Adalimumab for Pediatric Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+25 other locations

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

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.

Inclusion Criteria

Subject must have successfully enrolled and completed M11-290 study

Exclusion Criteria

Subject considered by the investigator, for any reason, to be an unsuitable candidate

Treatment Details

Interventions

Adalimumab (TNF-alpha inhibitor)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Subjects receiving AdalimumabExperimental Treatment1 Intervention

Subjects receiving Adalimumab up to 288 weeks

Adalimumab is already approved in Canada, Japan for the following indications: