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Standardized Initial Therapy for Newly Diagnosed Pediatric UC (PROTECT)
NCT01536535Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2012
- Primary completion
- Apr 2018
- Countries
- 2
- Sponsor
- Connecticut Children's Medical Center
- Modality
- Orthosteric Ligands
- Drugs
- Salcrozineprednisone
- Conditions
- ulcerative colitis (UC)
01
Overview
Phase 4, open-label trial of Salcrozine and prednisone in ulcerative colitis (UC) (2 arms), sponsored by Connecticut Children's Medical Center. Primary endpoints: Number of Participants With Corticosteroid Free Remission (SFR) at 52 weeks and Number of Participants Who Needed Additional Therapy or Colectomy at 52 weeks. Started Jul 2012; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Mild UC
Initiated on Mesalamine or Oral CS (PUCAI < 45)
Moderate to Severe UC
Initiated on IV CS or Oral CS (PUCAI >= 45)
03
Who it enrols
Children aged 4-17 with newly diagnosed ulcerative colitis (PUCAI >= 10) extending beyond the rectosigmoid. Excludes patients with Crohn's disease, prior UC therapy, or active enteric infections.
04
Endpoints
Primary
Number of Participants With Corticosteroid Free Remission (SFR)
Number of Participants Who Needed Additional Therapy or Colectomy
Secondary
Number of Participants Receiving a Colectomy
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