NCT00686374

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

A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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

• Crohn's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-05-01
• Primary completion: 2017-04-04
• Completion: 2017-04-04
• First posted: 2008-05-29
• Last updated: 2018-07-02
• Results posted: 2018-04-20

Regulatory

• FDA-regulated drug study