Rheumatoid Arthritis
Conditions
Brief summary
Primary Objective: To assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant treatment with methotrexate. Secondary Objective: To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in Japanese RA patients.
Detailed description
Total study duration per patient is up to 88 days 1. Screening: 3 to 28 days 2. Treatment: 1 day 3. Follow-up: 57± 3 days after dosing
Interventions
Pharmaceutical form:solution Route of administration: subcutaneous
DRUGplacebo
Pharmaceutical form:solution Route of administration: subcutaneous
DRUGmethotrexate
Pharmaceutical form:capsule Route of administration: oral
DRUGfolic acid
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female Japanese who are 20 to 65 years of age 2. Diagnosis of rheumatoid arthritis (RA) ≥ 3 months duration 3. Treated for a minimum of 8 weeks with Methotrexate (MTX) and with a stable dose of MTX (6-16 mg/week) for a minimum of 4 weeks prior to the screening visit
Exclusion criteria
1. Autoimmune or inflammatory systemic or localized joint disease other than RA 2. Women of a positive pregnancy test 3. Latent or active tuberculosis 4. Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist 5. Treatment with anti-TNF agents, as follows: 1. Etanercept: within 28 days prior to randomization 2. Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization 6. Received any live, attenuated vaccine within 3 months prior to the randomization visit (eg, varicella-zoster, oral polio, rubella vaccines) 7. Significant concomitant illness such as, but not limited to, cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepato-biliary, metabolic, pulmonary or lymphatic disease that would adversely affect the patient's participation in the study. 8. Received surgery within 4 weeks prior to the screening visit or planned surgery during the study 9. History of a systemic hypersensitivity reaction The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG) | Up to 88 days or end-of-study (EoS) |
| Assessment of the occurrence of anti-sarilumab antibodies | Day 1, Day 15, Day 29, Day 57 |
| Assessment of the titer of anti-sarilumab antibodies | Day 1, Day 15, Day 29, Day 57 |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of PK parameter - maximum concentration (Cmax) | At each visit, up to 88 days |
| Assessment of PK parameter - area under curve (AUC) | At each visit, up to 88 days |
| Assessment of PK parameter - time to maximum concentration (tmax) | At each visit, up to 88 days |
Countries
Japan
Outcome results
None listed