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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2 March 2015 |
Main ID: |
EUCTR2011-000276-34-SK |
Date of registration:
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30/06/2011 |
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 |
Date of first enrolment:
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28/09/2011 |
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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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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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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DRA dept.
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Address:
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Galvaniho 15/A
821 04
Bratislava
Slovakia |
Telephone:
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+421250706111 |
Email:
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DRA.Slovakia@novartis.com |
Affiliation:
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Novartis Slovakia s.r.o. |
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Name:
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DRA dept.
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Address:
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Galvaniho 15/A
821 04
Bratislava
Slovakia |
Telephone:
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+421250706111 |
Email:
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DRA.Slovakia@novartis.com |
Affiliation:
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Novartis Slovakia s.r.o. |
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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: 16.0
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: 24 weeks
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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 in the subgroup of subjects who are TNFa inhibitor naïve.
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Primary end point(s): ACR 20
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Secondary Objective: • Proportion of subjects achieving an ACR20 response in the entire study population at Week 24. • HAQ-DI in the subgroup of subjects who are TNFa inhibitor naïve at Week 24. • Joint/bone structural damage (van der Heijde modified total Sharp score) in the subgroup of subjects who are TNFa inhibitor naïve at Week 24. • Proportion of subjects achieving Major Clinical Response at Week 52 in the subgroup of subjects who are TNFa inhibitor naïve at Week 52.
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Secondary Outcome(s)
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Secondary end point(s): - HAQ-DI, and van der Heijde modified total Sharp Score
- Major clinical response
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Timepoint(s) of evaluation of this end point: Respectively:
- 16 weeks
- 52 weeks
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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 AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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