Study to demonstrate the efficacy (including inhibition of structural damage), safety and tolerability up to 2 years of secukinumab in Active Psoriatic Arthritis

Phase 1

• Conditions: Psoriatic Arthritis; MedDRA version: 19.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-000050-38-FI
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 990

Inclusion Criteria

-Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL =3 tender joints out of 78 and =3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).
-Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
-Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
-Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs.
-Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
-Subjects taking corticosteroids must be on a stable dose of =10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24.
-Subjects taking MTX (= 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.
-Subjects on MTX must be on folic acid supplementation at randomization.
-Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
-Subjects who have been on a TNFa inhibitor must have experienced an inadequate response to previous or current treatment with a TNFa inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFa inhibitor.
-Subjects who have previously been treated with TNFa inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization.
-Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 920
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

-Chest X-ray or chest 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 IL-17 or IL-17 receptor.
-Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
-Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
-Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa (investigational or approved).
-Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents
-Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified