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

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT02097524

Run by

Regeneron Pharmaceuticals

People needed

105

Starts

2014-03-01

Expected to finish

2015-04-01

Last updated by the study team

2015-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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