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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22 December 2015 |
Main ID: |
EUCTR2013-003554-25-ES |
Date of registration:
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07/02/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Brodalumab in Subjects with Psoriatic Arthritis
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects with Psoriatic Arthritis: AMVISION-1 - AMVISION-1 |
Date of first enrolment:
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20/02/2014 |
Target sample size:
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630 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003554-25 |
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: yes
Other specify the comparator: randomized, double-blind, placebo-controlled study with long term extension
Number of treatment arms in the trial: 3
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Phase:
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Countries of recruitment
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Belgium
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Bulgaria
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Canada
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Czech Republic
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Estonia
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France
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Greece
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Hungary
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Italy
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Mexico
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Netherlands
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Poland
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Russian Federation
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Slovakia
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Spain
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Switzerland
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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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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
CH-6300
Zug
Switzerland |
Telephone:
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900850153 |
Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Name:
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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
CH-6300
Zug
Switzerland |
Telephone:
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900850153 |
Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Subject has provided informed consent - Subject is ? 18 years of age at time of screening - Subject has had a diagnosis of psoriatic arthritis for at least 6 months and currently meets the CASPAR criteria - Subject has ? 3 tender and ? 3 swollen joints - Subject has a history of intolerance or inadequate response to NSAIDs and/or DMARDs for psoriatic arthritis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria: Other Medical Conditions: - Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled. - Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Washouts or Other Treatments - Subject has used commercially available or investigational biologic therapies for psoriasis and/or psoriatic arthritis as follows: ? anti-tumor necrosis factor (TNF) therapy within 2 months prior to investigational product initiation ? other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months prior to investigational product initiation ? anti-IL17 or anti-IL12/IL23 biologic therapy, including brodalumab, secukinumab, ixekizumab, ustekinumab, briakinumab at any time ? rituximab at any time
General - Subject is currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to screening. - Other investigational procedures while participating in this study are excluded. - Subject has known sensitivity to any of the products or components to be administered during dosing. - Women of reproductive potential who are not willing to use an acceptable form of birth control during the study and for an additional 8 weeks after the last dose of study drug. - Women who are lactating/breastfeeding or planning to breastfeed during the study and for an additional 8 weeks after the last dose of Amgen study drug.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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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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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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Product Name: brodalumab (140 mg/ml) Product Code: AMG 827 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: brodalumab CAS Number: 1174395-19-7 Current Sponsor code: AMG 827 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 140- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Product Name: brodalumab (70mg/0.5ml) Product Code: AMG 827 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: brodalumab CAS Number: 1174395-19-7 Current Sponsor code: AMG 827 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 140- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 16
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Secondary Objective: Key Secondary Objectives: To evaluate the efficacy of brodalumab compared to placebo on the following: ? Psoriasis Area and Severity Index (PASI) 75 at week 16 ? Van der Heijde modified Total Sharp score (mTSS) at week 24
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Main Objective: To evaluate the efficacy of brodalumab, (210 mg every 2 weeks (Q2W); and 140 mg Q2W) compared to placebo, in subjects with psoriatic arthritis, as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response at week 16.
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Primary end point(s): ACR20 response at week 16
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Secondary Outcome(s)
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Secondary end point(s): Key secondary Endpoints: PASI 75 at week 16 mTSS change from baseline at week 24
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Timepoint(s) of evaluation of this end point: PASI 75 at week 16 mTSS change from baseline at week 24
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Secondary ID(s)
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20090406
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2013-003554-25-GR
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Source(s) of Monetary Support
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Amgen Inc
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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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