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)

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Secukinumab (75 mg) — DRUG
  Secukinumab (75 mg)
• Secukinumab (150 mg) — DRUG
  Secukinumab (150 mg)
• Placebo Comparator — DRUG
  Placebo Comparator

Study Details

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.

Key Dates

Start date

Sep 30, 2011

Status verified

Jan 2016

Primary completion

Oct 31, 2014

Completion

Oct 31, 2014

Study Design

Enrollment

606 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1
  Secukinumab (75mg)
• Experimental: Group 2
  Secukinumab (150 mg)
• Placebo Comparator: Group 3

Primary Outcome Measure

Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo [ Time Frame: Week 24 ]

Locations (25)

Find similar trials in Anniston, AL

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