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Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806

NCT00686374 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-02

Study results available
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Summary

This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody adalimumab as an effective therapy for maintaining clinical response in pediatric participants with Crohn's disease (CD) and to gather long-term safety and tolerability data in this population. Participants were allowed to enroll in the study if they participated in and successfully completed Study M06-806 (NCT00409682) through Week 52.

Conditions

Interventions

BIOLOGICAL

Adalimumab

Participants who enrolled into the study from blinded therapy in Study M06-806 received open-label (OL) therapy at a dose dependent on their body weight. Participants weighing ≥ 40 kg received 40 mg of adalimumab every other week (eow), and those who weighed \< 40 kg received 20 mg of adalimumab eow. Starting at Week 8, participants who had a disease flare may have been switched to every week (ew) treatment at the same dose of adalimumab received while on eow treatment. Participants who enrolled from OL therapy in Study M06-806 continued to receive the same dose they were receiving (i.e., 40 mg ew or 20 mg ew) at the Week 52 visit of Study M06-806. Adalimumab dose could have been decreased to the next lower treatment level for those with body weight changes. Participants who responded to treatment may have also had their dosage frequency decreased from ew to eow dosing, as well as a decrease in dosage.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Andreas Lazar · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-01
Primary Completion
2017-04-04
Completion
2017-04-04
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00686374 on ClinicalTrials.gov