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) (FUTURE 1)

Novartis

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Secukinumab (150 mg); Drug: Secukinumab (75 mg); Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392326

CAIN457F2306

2011-000276-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 606 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

606 participants in 3 patient groups, including a placebo group

Group 1

Experimental group

Description:

Secukinumab (75mg)

Treatment:

Drug: Secukinumab (75 mg)

Group 2

Experimental group

Description:

Secukinumab (150 mg)

Treatment:

Drug: Secukinumab (150 mg)

Group 3

Placebo Comparator group

Treatment:

Drug: Placebo Comparator