Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
Status: | Completed |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2011 |
End Date: | October 2014 |
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis
This study will assess the efficacy and safety of secukinumab in patients with active
psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs,
DMARDs and / or TNFα inhibitor therapy.
psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs,
DMARDs and / or TNFα inhibitor therapy.
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 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 o plaque
psoriasis
Exclusion criteria:
- Chest X-ray with evidence of ongoing infectious or malignant process
- Subjects who have previously been treated with more than 3 different TNFα inhibitors
- Subjects taking high potency opioid analgesics
- Subjects who have ever received biologic immunomodulating agents except for those
targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
24
sites
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