NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Psoriasis, Arthritic
Date of first enrollment	22/05/2013
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : ixekizumab (LY2439821) INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : ixekizumab Dosing Regimen 1:Administered by 80 milligram (mg) subcutaneous (SC) injection Generic name etc : ixekizumab (LY2439821) INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : ixekizumab Dosing Regimen 2:Administered by 80 milligram (mg) SC injection control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo for ixekizumab and placebo for adalimumab administered by SC injection Generic name etc : Adalimumab INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Administered by 40 mg SC injection

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	* Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria * Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints * Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps) * Men must agree to use a reliable method of birth control or remain abstinent during the study * Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclude criteria	* Current or prior use of biologic agents for treatment of Ps or PsA * Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs) * Current use of more than one conventional DMARD * Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA * Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab * Serious disorder or illness other than psoriatic arthritis * Serious infection within the last 3 months * Breastfeeding or nursing (lactating) women