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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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19 March 2012 |
Main ID: |
EUCTR2005-001319-23-IT |
Date of registration:
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30/09/2005 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy
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Scientific title:
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A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy |
Date of first enrolment:
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21/10/2005 |
Target sample size:
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Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001319-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Hungary
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Italy
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Spain
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Key inclusion & exclusion criteria
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Inclusion criteria: 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Rheumatoid arthritis MedDRA version: 6.1
Level: PT
Classification code 10039073
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Intervention(s)
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Product Name: ERB-041 Product Code: ERB-041 Pharmaceutical Form: Capsule, hard CAS Number: 524684-52-4 Current Sponsor code: ERB-041 Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-
Product Name: ERB-041 Product Code: ERB-041 Pharmaceutical Form: Capsule, hard CAS Number: 524684-52-4 Current Sponsor code: ERB-041 Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
Product Name: ERB-041 Product Code: ERB-041 Pharmaceutical Form: Capsule, hard CAS Number: 524684-52-4 Current Sponsor code: ERB-041 Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75-
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Primary Outcome(s)
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Primary end point(s):
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Secondary Objective:
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Main Objective:
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Secondary ID(s)
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3142A1-202-WW
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2005-001319-23-HU
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Source(s) of Monetary Support
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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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