Rheumatoid Arthritis
Conditions
Brief summary
Primary Objective: To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA). Secondary Objectives: To describe the laboratory abnormalities (absolute neutrophil count \[ANC\], platelet counts, total cholesterol, high-density lipoprotein \[HDL\] cholesterol, low-density lipoprotein \[LDL\] cholesterol, and liver function tests \[LFTs\]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA. To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.
Detailed description
Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).
Interventions
Pharmaceutical form:solution Route of administration: Subcutaneous injection
DRUGtocilizumab
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 * Rheumatoid Arthritis Classification Criteria. * ACR Class I-III functional status, based on the 1991 revised criteria.
Exclusion criteria
* Patients less than 20 years of age. * Prior treatment with any biologic anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6R) antagonist. * Any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization. * Treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization. * Treatment with disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents within a certain amount of time prior to randomization. * Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer. * Active or suspected tuberculosis (TB) or at high risk of contracting TB. * Fever, or chronic, persistent, or recurring infection(s) requiring active treatment. * 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 |
|---|---|
| Percentage of patients with adverse events | 6 weeks |
| Percentage of patients with potentially clinically significant laboratory abnormalities | 6 weeks |
| Change from baseline in laboratory parameters (hematology and biochemistry) | Baseline, Day 15 |
| Weighted average of change from baseline in laboratory parameters (hematology and biochemistry) | Baseline, Day 15 |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of PK parameter: maximum concentration (Cmax) | Day 1 to Day 43 |
| Weighted average of change from baseline in laboratory parameters (hematology and biochemistry) | Baseline, Day 29 and Day 43 |
| Assessment of PK parameter: time to Cmax (tmax) | Day 1 to Day 43 |
| Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast) | Day 1 to Day 43 |
| Change from baseline in laboratory parameters (hematology and biochemistry) | Baseline, Day 29 and Day 43 |
Countries
Japan
Outcome results
None listed