Multi-center Acute Severe Ulcerative Colitis Cohort Study (MASCC) (MASCC)
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ClinicalTrials.gov Identifier: NCT03669822 |
Recruitment Status :
Recruiting
First Posted : September 13, 2018
Last Update Posted : December 11, 2020
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Tracking Information | |||||||||
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First Submitted Date | May 29, 2018 | ||||||||
First Posted Date | September 13, 2018 | ||||||||
Last Update Posted Date | December 11, 2020 | ||||||||
Actual Study Start Date | November 10, 2018 | ||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Inpatient response to medical management [ Time Frame: In-hospital (approximately 1-2 weeks) ] Response assessed by the following clinical care decisions based on binary outcomes: need for more than 1 dose of infliximab (yes=1 or no=0), switch in medical therapies (yes=1 or no=0), and need for surgery (yes=1 or no=0)
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
Long-term response to medical management [ Time Frame: 12 months ] Response assessed by the following clinical care decisions based on binary outcomes: need for accelerated dosing of infliximab as defined by high-dose (10mg/kg) or more than 3 doses over the first 6 weeks of therapy (yes=1 or no=0), switch in medical therapies (yes=1 or no=0), and need for surgery (yes=1 or no=0)
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Multi-center Acute Severe Ulcerative Colitis Cohort Study (MASCC) | ||||||||
Official Title | Multi-center Acute Severe Ulcerative Colitis Cohort Study (MASCC) | ||||||||
Brief Summary | Ulcerative colitis (UC) is a chronic, progressive immunologically mediated disease affecting nearly 1 million Americans. Up to one third of patients with UC will require hospitalization for severe disease (termed 'acute severe colitis (ASUC)'), often within the first year after diagnosis. Investigators will develop a large multi-center cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical and laboratory data. | ||||||||
Detailed Description | Ulcerative colitis (UC) is a chronic, progressive immunologically mediated disease affecting nearly 1 million Americans. Up to one third of patients with UC will require hospitalization for severe disease (termed 'acute severe colitis (ASUC)'), often within the first year after diagnosis. Advances in therapy for UC with the availability of effective biologics have revolutionized the medical care of UC, improving ability to achieve remission and reducing the need for colectomy for refractory disease. However, despite this general progress, investigators have not witnessed a corresponding temporal improvement in disease outcomes among those with the most severe disease. As well, providers lack the ability to 'personalize' care for UC by predicting up front which patients may develop ASUC or fail medical therapy and may benefit from early surgery, preventing protracted morbidity. Over one-third of patients with ASUC will be refractory to intravenous steroids, the cornerstone for initial management of this condition. Infliximab and cyclosporine, the two most commonly used medical rescue therapies for this cohort, have comparable short- and long-term efficacy in two randomized controlled trials. However, up to a third of patients will not respond to such medical rescue. Lack of response is poorly understood and may be multifactorial with both patient- and drug-related factors. Among the latter, those with severe disease may have greater fecal loss of infliximab resulting in lack of efficacy. Attempts to overcome this have included accelerated induction with infliximab administered up front at a higher dose (10mg/kg) or more frequent intervals. A small single center retrospective study of only 50 patients among whom 15 received accelerated induction showed reduced short-term but not long-term rates of colectomy with this approach. However, a robust and generalizable comparison of the two infliximab induction treatment strategies are lacking. A key factor limiting study of ASUC is the lack of availability of large cohorts with detailed clinical information and linked specimens. Here, investigators will develop a large multi-center cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical and laboratory data. To the investigators' knowledge, this will be the first of its kind in the United States, and will be a key resource to understand the natural history, risk stratify and optimize therapeutic algorithms for care of patients with ASUC. A sub-study with blood, stool and biopsy specimens can be utilized for translational research into mechanisms of lack of response and development of biomarkers. The infrastructure of this network will also serve as a valuable resource for clinical trials of new therapies and novel strategies, a significant unmet need. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples With DNA Description: Blood, stool, and colonic biopsies will be collected for a subgroup of participants.
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Sampling Method | Non-Probability Sample | ||||||||
Study Population | Hospitalized ulcerative colitis patients | ||||||||
Condition | Ulcerative Colitis | ||||||||
Intervention | Other: Standard of care
Care decisions driven by local physicians; this is an observational cohort.
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Study Groups/Cohorts | Inpatient ulcerative colitis patients
Patients hospitalized for acute severe ulcerative colitis will be invited to enroll. Participants will be treated at the discretion of their treating physicians per standard of care. We expect some participants will be treated with standard versus accelerated infliximab dosing, permitting comparison, in addition to other treatment strategies.
Intervention: Other: Standard of care
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
300 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 31, 2022 | ||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03669822 | ||||||||
Other Study ID Numbers | IRB00174643 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Johns Hopkins University | ||||||||
Study Sponsor | Johns Hopkins University | ||||||||
Collaborators |
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Investigators |
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PRS Account | Johns Hopkins University | ||||||||
Verification Date | December 2020 |