Plaque Psoriasis Clinical Trial
Official title:
A Multicenter, Randomized, Double-dummy, Double-blind Study Evaluating Two Doses of Adalimumab Versus Methotrexate (MTX) in Pediatric Subjects With Chronic Plaque Psoriasis (Ps)
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.
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Period B - Treatment Withdrawal Phase: Responders were withdrawn from active treatment and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.
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