Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404558
• Other study ID #: PDY14191
• Secondary ID: U1111-1163-1359
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2015
• Last updated: March 25, 2016
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: Subcutaneous injection
• tocilizumab
Pharmaceutical form:solution Route of administration: Subcutaneous injection

Locations

Country	Name	City	State
Japan	Investigational Site Number 392001	Sendai-Shi
Japan	Investigational Site Number 392002	Sendai-Shi
Japan	Investigational Site Number 392003	Sendai-Shi

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with adverse events		6 weeks	Yes
Primary	Percentage of patients with potentially clinically significant laboratory abnormalities		6 weeks	Yes
Primary	Change from baseline in laboratory parameters (hematology and biochemistry)		Baseline, Day 15	Yes
Primary	Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)		Baseline, Day 15	Yes
Secondary	Assessment of PK parameter: maximum concentration (Cmax)		Day 1 to Day 43	No
Secondary	Assessment of PK parameter: time to Cmax (tmax)		Day 1 to Day 43	No
Secondary	Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)		Day 1 to Day 43	No
Secondary	Change from baseline in laboratory parameters (hematology and biochemistry)		Baseline, Day 29 and Day 43	Yes
Secondary	Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)		Baseline, Day 29 and Day 43	Yes