Comparison of Ixekizumab with Adalimumab in Patients with Psoriatic Arthritis

INTERVENTION:

Intervention1: Ixekizumab: Ixekizumab ‐ 80 mg subcutaneous (SC)injection: A starting dose of ixekizumab 160 mg (two 80‐mg SC injections) will be administered at randomization (Visit 2 [Week 0]) for all patients ï?· Patients with moderate‐to‐severe plaque psoriasis (Ps), defined as PASI â?¥12, static Physicianâ??s Global Assessment (sPGA) â?¥3, and BSA â?¥10%, will receive ixekizumab 80 mg given as 1SC injection every 2 weeks (Q2W) from Week 2 to Week 12 and every 4 weeks (Q4W) thereafter ï?· Patients not meeting criteria for moderate‐to‐severe plaque Ps at randomization will receive ixekizumab 80 mg given as 1 SC injection Q4W starting at Week 4 Control Intervention1: Adalimumab: Adalimumab 40 mg SC injection: Patients with moderate‐to‐severe plaque Ps, defined as PASI â?¥12, sPGA â?¥3, and BSA â?¥10%, will receive a starting dose of adalimumab 80 mg (two 40‐mg SC injections) administered at randomization (Visit 2 [Week 0]) followed by 40 mg given as 1 SC injection Q2W starting at Week 1 ï?· Patients not meeting criteria for moderate‐to‐severe plaque Ps will receive a starting dose of adalimumab 40 mg given as 1 SC injection at randomization (Visit 2 [Week 0]) followed by 40 mg given as 1 SC injection Q2W starting at Week 2

CONDITION:

Patients with Psoriatic Arthritis

PRIMARY OUTCOME:

To assess whether ixekizumab ; is superior to adalimumab at ; Week 24 in the treatment of ; patients with active PsA as ; measured by American College ; of Rheumatology 50 (ACR50) ; and Psoriasis Area and Severity Index 100 (PASI 100)‐‐‐‐‐‐Timepoint: Proportion of patients simultaneously achieving ACR50 and PASI 100 ; at Week 24 ;

SECONDARY OUTCOME:

To assess whether ixekizumab ; is noninferior to adalimumab at Week 24 in the treatment of ; patients with active PsA as ; measured by ACR50‐‐‐‐‐‐Timepoint: Proportion of patients achieving ACR50 in each treatment group at Week 24 To assess whether ixekizumab ; is superior to adalimumab at ; Week 24 in the treatment of ; patients with active PsA as ; measured by PASI 100‐‐‐‐‐‐Timepoint: Proportion of patients achieving PASI 100 in each treatment group at Week 24

INCLUSION CRITERIA:

1] Are male or female patients 18 years or older [1a] Male patients agree to use a reliable method of birth control during the study. [1b] Female patients: Are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after the last dose of investigational product, whichever is longer. Methods of contraception considered acceptable when used properly include oral contraceptives, contraceptive patch, injectable or implantable contraceptives, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive foam. OR Are women of non childbearing potential, defined as: Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation); OR Women who are â?¥60 years of