Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement (MAXIMISE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Axial Psoratic Arthritis

Treatments: Biological: Secukinumab; Drug: Secukinumab and Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02721966

2016-000814-31 (EudraCT Number)

CAIN457F3302

Details and patient eligibility

About

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

Full description

In the anlalysis (CSR), there are 498 patients, as 5 patients were mis-randomized, i.e. had randomization number but did never take study medication. So there were 498 participants, and not 503

Enrollment: 503 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed
• Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
• Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
• Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
• Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period

Exclusion criteria

• History of exposure to other IL-17 or IL-23 inhibitor biologic drug
• History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
• Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
• Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
• Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician

Other protocol-defined inclusion and exclusion criteria may have applied.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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503 participants in 3 patient groups, including a placebo group

AIN457 150mg

Experimental group

Description:

Secukinumab dose amount 1 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 1 sc injection every 4 weeks for remaining 44 weeks

Treatment:

Biological: Secukinumab

AIN457 300mg

Experimental group

Description:

Secukinumab dose amount 2 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 2 sc injection every 4 weeks for remaining 44 weeks

Treatment:

Biological: Secukinumab

AIN457 Placebo

Placebo Comparator group

Description:

Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab 150 mg or 300 mg sc injection every 4 week for remaining 40 weeks.

Treatment:

Drug: Secukinumab and Placebo

Biological: Secukinumab