24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/14/2018 |
| Start Date: | April 10, 2014 |
| End Date: | March 28, 2018 |
A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis
The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data,
and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic
Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),
disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis
factor alpha (TNFα) therapy.
and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic
Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),
disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis
factor alpha (TNFα) 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.
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
13
sites
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