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)

January 5, 2016 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

606

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1417EYG
        • Novartis Investigative Site
      • Cordoba, Argentina, X5016KEH
        • Novartis Investigative Site
      • Cordoba, Argentina, X5022CPU
        • Novartis Investigative Site
      • Cordoba, Argentina, X5000EOC
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1181ACH
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1419AHN
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CFJ
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S200BHD
        • Novartis Investigative Site
  • Australia
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Novartis Investigative Site
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Novartis Investigative Site
  • Belgium
      • Genk, Belgium, 3600
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, Brazil, 04266-010
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 04023-900
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Sevlievo, Bulgaria, 5400
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1709
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1612
        • Novartis Investigative Site
  • Canada
    • Newfoundland and Labrador
      • St. John, Newfoundland and Labrador, Canada, A1B 5E8
        • Novartis Investigative Site
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Novartis Investigative Site
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 3R7
        • Novartis Investigative Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Novartis Investigative Site
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Novartis Investigative Site
  • Czech Republic
      • Bruntal, Czech Republic, 792 01
        • Novartis Investigative Site
      • Uherske Hradiste, Czech Republic, 686 01
        • Novartis Investigative Site
      • Zlin, Czech Republic, 760 01
        • Novartis Investigative Site
  • Germany
      • Aachen, Germany, 52064
        • Novartis Investigative Site
      • Berlin, Germany, 12203
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Erlangen, Germany, 91056
        • Novartis Investigative Site
      • Gommern, Germany, 39245
        • Novartis Investigative Site
      • Hamburg, Germany, 22415
        • Novartis Investigative Site
      • Hamburg, Germany, 22143
        • Novartis Investigative Site
      • Herne, Germany, 44649
        • Novartis Investigative Site
      • Hildesheim, Germany, 31134
        • Novartis Investigative Site
      • Koeln, Germany, 50924
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Nürnberg, Germany, 90429
        • Novartis Investigative Site
      • Ratingen, Germany, 40882
        • Novartis Investigative Site
      • Zerbst, Germany, 39261
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 78278
        • Novartis Investigative Site
      • Haifa, Israel, 3339419
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5266202
        • Novartis Investigative Site
      • Tel-Aviv, Israel, 6423906
        • Novartis Investigative Site
  • Italy
    • (vr)
      • Valeggio Sul Mincio, (vr), Italy, 37067
        • Novartis Investigative Site
    • CT
      • Catania, CT, Italy, 95100
        • Novartis Investigative Site
    • PO
      • Prato, PO, Italy, 59100
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italy, 53100
        • Novartis Investigative Site
  • Philippines
      • Las Pinas, Philippines, 1740
        • Novartis Investigative Site
      • Manila, Philippines, 1000
        • Novartis Investigative Site
      • Manila, Philippines, 1003
        • Novartis Investigative Site
      • Manila, Philippines, 1008
        • Novartis Investigative Site
      • Quezon City, Philippines, 1102
        • Novartis Investigative Site
      • Quezon City, Philippines, 1121
        • Novartis Investigative Site
    • Batangas
      • Lipa City, Batangas, Philippines, 4217
        • Novartis Investigative Site
    • Cavite
      • Dasmarinas, Cavite, Philippines, 4114
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, Philippines, 1003
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-351
        • Novartis Investigative Site
      • Warszawa, Poland, 02-341
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania
        • Novartis Investigative Site
      • Cluj Napoca, Romania, 400006
        • Novartis Investigative Site
      • Iasi, Romania, 700195
        • Novartis Investigative Site
    • District 1
      • Bucharest, District 1, Romania
        • Novartis Investigative Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620028
        • Novartis Investigative Site
      • Ekaterinburg, Russian Federation, 620102
        • Novartis Investigative Site
      • Kemerovo, Russian Federation, 650029
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115522
        • Novartis Investigative Site
      • St-Petersburg, Russian Federation, 190068
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150003
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 529889
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • Slovakia
      • Lucenec, Slovakia, 98401
        • Novartis Investigative Site
    • Slovak Republic
      • Piestany, Slovak Republic, Slovakia, 921 12
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
      • Khon Kaen, Thailand, 40002
        • Novartis Investigative Site
  • United Kingdom
      • Glasgow, United Kingdom, G12 8TA
        • Novartis Investigative Site
      • London, United Kingdom, SE1 9RT
        • Novartis Investigative Site
    • England
      • London, England, United Kingdom, E11 1NR
        • Novartis Investigative Site
    • Staffordshire
      • Cannock, Staffordshire, United Kingdom, WS11 2XY
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD5 0NA
        • Novartis Investigative Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207-5710
        • Novartis Investigative Site
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Novartis Investigative Site
      • Paradise Valley, Arizona, United States, 85253
        • Novartis Investigative Site
    • California
      • Upland, California, United States, 91786
        • Novartis Investigative Site
    • Florida
      • Tamarac, Florida, United States, 33321
        • Novartis Investigative Site
    • Georgia
      • Newnan, Georgia, United States, 30263
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Novartis Investigative Site
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Novartis Investigative Site
    • Missouri
      • Richmond Heights, Missouri, United States, 63117
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Novartis Investigative Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novartis Investigative Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Novartis Investigative Site
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Novartis Investigative Site
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Novartis Investigative Site
      • North Charleston, South Carolina, United States, 29406
        • Novartis Investigative Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Novartis Investigative Site
    • Texas
      • Benbrook, Texas, United States, 76126
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75216
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75246
        • Novartis Investigative Site
      • Houston, Texas, United States, 77034
        • Novartis Investigative Site
      • Houston, Texas, United States, 77074
        • Novartis Investigative Site
      • Mesquite, Texas, United States, 75150
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, United States, 98122
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
Time Frame: Week 24
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
Time Frame: Week 24
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis
Week 24
Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
Time Frame: Week 24
A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis
Week 24
Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg
Time Frame: Week 24
DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: <math>DAS-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96</math> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 ("0":no activity, "100": highest activity possible)
Week 24
Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg
Time Frame: Week 24
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Week 24
Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg
Time Frame: Week 24
HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week "Are you able to …" perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled).
Week 24
Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
Time Frame: Week 24
ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.
Week 24
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
Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.
Week 24
Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline
Time Frame: Week 24
Week 24
Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457F2306
  • 2011-000276-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psoriatic Arthritis

Clinical Trials on Secukinumab (75 mg)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe