Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AIN457 (secukinumab) — DRUG
  Is a recombinant monoclonal antibody which neutralizes the activity of IL-17A, and has been shown to be effective in treating patients with moderate-to-severe plaque psoriasis. Secukinumab 150 mg provided in 1 mL pre filled syringes (PFS) for s.c. injection. The 300 mg dose was administered as 2 × PFS injections.
• Placebo — DRUG
  Secukinumab placebo was provided in a 1 mL PFS for s.c. injection.

Study Details

This study was designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis were assessed using the OMERACT enthesitis score.

Key Dates

Start date

Aug 22, 2016

Status verified

Nov 2021

Primary completion

Nov 10, 2020

Completion

Nov 10, 2020

Study Design

Enrollment

166 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Group 1
  In Treatment Period-1: Patients in this group were administered secukinumab with 12 weeks of treatment from baseline. In Treatment Period-2: Patients continued to receive the same active dose of secukinumab every 4 weeks until Week 24 In Treatment Period 3 (extension period): the extension period allowed responder patients the possibility to continue open-label secukinumab treatment up to Week 52
• Placebo Comparator: Group 2
  In Treatment Period-1: Patients received placebo at baseline and same time points as secukinumab until Week 8. In Treatment Period-2: Patients commenced open-label secukinumab every 4 weeks from Week 12, as follows, based on their clinical characteristics at Week 12 In Treatment Period-3: Open-label secukinumab continued to be assigned to patients

Primary Outcome Measure

Difference Between Secukinumab and Placebo in Terms of Joint Synovitis as Measured by the Power Doppler Ultrasonography (PDUS) Global OMERACT-EULAR Synovitis Score (GLOESS) [ Time Frame: 12 weeks ]

Locations (4)

Find similar trials in Beverly Hills, CA

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