Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/16/2018 |
Start Date: | June 27, 2016 |
End Date: | October 1, 2018 |
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis After 16 Weeks of Treatment Compared to Placebo and to Assess the Safety, Tolerability and Efficacy up to 52 Weeks
To demonstrate that the efficacy of secukinumab 300 mg at Week 16 is superior to placebo in
adult patients with active PsA based on the proportion of patients achieving an American
College of Rheumatology 20 (ACR20) response.
adult patients with active PsA based on the proportion of patients achieving an American
College of Rheumatology 20 (ACR20) response.
Inclusion Criteria:
- Male or non-pregnant, non-lactating female patients at least 18 years of age
- Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months
with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and
≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
- Rheumatoid factor and/or anti-CCP antibodies negative at screening
- A target skin psoriatic lesion and a PASI score of 1 or greater
Exclusion Criteria:
- Chest X-ray with evidence of ongoing infectious or malignant process
- Patients who ever received biologic immunomodulating agents including those targeting
TNFα, IL-6 and IL-12/23 investigational or approved
We found this trial at
61
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