Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
sarilumab SAR153191 (REGN88)
tocilizumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
- Investigational Site Number 392001
- Investigational Site Number 392002
- Investigational Site Number 392003
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sarilumab
Tocilizumab
Arm Description
Single subcutaneous (SC) dose of sarilumab
Single SC dose of tocilizumab
Outcomes
Primary Outcome Measures
Percentage of patients with adverse events
Percentage of patients with potentially clinically significant laboratory abnormalities
Change from baseline in laboratory parameters (hematology and biochemistry)
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Secondary Outcome Measures
Assessment of PK parameter: maximum concentration (Cmax)
Assessment of PK parameter: time to Cmax (tmax)
Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)
Change from baseline in laboratory parameters (hematology and biochemistry)
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Full Information
NCT ID
NCT02404558
First Posted
March 26, 2015
Last Updated
March 25, 2016
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02404558
Brief Title
Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sarilumab
Arm Type
Experimental
Arm Description
Single subcutaneous (SC) dose of sarilumab
Arm Title
Tocilizumab
Arm Type
Active Comparator
Arm Description
Single SC dose of tocilizumab
Intervention Type
Drug
Intervention Name(s)
sarilumab SAR153191 (REGN88)
Intervention Description
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
tocilizumab
Intervention Description
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of patients with adverse events
Time Frame
6 weeks
Title
Percentage of patients with potentially clinically significant laboratory abnormalities
Time Frame
6 weeks
Title
Change from baseline in laboratory parameters (hematology and biochemistry)
Time Frame
Baseline, Day 15
Title
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Time Frame
Baseline, Day 15
Secondary Outcome Measure Information:
Title
Assessment of PK parameter: maximum concentration (Cmax)
Time Frame
Day 1 to Day 43
Title
Assessment of PK parameter: time to Cmax (tmax)
Time Frame
Day 1 to Day 43
Title
Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)
Time Frame
Day 1 to Day 43
Title
Change from baseline in laboratory parameters (hematology and biochemistry)
Time Frame
Baseline, Day 29 and Day 43
Title
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Time Frame
Baseline, Day 29 and Day 43
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 392001
City
Sendai-Shi
Country
Japan
Facility Name
Investigational Site Number 392002
City
Sendai-Shi
Country
Japan
Facility Name
Investigational Site Number 392003
City
Sendai-Shi
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32453485
Citation
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.
Results Reference
derived
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Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis
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