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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. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2004-000074-31-BE |
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Date of registration:
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07/07/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis
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Scientific title:
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A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis |
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Date of first enrolment:
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15/03/2005 |
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Target sample size:
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150 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000074-31 |
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Study type:
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Interventional clinical trial of medicinal product |
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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: paracetamol (acetaminophen) tablets - Rescue Medication)
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients’ diagnosis of rheumatoid disease must meet or have met 1987 ARA revised diagnostic criteria. Patients must have active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints, a Patient Global Assessment of Disease Activity of >40 mm (on a 100-mm Visual Analog Scale [VAS]), an Investigator Global Assessment of Disease Activity of fair, poor, or very poor (on a 5-point Likert scale), and 1 of the following: an ESR greater than or equal to 26, a CRP of at least 2.0 mg/dL (SI units: ³20.0 mg/L) or morning stiffness that lasts at least 45 minutes at Visits 1.0 and Visit 2.0.
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Patients will undergo tuberculin purified protein derivative (PPD) testing prior to randomization in to the study. Patients with evidence of on-going or previous tuberculosis (TB) infection will not be eligible for participation in the study.
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: 7.0
Level: LLT
Classification code 10039073
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Intervention(s)
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Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467-009J (succinat
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Other descriptive name: L-000124467
Concentration unit: mg milligram(s)
Concentration number: 0.2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467-009J (succinat
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Other descriptive name: L-000124467
Concentration unit: mg milligram(s)
Concentration number: 1.0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467-009J (succinat
Pharmaceutical Form: Tablet
INN or Proposed INN: not available
Other descriptive name: L-000124467
Concentration unit: mg milligram(s)
Concentration number: 5.0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: paracetamol (acetaminophen)
Product Name: paracetamol (acetaminophen)
Pharmaceutical Form: Tablet
CAS Number: 103-90-2
Concentration unit: mg milligram(s)
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Primary Outcome(s)
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Primary end point(s): Swollen joint count
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Main Objective: To demonstrate the clinical efficacy of L-000124467 in the treatment of rheumatoid arthritis.
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Secondary Objective: To demonstrate the safety and tolerability of L-000124467 0.4 and 10.0 mg once daily for 12 weeks in RA patients.
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Secondary ID(s)
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2004-000074-31-SE
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0812-008
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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