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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sarilumab

Single subcutaneous (SC) dose of sarilumab

Group Type EXPERIMENTAL

sarilumab SAR153191 (REGN88)

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Tocilizumab

Single SC dose of tocilizumab

Group Type ACTIVE_COMPARATOR

tocilizumab

Intervention Type DRUG

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Interventions

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sarilumab SAR153191 (REGN88)

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Intervention Type DRUG

tocilizumab

Pharmaceutical form:solution Route of administration: Subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No