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) (FUTURE 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01392326
First received: July 7, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Secukinumab (75 mg)
Drug: Secukinumab (150 mg)
Drug: Placebo Comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients achieving ACR20 response criteria on secukinumab 75 or 150 mg vs. placebo [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving a PASI75 response in the subgroup of subjects who have ≥3% skin involvement with psoriasis [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a PASI90 response in the subgroup of subjects who have ≥3% skin involvement with psoriasis [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in DAS28-CRP for secukinumab 75 or 150 mg [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in SF36-PCS for secukinumab 75 or 150 mg [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in HAQ-DI for secukinumab 75 or 150 mg [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving ACR50 response criteria on secukinumab 75 or 150 mg vs. placebo [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline for joint/bone structural damage (van der Heijde modified total Sharp score) for secukinumab 75 and 150 mg (pooled doses) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients with dactylitis in the subset of subjects who have dactylitis at baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients with enthesitis in the subset of subjects who have enthesitis at baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline for joint/bone structural damage (van der Heijde modified total Sharp score) for secukinumab 75 or 150 mg [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment: 606
Study Start Date: September 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Secukinumab (75mg)
Drug: Secukinumab (75 mg)
Secukinumab (75 mg)
Experimental: Group 2
Secukinumab (150 mg)
Drug: Secukinumab (150 mg)
Secukinumab (150 mg)
Placebo Comparator: Group 3 Drug: Placebo Comparator
Placebo Comparator

  Eligibility

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

Inclusion criteria:

  • Male or non-pregnant, non-lactating female patients at least 18 years of age
  • 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
  • Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis

Exclusion criteria:

  • Chest X-ray with evidence of ongoing infectious or malignant process
  • Subjects who have previously been treated with more than 3 different TNFα inhibitors
  • Subjects taking high potency opioid analgesics
  • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392326

  Show 109 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: NCT01392326     History of Changes
Other Study ID Numbers: CAIN457F2306, 2011-000276-34
Study First Received: July 7, 2011
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: Ethics Committee
Peru: Ministry of Health
Philippines: Department of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Thailand: Ethical Committee
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Psoriatic arthritis
PsA
ACR
CASPAR

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014