Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab (AIN457) in Patients of Active Psoriatic Arthritis (PsA).

This study is currently recruiting participants.
Verified November 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01752634
First received: October 23, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

This study is to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data will be collected during the post Week 52 period of the study.


Condition Intervention Phase
Psoriatic Arthritis
Biological: AIN457
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • TNFα inhibitor naïve subjects responce by American College of Rheumatology response (ACR20 response) [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of PFS secukinumab at Week 24 is superior to placebo in patients with active PsA in the subgroup of subjects who are TNFα inhibitor naïve based on the proportion of patients achieving an American College of Rheumatology response (ACR20 response)


Secondary Outcome Measures:
  • ACR 20 response in entire study population [ Time Frame: 24 week ] [ Designated as safety issue: No ]
    The efficacy of secukinumab at Week 24 is superior to placebo based on the proportion of subjects achieving an ACR20 response in the entire study population.

  • ACR 50 response in TNFα inhibitor naïve subjects. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The efficacy of secukinumab at Week 24 is superior to placebo based on the proportion of subjects achieving an ACR50 response in the subgroup of subjects who are TNFα inhibitor naïve.

  • Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24 in the subgroup of subjects who are TNFα inhibitor naïve. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The improvement (change) from baseline on secukinumab is superior to placebo for the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24 in the subgroup of subjects who are TNFα inhibitor naïve.


Estimated Enrollment: 400
Study Start Date: April 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: secukinumab (AIN457) 150 mg s.c. + MTX
Group 2 - 150 mg secukinumab: secukinumab 150 mg (1.0 mL) plus placebo (0.5 and 1.0 mL) at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
Biological: AIN457
secukinumab (AIN457)
Experimental: secukinumab (AIN457) 75 mg s.c. +MTX
Group 1- 75 mg secukinumab: secukinumab 75 mg (0.5 mL) plus placebo (2 x 1.0 mL) at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
Biological: AIN457
secukinumab (AIN457)
Placebo Comparator: Placebo s.c. + MTX
Group 4 - placebo: Placebo 2 x 1.0 mL and 1 x 0.5 mL at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4
Drug: Placebo
Placebo 1.0 mL PFS for s.c. administration.
Other Name: sub cutaneous intervention of Placebo 1.0 mL with PFS
Experimental: secukinumab 300 mg (AIN457 ) s.c. + MTX
Group 3 - 300 mg secukinumab: secukinumab 300 mg (2 x 1.0 mL) plus placebo (0.5 mL) at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4
Biological: AIN457
secukinumab (AIN457)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Patients eligible for inclusion in this study have to fulfill all of the following 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 Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
  • Rheumatoid factor and anti-CCP antibodies negative at screening
  • Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or 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 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.

Exclusion Criteria:Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

  • Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
  • Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
  • 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. The following wash out periods need to be observed:
  • Oral or topical retinoids 4 weeks
  • Photochemotherapy (e.g. PUVA) 4 weeks
  • Phototherapy (UVA or UVB) 2 weeks
  • Topical skin treatments (except in face, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks
  • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα, investigational or approved
  • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752634

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111 ext +41613241111

  Show 119 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01752634     History of Changes
Other Study ID Numbers: CAIN457F2312, 2012-004439-22
Study First Received: October 23, 2012
Last Updated: November 18, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Thailand: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Therapeutic Goods Administration (TGA)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency (Anvisa)
Canada: Health Canada (Biologics and Genetic Therapies Directorate)
Czech Republic: State institute for drug control (SUKL)
Germany: Federal Institute for Vaccines and Biomedicines (PEI)
Philippines: Department of Health
Poland: Minister of Health
Russia: Ministry of Public Health and Social Development of the Russian Federation

Keywords provided by Novartis:
Psoriatic arthritis, PsA, ACR, CASPAR, PASDAS

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014