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

March 25, 2016 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Sendai-Shi, Japan
        • Investigational Site Number 392001
      • Sendai-Shi, Japan
        • Investigational Site Number 392002
      • Sendai-Shi, Japan
        • Investigational Site Number 392003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sarilumab
Single subcutaneous (SC) dose of sarilumab
Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Active Comparator: Tocilizumab
Single SC dose of tocilizumab
Drug: tocilizumab
Pharmaceutical form:solution Route of administration: Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with adverse events
Time Frame: 6 weeks
6 weeks
Percentage of patients with potentially clinically significant laboratory abnormalities
Time Frame: 6 weeks
6 weeks
Change from baseline in laboratory parameters (hematology and biochemistry)
Time Frame: Baseline, Day 15
Baseline, Day 15
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Time Frame: Baseline, Day 15
Baseline, Day 15

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of PK parameter: maximum concentration (Cmax)
Time Frame: Day 1 to Day 43
Day 1 to Day 43
Assessment of PK parameter: time to Cmax (tmax)
Time Frame: Day 1 to Day 43
Day 1 to Day 43
Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)
Time Frame: Day 1 to Day 43
Day 1 to Day 43
Change from baseline in laboratory parameters (hematology and biochemistry)
Time Frame: Baseline, Day 29 and Day 43
Baseline, Day 29 and Day 43
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
Time Frame: Baseline, Day 29 and Day 43
Baseline, Day 29 and Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Estimate)

March 28, 2016

Last Update Submitted That Met QC Criteria

March 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDY14191
  • U1111-1163-1359 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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