Ulcerative ColitisPhase 3NCT00573794
Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
A Phase 3 study testing adalimumab in people with Ulcerative Colitis, run by AbbVie (prior sponsor, Abbott).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2007to Dec 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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).
- Conditions
- Ulcerative Colitis
- Being tested
- adalimumab
- Keywords
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabBiological
Also called ABT-D2E7, HUMIRA
adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab 40 mg EOW/EW | Experimental | 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. Receives: Biological: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Mayo Score: Change From Baseline Over Time
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.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Mayo Score: Change From Baseline Over Time
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.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Secondary outcomes (23)
Percentage of Participants With Remission Per Partial Mayo Score Over Time
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.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Mayo Endoscopy Subscore: Change From Baseline Over Time
The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time
The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement.
Measured: 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
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.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Mayo Stool Frequency Subscore: Change From Baseline Over Time
The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
WPAI:GH Impairment While Working: Change From Baseline Over Time
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.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
WPAI:GH Overall Work Impairment: Change From Baseline Over Time
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.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
WPAI:GH Activity Impairment: Change From Baseline Over Time
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.
Measured: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Colectomy Rate
The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.
Measured: 5 years
Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations
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.
Measured: 5 years
Number of Participants With Adverse Events
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.
Measured: 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
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Measured: Baseline (Week 0), final value (up to 5 years)
Hematology: Mean Change From Baseline to Final Values in Hematocrit
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Measured: Baseline (Week 0), final value (up to 5 years)
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
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Measured: 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
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Measured: 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
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Measured: 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
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Measured: Baseline (Week 0), final value (up to 5 years)
Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Measured: Baseline (Week 0), final value (up to 5 years)
Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Measured: Baseline (Week 0), final value (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study start28 Nov 2007
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573794
- Sponsor's protocol ID
- M10-223
- Other IDs
- 2007-004157-28
- Status last verified
- Jul 2021
- First submitted
- 12 Dec 2007
- Last updated
- 7 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 25155227Ryan 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.
PubMed 29380251
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00573794
- Acronym / sponsor ID
- M10-223
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2007 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 19 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab 40 mg EOW/EW | Experimental | Biological: adalimumabOpen-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumabAlso: ABT-D2E7, HUMIRAadalimumab prefilled syringes administered as subcutaneous injection EW or EOW | Biological | Adalimumab 40 mg EOW/EW |
Primary outcome
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.
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.
23 secondary outcomes
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
Mayo Endoscopy Subscore: Change From Baseline Over Time
Time frame: 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
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
Mayo Stool Frequency Subscore: Change From Baseline Over Time
Time frame: 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
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
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
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
WPAI:GH Impairment While Working: Change From Baseline Over Time
Time frame: 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
WPAI:GH Activity Impairment: Change From Baseline Over Time
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Colectomy Rate
Time frame: 5 years
Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations
Time frame: 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)
Hematology: Mean Change From Baseline to Final Values in Hemoglobin
Time frame: 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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25155227Colombel 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.
- Derived from this study: PubMed 29380251Ryan 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.
- Related Info.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab in people with Ulcerative Colitis, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial Mayo Score: Change From Baseline Over Time (time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00573794, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.