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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 : May 27, 2020
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Maryland, College Park
University of North Carolina, Chapel Hill
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date May 29, 2018
First Posted Date September 13, 2018
Last Update Posted Date May 27, 2020
Actual Study Start Date November 10, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2018)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 11, 2018)
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)
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.
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.
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 11, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients 18-80 years
  • UC or IBD-unspecified (IBDU) diagnosed according to standard criteria
  • Active disease defined as Simple Clinical Colitis Activity Index > 2 (day/night bowel frequency, urgency with defecation, blood in stool, general well-being, and extracolonic features)
  • Admitted to the hospital
  • Initiating intravenous corticosteroid therapy or medical rescue therapy

Exclusion Criteria:

  • Patients with quiescent disease
  • Inability to provide informed consent
  • Prior colitis related surgery including J-pouch or stoma
  • Non-IBD related hospital admission
  • Women who are pregnant (from the specimen substudy only)
  • Non - English speaking
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Joanna MP Melia, MD 4109554916 jpeloqu2@jhmi.edu
Contact: Kimberly Baytops, MS 4106143816 kbaytop1@jhmi.edu
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators
  • Massachusetts General Hospital
  • University of Maryland, College Park
  • University of North Carolina, Chapel Hill
  • Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Joanna MP Melia, MD Johns Hopkins University
Principal Investigator: Ashwin Ananthakrishnan, MD Massachusetts General Hospital
PRS Account Johns Hopkins University
Verification Date May 2020