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

July 7, 2011
June 18, 2014
September 2011
November 2014   (final data collection date for primary outcome measure)
Proportion of patients achieving ACR20 response criteria on secukinumab 75 or 150 mg vs. placebo [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Proportion of patients achieving ACR20 response criteria on secukinumab 75 or 150 mg vs. placebo, in the subgroup of patients who are TNFα inhibitor naïve [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01392326 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) on secukinumab 75 or 150 mg vs. placebo, in the subgroup of subjects who are TNFα inhibitor naïve [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving ACR20 response criteria on secukinumab 75 or 150 mg vs. placebo, in the entire study population [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline for joint/bone structural damage (as measured by the van der Heijde modified total Sharp score) on secukinumab 75 and 150 mg in the subgroup of subjects who are TNFα inhibitor naïve [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving Major Clinical Response (defined as continuous 6-months of ACR70 response during 52 weeks) on secukinumab 75 or 150 mg vs. placebo (as originally randomized), in the subgroup of subjects who are TNFα inhibitor naïve [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriatic Arthritis
  • Drug: Secukinumab (75 mg)
    Secukinumab (75 mg)
  • Drug: Secukinumab (150 mg)
    Secukinumab (150 mg)
  • Drug: Placebo Comparator
    Placebo Comparator
  • Experimental: Group 1
    Secukinumab (75mg)
    Intervention: Drug: Secukinumab (75 mg)
  • Experimental: Group 2
    Secukinumab (150 mg)
    Intervention: Drug: Secukinumab (150 mg)
  • Placebo Comparator: Group 3
    Intervention: Drug: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
606
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Germany,   Israel,   Italy,   Philippines,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   Thailand,   United Kingdom
 
NCT01392326
CAIN457F2306, 2011-000276-34
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP