A randomized, double-blind, active control, multicenter study to evaluate the efficacy at week 52 of subcutaneously administered secukinumab monotherapy compared with subcutaneously administered adalimumab monotherapy in patients with active psoriatic arthritis
- Conditions
- psoriatic arthritis1002321310014982
- Registration Number
- NL-OMON45596
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Diagnosis of PsA classified by CASPAR; Rheumatoid factor and anti-CCP antibodies negative; diagnosis of active plaque psoriasis, with at least one psoriatic plaque of *2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis; inadequate control of symptoms with NSAIDs; inadequate control of symptoms with a conventional DMARD.;Other protocol-defined inclusion criteria may apply. See protocol for more details.
Pregnant or nursing women, evidence of ongoing infectious or malignant process; previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis; subjects taking high potency opioid analgesics; ongoing use of prohibited psoriasis treatments / medications; previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents;Other protocol-defined exclusion criteria may apply. See protocol for more details.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To demonstrate that the efficacy of secukinumab monotherapy 300 mg s.c.at Week<br /><br>52 is superior to adalimumab monotherapy (40 mg s.c.) based on the proportion<br /><br>of subjects achieving an American College of Rheumatology 20 (ACR20) response.</p><br>
- Secondary Outcome Measures
Name Time Method