Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER II)

• Proportion of subjects achieving clinical response at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]
  Subjects achieving improvement in hidradenitis suppurativa severity.
  
  

• Proportion of subjects achieving counts of 0, 1, or 2 at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]
  Subjects counts lowered to 0, 1, or 2 at Week 12, among subjects with Hurley Stage II at Baseline
  
  
• Reduction in patient skin pain assessment at Week 12 [ Time Frame: Baseline (Week 0) up to Week 12 ] [ Designated as safety issue: No ]
  Proportion of subjects who achieve a reduction, and at least 1 unit reduction from baseline in their skin pain at measured by the Patient's Global Assessment of Skin Pain (NRS30) at Week 12
  
  
• Change in Sartorius scale [ Time Frame: Baseline (Week 0) and Week 12 ] [ Designated as safety issue: No ]
  Change in Sartorius scale from Baseline to Week 12
  
  

The clinical trial identifier is PIONEER II. The purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe hidradenitis suppurativa (HS). HS is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. Sometimes these bumps can heal themselves quickly and sometimes they will become much worse and create sores that heal with multiple combined scars, or areas that do not heal. In this study, approximately 300 adults will be enrolled at treatment centers worldwide. Subject participation in this study will be up to 50 weeks. There will be a screening period, which will last from 7 to 30 days, and a study treatment period of up to 36 weeks. Study visits occur at Screening, Baseline, and Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves the study before Week 36). The study is divided into two treatment periods. The first period (Period A) will last 12 weeks and the second period (Period B) will last 24 weeks.