Status:
COMPLETED
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Arthritis, Psoriatic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or witho...
Eligibility Criteria
Inclusion
- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria.
- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
- Inadequate control of symptoms with NSAID.
- Other protocol-defined inclusion criteria do apply.
Exclusion
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- Subjects taking high potency opioid analgesics.
- Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
- Ongoing use of prohibited psoriasis treatments / medications.
- Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα.
- Previous treatment with any cell-depleting therapies.
Key Trial Info
Start Date :
May 29 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2017
Estimated Enrollment :
341 Patients enrolled
Trial Details
Trial ID
NCT02294227
Start Date
May 29 2015
End Date
December 19 2017
Last Update
July 2 2019
Active Locations (64)
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1
Novartis Investigative Site
Mesa, Arizona, United States, 85202
2
Novartis Investigative Site
Upland, California, United States, 91786
3
Novartis Investigative Site
Denver, Colorado, United States, 80230
4
Novartis Investigative Site
Palm Harbor, Florida, United States, 34684