59 Participants Needed

Adalimumab for Pediatric Ulcerative Colitis

Recruiting at 25 trial locations
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: AbbVie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

AI

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Adalimumab for up to 288 weeks to assess long-term safety and efficacy

288 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Open-label extension

Participants may continue to receive Adalimumab beyond the initial treatment period

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Adalimumab
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Subjects receiving AdalimumabExperimental Treatment1 Intervention

Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Humira for:
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Approved in United States as Humira for:
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Approved in Canada as Humira for:
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Approved in Japan as Humira for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

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