Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

Part of paid clinical trials in Orlando, Florida.

Sponsor
AbbVie
Study ID
NCT02632175
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    every other week or weekly subcutaneous injection

Study Details

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

Key Dates

Start date
Nov 26, 2015
Status verified
Sep 2025
Primary completion
Apr 8, 2025
Completion
Apr 8, 2025

Study Design

Enrollment
59 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Subjects receiving Adalimumab
    Subjects receiving Adalimumab up to 288 weeks

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks). ]

Locations (4)

FacilityCityStateZIPSite coordinators
Arnold Palmer Hospital /ID# 147295OrlandoFlorida32806-
MNGI Digestive Health, P. A. /ID# 147294MinneapolisMinnesota55413-2195-
Mayo Clinic - Rochester /ID# 147304RochesterMinnesota55905-0001-
MultiCare Institute Health System /ID# 169005TacomaWashington98405-

Related coverage on Hipa.ai

Find similar trials in Orlando, FL

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Arnold Palmer Hospital· Orlando, FLMNGI Digestive Health, P. A.· Minneapolis, MNMayo Clinic - Rochester· Rochester, MNMultiCare Institute Health System· Tacoma, WA

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