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

Conditions

• Chronic Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• adalimumab — BIOLOGICAL
  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
• Calcipotriol/Betamethasone Ointment — DRUG
  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
• placebo (vehicle ointment) — DRUG
  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

Study Details

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.

Key Dates

Start date

Nov 30, 2007

Status verified

Apr 2011

Primary completion

Oct 31, 2008

Study Design

Enrollment

730 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: adalimumab + placebo
  adalimumab + placebo (vehicle ointment)
• Active Comparator: adalimumab + calcipotriol/betamethasone
  adalimumab + calcipotriol/betamethasone ointment

Primary Outcome Measure

Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) [ Time Frame: Week 0 and Week 16 ]