NCT01181570

Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Innovaderm Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effect and safety of adalimumab in approximately 20 subjects with mild to moderate psoriasis and sleep apnea and will be conducted in one treatment center located in Montreal. Patients with psoriasis often have additional disorders such as obesity. Obese patients are more at risk of developing obstructive sleep apnea. This is believed to be caused by both the collapse of upper airways and inflammation (swelling). Adalimumab, a drug currently approved by Health Canada for the treatment of psoriasis, blocks tumor necrosis factor-alpha (TNF-alpha). This chemical is present at higher levels in patients with sleep apnea. It is believed that adalimumab could improve obstructive sleep apnea by lowering the levels of TNF-alpha.

Conditions

• Psoriasis
• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DRUG	Adalimumab	Patients receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter.
DRUG	Placebo	Patients will receive 2 injections of placebo at week 0, one injection at week 1 and one injection every other week (EOW) thereafter.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2010-08-13
• Last updated: 2011-10-28

Locations

1 site across 1 country: Canada