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 not yet open for participant recruitment.
Verified December 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01752634
First received: October 23, 2012
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
This study is to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab 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 Biological: 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: | January 2013 |
| Estimated Study Completion Date: | February 2019 |
| Estimated Primary Completion Date: | February 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 150 mg AIN457 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
|
|
Experimental: 75 mg AIN457 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
|
|
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
|
Biological: Placebo
Placebo 1.0 mL PFS for s.c. administration.
|
|
Experimental: 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
|
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 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: | December 18, 2012 |
| 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) Israel: Ministry of Health 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 May 16, 2013