16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/6/2018 |
| Start Date: | May 29, 2015 |
| End Date: | December 19, 2017 |
A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)
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 without a loading regimen and maintenance dosing using pre-filled
syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with
active PsA despite current or previous NSAID or DMARD therapy
versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.)
self-administration with or without a loading regimen and maintenance dosing using pre-filled
syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with
active PsA despite current or previous NSAID or DMARD therapy
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
21
sites
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