Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)

May 4, 2015 updated by: Regeneron Pharmaceuticals
The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Orange, California, United States
    • Florida
      • Deland, Florida, United States
      • Edgewater, Florida, United States
      • Miami, Florida, United States
      • Miami Lakes, Florida, United States
    • Indiana
      • Granger, Indiana, United States
    • Michigan
      • Grand Blanc, Michigan, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Cinicinnati, Ohio, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Carrollton, Texas, United States
      • Channelview, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Mesquite, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with RA as defined by the 2010 revised American College of Rheumatology (ACR)
  2. ACR Class I-III functional status, based on the 1991 revised criteria
  3. Treated for a minimum of 12 weeks with Methotrexate with a stable dose of MTX for at least 8 weeks prior to screening visit

Exclusion Criteria:

  1. Patients less than 18 years of age or minimum legal age
  2. Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R) antagonists
  3. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
  4. Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to randomization
  5. 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
  6. Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other than MTX, within a certain amount of time prior to screening visit
  7. Active or suspected TB or at high risk of contracting TB
  8. Fever, or chronic, persistent, or recurring infections requiring active treatment
  9. HIV positive

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sarilumab - dose 1
Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Drug: Sarilumab
Other Names:
  • SAR153191
  • REGN88
Experimental: Sarilumab - dose 2
Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Drug: Sarilumab
Other Names:
  • SAR153191
  • REGN88
Active Comparator: Tocilizumab - dose 1
Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Drug: Tocilizumab
Active Comparator: Tocilizumab - dose 2
Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Drug: Tocilizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PD parameters
Time Frame: baseline through week 4

Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4:

  • the time to nadir (or peak)
  • change from baseline
  • area under the curve (AUC)
baseline through week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of TEAEs
Time Frame: baseline through week 6
Percentage of patients with treatment-emergent adverse events (TEAEs) from baseline through end of study (week 6).
baseline through week 6
PK parameters
Time Frame: baseline through week 4

Pharmacokinetic (PK) parameters, what the body does to a drug, will be collected from baseline through week 4:

  • AUC
  • CL (clearance)
  • Cmax (the peak concentration)
  • t1/2 (observed terminal half-life)
baseline through week 4

Collaborators and Investigators

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

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

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

March 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 27, 2014

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6R88-RA-1309

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.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Tocilizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe