Adalimumab for Pediatric Ulcerative Colitis
Palo Alto (17 mi)Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AbbVie
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
Eligibility Criteria
This trial is for children with ulcerative colitis who have finished the M11-290 study. It's not open to those whom the investigator thinks shouldn't participate for any reason.Treatment Details
The trial is looking at how safe and effective Adalimumab, a medication used to treat inflammatory conditions, is over a long period in kids with ulcerative colitis.
1Treatment groups
Experimental Treatment
Group I: Subjects receiving AdalimumabExperimental Treatment1 Intervention
Subjects receiving Adalimumab up to 288 weeks
Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
🇺🇸 Approved in United States as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
- Hidradenitis suppurativa
🇨🇦 Approved in Canada as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
🇯🇵 Approved in Japan as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
Find a clinic near you
Research locations nearbySelect from list below to view details:
Arnold Palmer Hosp Children /ID# 147295Orlando, FL
Mayo Clinic /ID# 147304Rochester, MN
MultiCare Institute Health Sys /ID# 169005Tacoma, WA
MNGI Digestive Health, P. A. /ID# 147294Minneapolis, MN
More Trial Locations
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Who is running the clinical trial?
AbbVieLead Sponsor