Skip to main content
OpenTrials
Completed

NCT Number: NCT02097524

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

The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with RA as defined by the 2010 revised American College of Rheumatology (ACR)
  • ACR Class I-III functional status, based on the 1991 revised criteria
  • 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

  • Patients less than 18 years of age or minimum legal age
  • Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R) antagonists
  • Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
  • 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
  • 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
  • Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other than MTX, within a certain amount of time prior to screening visit
  • Active or suspected TB or at high risk of contracting TB
  • Fever, or chronic, persistent, or recurring infections requiring active treatment
  • 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.

Treatment and study plan

Sarilumab

Drug

Other names: REGN88, SAR153191

Tocilizumab

Drug

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. 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)

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2014
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.