Overview

This trial is active, not recruiting.

Condition psoriatic arthritis
Treatments secukinumab, placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date April 2014
End date January 2018
Trial size 414 participants
Trial identifier NCT01989468, 2013-004002-25, CAIN457F2318

Summary

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Secukinumab 150 mg at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
secukinumab
Eligible subjects are randomised to each of three treatment arms in a 1:1:1 ratio
(Experimental)
Secukinumab 300 mg at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
secukinumab
Eligible subjects are randomised to each of three treatment arms in a 1:1:1 ratio
(Placebo Comparator)
Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
placebo
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Primary Outcomes

Measure
American College of Rheumatology 20 (ACR20) response in subjects treated with secukinumab versus placebo
time frame: 24 weeks

Secondary Outcomes

Measure
American College of Rheumatology 50 (ACR50) response in subjects treated with secukinumab versus placebo
time frame: 24 weeks
Disease Activity Score for 28 joints (DAS28-CRP) (utilizing hsCRP) relative to baseline, assessed in subjects treated with secukinumab versus placebo
time frame: 24 weeks
Psoriatic Area and Severity Index 75 (PASI75) response in subjects treated with secukinumab versus placebo
time frame: 24 weeks
Physical function component of the short-form health survey (SF-36-PCS), relative to baseline, in subjects treated with secukinumab versus placebo
time frame: 24 weeks
Psoriatic Area and Severity Index 90 (PASI90) response in subjects treated with secukinumab versus placebo
time frame: 24 weeks
Health Assessment Questionnaire - Disability Index (HAQ-DI score), relative to baseline, in subjects treated with secukinumab versus placebo
time frame: 24 weeks
Presence of Dactylitis), in subjects treated with secukinumab versus placebo
time frame: 24 weeks
Presence of Enthesitis, in subjects treated with secukinumab versus placebo
time frame: 24 weeks
Overall safety and tolerability
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria. - Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative. - Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis. - Inadequate control of symptoms with NSAID. Exclusion Criteria: - Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics. - Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications. - Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα. - Previous treatment with any cell-depleting therapies.

Additional Information

Official title A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Novartis.