Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis
An Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid Arthritis
2 other identifiers
interventional
30
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 rheumatoid-arthritis
Started May 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 28, 2016
March 1, 2016
10 months
March 26, 2015
March 25, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
Assessment of PK parameter: maximum concentration (Cmax)
Day 1 to 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
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Baseline, Day 29 and Day 43
Study Arms (2)
Sarilumab
EXPERIMENTALSingle subcutaneous (SC) dose of sarilumab
Tocilizumab
ACTIVE COMPARATORSingle SC dose of tocilizumab
Interventions
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (3)
Investigational Site Number 392001
Sendai, Japan
Investigational Site Number 392002
Sendai, Japan
Investigational Site Number 392003
Sendai, Japan
Related Publications (1)
Kovalenko P, Paccaly A, Boyapati A, Xu C, St John G, Nivens MC, Davis JD, Rippley R, DiCioccio AT. Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis. CPT Pharmacometrics Syst Pharmacol. 2020 Jul;9(7):405-416. doi: 10.1002/psp4.12534. Epub 2020 Jun 20.
PMID: 32453485DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
March 31, 2015
Study Start
May 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 28, 2016
Record last verified: 2016-03