Multi-center Acute Severe Ulcerative Colitis Cohort Study (MASCC)

NCT03669822 | Completed

• 1 other identifier: IRB00174643
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• Inpatient response to medical management

  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)

  In-hospital (approximately 1-2 weeks)

Secondary Outcomes (1)

• Long-term response to medical management

  12 months

Study Arms (1)

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.

Other: Standard of care

Interventions

Standard of care OTHER

Care decisions driven by local physicians; this is an observational cohort.

Inpatient ulcerative colitis patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized ulcerative colitis patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Joanna Melia

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, and colonic biopsies will be collected for a subgroup of participants.

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: September 13, 2018
• Study Start: November 10, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

US (1)