NCT01251614

A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate

A Multicenter, Randomized, Double-dummy, Double-blind Study Evaluating Two Doses of Adalimumab Versus Methotrexate (MTX) in Pediatric Subjects With Chronic Plaque Psoriasis (Ps)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study will compare how well adalimumab works versus methotrexate (MTX) in children with moderate to severe psoriasis in the short term. It will also study how safe and how well adalimumab works in the long term and how long disease response can be maintained after stopping therapy.

Detailed description

The study had a 30-day screening period and a multi-period study design, as described below: Period A - Primary Treatment Phase: Participants were randomized to receive adalimumab 0.8 mg/kg, adalimumab 0.4 mg/kg, or MTX in 1:1:1 ratio for 16 weeks. Period B - Treatment Withdrawal Phase: Responders were withdrawn from active treatment and monitored for loss of disease control for up to 36 weeks. Period C - Re-Treatment Phase: Participants who had experienced loss of disease control in Period B were re-treated with adalimumab for 16 weeks. Period D - Long-Term Follow-Up Phase: Participants received adalimumab or were observed off-treatment (if disease remained under control) for 52 weeks.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab	Adalimumab by subcutaneous injection every other week (eow)
DRUG	Methotrexate	Methotrexate 0.1 mg/kg at Week 0 and up to 0.4 mg/kg per week (maximum dose of 25 mg/week) orally.
BIOLOGICAL	Placebo to Adalimumab	A single subcutaneous loading dose at Week 0 followed by eow dosing beginning at Week 1.
DRUG	Placebo to Methotrexate	Orally once a week

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-12-01
• Completion: 2015-02-01
• First posted: 2010-12-02
• Last updated: 2017-09-25
• Results posted: 2017-04-04