Zymfentra (Infliximab-dyyb) REal World Cohort STudy

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07237516
Status
Recruiting
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Conditions

  • Crohn's Disease (CD)
  • Indeterminate Colitis
  • Inflammatory Bowel Disease (IBD)
  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.

Key Dates

Start date
Nov 20, 2025
Status verified
Nov 2025
Primary completion
Nov 3, 2028
Completion
Nov 3, 2028

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Clinical remission as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes. [ Time Frame: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52. ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06510
Elizabeth Ruggiero
[email protected]
203-785-4138
Jill Gaidos, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Jessica Valestin
[email protected]
319-353-4574
Steven Polyak, MD (PRINCIPAL_INVESTIGATOR)
Mercy Medical CenterBaltimoreMaryland21202
Liyah Courageux
[email protected]
410-332-9525
Ray Cross, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Mia Silvestri
[email protected]
617-525-7011
Jessica Allegretti, MD (PRINCIPAL_INVESTIGATOR)
New York UniversityNew YorkNew York10016
Nathasha Melukkaran
[email protected]
646-754-3417
David Hudesman, MD (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599-7080
Jenn Barr
[email protected]
919-966-0764
Hans Herfarth, MD, PhD (PRINCIPAL_INVESTIGATOR)
Atrium Health Center for Gastroenterology and SurgeryCharlotteNorth Carolina28204
Jessica Kearney-Bryan
[email protected]
704-355-0244
Maithili Chitnavis, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest School of MedicineWinston-SalemNorth Carolina27157
Cheyenne Barnett
[email protected]
336-716-6965
Richard Bloomfeld, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45267
Missy Randolph
[email protected]
513-558-5529
Loren Brook, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By research site
Yale University School of Medicine· New Haven, CTUniversity of Iowa· Iowa City, IAMercy Medical Center· Baltimore, MDBrigham and Women's Hospital· Boston, MANew York University· New York, NYUniversity of North Carolina· Chapel Hill, NC

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