Rheumatoid Arthritis MedDRA version: 7.0 Level: LLT Classification code 10039073
Conditions
Interventions
Product Name: L-000883191
Product Code: L-000883191
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg millig
Sponsors
Suomen MSD Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient understands the study procedures and agrees to participate in the study by giving written informed consent. Patient has satisfied (for RA diagnosis) at least 4 of 7 ARA 1987 revised criteria for the diagnosis of RA sometime in the past (see Appendix 2). Patient has active RA with a minimum level of disease activity at both Visit 1 and Visit 2, 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 28, a CRP of at least 2.0 mg/dL (SI units: ³20.0 mg/L) or morning stiffness that lasts at least 45 minutes. 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: Patient has any history of conduction system abnormality or arrhythmia, including but not limited to an abnormal QTc (>440 msec) or prolonged QRS (QRS >120 msec) or prolonged PR (>200 msec) interval on the Visit 1.0 ECG. Patients noted to have a QTc interval of > 440 msec at any later point in the study will be removed from the study. For patients who do not have a history of tuberculosis, an intradermal PPD test will be administered at the screening visit. A patient with a PPD test result of 10 mm will be excluded from the study regardless of radiographic findings. For patients on immunosuppressive therapy (e.g., methotrexate, leflunomide or steroids) at the time of testing, a cutoff of 5 mm should be used. Patients who have had a PPD result of <5 mm within the previous 3 months (prior to enrollment) and have had no pulmonary symptoms since the time of this test, need not repeat this test. It is acknowledged that screening procedures for TB vary from region to region worldwide. In regions where published local guidelines for the screening of patients for TB exist, those guidelines should be reviewed and the most conservative approach (either that outlined in this study or those recommended by published local guidelines) should be followed. • Except for patients with a recent chest x-ray (£3 months [which has been read as negative and is available for review]; and have had no pulmonary symptoms since the time of the film), all patients should have a chest x-ray at the time of screening. Patient has evidence of any acute or chronic gastrointestinal disease documented by history, physical examination, radiography or scans, and / or laboratory values. This includes a history of complicated peptic ulcer disease, Crohn disease, ulcerative colitis, proctitis, mesenteric arteritis or enteritis as well as unexplained diarrhea, bloody or mucoid stools, loose stools, nausea, vomiting, dyspepsia, or abdominal pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the clinical efficacy of L-000883191 1.25 mg twice daily in the treatment of rheumatoid arthritis;Secondary Objective: To demonstrate the safety and tolerability of L000883191 in RA patients;Primary end point(s): Swollen joint counts based on the average responses across Weeks 8, 10, and 12 including discontinuation visits | — |
Countries
Czech Republic, Finland, Germany, Italy, Spain
Outcome results
None listed