19, 2017
Last Update Posted: February 20, 2018
Last Verified: January 2018

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Ulcerative Colitis

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