Rheumatoid Arthritis MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of rheumatoid arthitis RA = 3 months. Moderately to severely active rheumatoid arthritis. Patients who per Investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combnation of non-biologic disease modifying anti-rheumatic drugs (DMARDs). 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Patients 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization. New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to randomization, except for the use of low-dose acetylsalicylic acid for cardiovasculaire diseases. Use of parenteral glucocorticoids or intra-articular glucocorticoids injection within 4 weeks prior to randomization. Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib). New treatment or dose-adjustment to on-going medication for dyslipidemia, such as statin, within 6 weeks prior to randomization. Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first dose of study drug administration, whichever is longer. Patients with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randimization visit. Nonmalignant lymphoproliferative disorders are also excluded. Patients with active tuberculosis or untreated latent tuberculosis infection. Pregnant or breast feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. ;Secondary Objective: To evaluate the other safety aspects of sarilumab administered as monotherapy. To assess the exposure of sarilumab administered as monotherapy. ;Primary end point(s): The incidence of anti-drug antibody (ADA) from baseline.;Timepoint(s) of evaluation of this end point: Up to 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety as assessed by adverse events/serious adverse events, vital signs, physical examinations, clinical laboratory, ECGs from baseline. Sarilumab exposure assessed by pre-dose serum sarilumab concentrations from baseline.;Timepoint(s) of evaluation of this end point: Up to 24 weeks. | — |
Countries
Argentina, Chile, Czech Republic, Estonia, Hungary, Poland, Russian Federation, United States
Contacts
Public ContactNA.
sanofi-aventis Zrt.
Outcome results
None listed