NCT00574249

Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment

A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 730 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.

Detailed description

Additional information regarding sponsors: Abbott GmbH \& Co. KG is sponsor for EU member states. Abbott US is sponsor for non-EU member states.

Conditions

• Chronic Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	adalimumab	subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15
DRUG	Calcipotriol/Betamethasone Ointment	Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
DRUG	placebo (vehicle ointment)	Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-10-01
• First posted: 2007-12-17
• Last updated: 2011-04-13
• Results posted: 2010-01-18

Locations

131 sites across 15 countries: Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom