- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00573794
Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
July 2, 2021 updated by: AbbVie (prior sponsor, Abbott)
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
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
592
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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).
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
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.
|
Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
|
Colectomy Rate
Time Frame: 5 years
|
The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.
|
5 years
|
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.
|
5 years
|
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.
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From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks)
|
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.
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Baseline (Week 0), final value (up to 5 years)
|
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.
|
Baseline (Week 0), final value (up to 5 years)
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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.
|
Baseline (Week 0), final value (up to 5 years)
|
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.
|
Baseline (Week 0), final value (up to 5 years)
|
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.
|
Baseline (Week 0), final value (up to 5 years)
|
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.
|
Baseline (Week 0), final value (up to 5 years)
|
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.
|
Baseline (Week 0), final value (up to 5 years)
|
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.
|
Baseline (Week 0), final value (up to 5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Colombel JF, Sandborn WJ, Ghosh S, Wolf DC, Panaccione R, Feagan B, Reinisch W, Robinson AM, Lazar A, Kron M, Huang B, Skup M, Thakkar RB. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: Data from ULTRA 1, 2, and 3. Am J Gastroenterol. 2014 Nov;109(11):1771-80. doi: 10.1038/ajg.2014.242. Epub 2014 Aug 26.
- Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 28, 2007
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
December 12, 2007
First Submitted That Met QC Criteria
December 12, 2007
First Posted (ESTIMATE)
December 14, 2007
Study Record Updates
Last Update Posted (ACTUAL)
July 7, 2021
Last Update Submitted That Met QC Criteria
July 2, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10-223
- 2007-004157-28 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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