FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000074-31-SE
Enrollment
150
Registered
2004-05-21
Start date
2004-07-06
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis MedDRA version: 7.0 Level: LLT Classification code 10039073

Interventions

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- Pharmaceuti
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- Pharmaceuti
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- Pharmaceuti

Sponsors

Merck Sharp & Dohme (Sweden) AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate the clinical efficacy of L-000124467 in the treatment of rheumatoid arthritis.;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.;Primary end point(s): Swollen joint count—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026