Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2011-000276-34-GB |
Date of registration:
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18/07/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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2 year study of secukinumab (AIN457) treatment in patients with active Psoriatic Arthritis
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Scientific title:
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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 - FUTURE-1 |
Date of first enrolment:
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23/08/2011 |
Target sample size:
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600 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000276-34 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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Bulgaria
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Canada
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Czech Republic
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Germany
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Israel
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Italy
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Peru
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Philippines
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Poland
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Romania
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Russian Federation
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Singapore
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Slovakia
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Thailand
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Medical information services
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Address:
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Frimley Business Park, Frimley
GU16 7SR
Camberley, Surrey,
United Kingdom |
Telephone:
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+4401276698370 |
Email:
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medinfo.uk@novartis.com |
Affiliation:
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Novartis Pharmaceuticals UK Ltd |
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Name:
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Medical information services
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Address:
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Frimley Business Park, Frimley
GU16 7SR
Camberley, Surrey,
United Kingdom |
Telephone:
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+4401276698370 |
Email:
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medinfo.uk@novartis.com |
Affiliation:
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Novartis Pharmaceuticals UK Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Male or non-pregnant, non-lactating female patients at least 18 years of age
• Diagnosis of PsA classified by CASPAR criteri 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 joints out of 76 (dactylitis of a digit counts as one joint each)
• Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2 cm diameter (but not in intertriginous areas such as armpits, or chest between breasts, or groin) or nail changes consistent with psoriasis or a documented history of plaque psoriasis
• Patients should have been on NSAIDs with an inadequate response
• Patients who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose
• Patients who have been on an anti-TNFa agent (not more than three) must have experienced an inadequate response
Other protocol-related inclusion criteria may apply.
Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 568 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria: • Chest X-ray with evidence of ongoing infectious or malignant process
• Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
• Patients previously treated with any biological immunomodulating agents except for those targeting TNFa
• Previous treatment with any cell-depleting therapies
Other protocol-related exclusion criteria may apply.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Psoriatic arthritis
MedDRA version: 16.1
Level: LLT
Classification code 10037160
Term: Psoriatic arthritis
System Organ Class: 100000004859
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Intervention(s)
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Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Secukinumab Current Sponsor code: AIN457 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary Objective: • Proportion of subjects achieving a PASI75 response in the subgroup of subjects who have =3% skin involvement with psoriasis • Proportion of subjects achieving a PASI90 response in the subgroup of subjects who have =3% skin involvement with psoriasis • change from baseline in DAS28-CRP for secukinumab 75 or 150mg • change from baseline in SF36-PCS for secukinumab 75 or 150mg • change from baseline in HAQ-DI for secukinumab 75 or 150mg • Proportion of subjects achieving an ACR50 response on secukinumab 75 or 150mg vs. placebo • change from baseline for joint/bone structural damage for secukinumab 75 and 150mg • Proportion of subjects with dactylitis in the subset of subjects who have dactylitis at baseline • Proportion of subjects with enthesitis in the subset of subjects who have enthesitis at baseline • Change from baseline for joint/bone structural damage for secukinumab 75 or 150mg • Overall safety and tolerability of each secukinumab regiment compared to placebo
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Main Objective: To demonstrate the efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo in patients with active PsA based on the proportion of patients achieving an ACR20 response.
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Primary end point(s): ACR 20
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Secondary Outcome(s)
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Secondary end point(s): 1) PASI75 (in the subgroup of subjects who have =3% skin involvement with psoriasis)
2) PASI90 (in the subgroup of subjects who have =3% skin involvement with psoriasis)
3) DAS28-CRP (for secukinumab 75 or 150mg)
4) SF36-PCS (for secukinumab 75 or 150mg)
5) HAQ-DI (for secukinumab 75 or 150mg)
6) ACR50 response on secukinumab 75 or 150mg vs.placebo
7) Change from baseline for joint/bone structural damage (van der Heijdemodified total Sharp score) fro secukinumab 75 and 150mg (pooled doses)
8) Proportion of patients with dactylitis in the subset of subjects who have dactylitis at baseline
9) Proportion of patients with enthesitis in the subset of subjects who have denthesitis at baseline
10) Change from baseline for join/bone structural damage (van der Heijde modified total Sharp score) for secukinumab 75 or 150mg
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary ID(s)
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2011-000276-34-CZ
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CAIN457F2306
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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