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

Regeneron Pharmaceuticals logo

Regeneron Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: Tocilizumab
Drug: Sarilumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02097524
6R88-RA-1309

Details and patient eligibility

About

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

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 4 patient groups

Sarilumab - dose 1
Experimental group
Description:
Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Treatment:
Drug: Sarilumab
Sarilumab - dose 2
Experimental group
Description:
Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Treatment:
Drug: Sarilumab
Tocilizumab - dose 1
Active Comparator group
Description:
Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Treatment:
Drug: Tocilizumab
Tocilizumab - dose 2
Active Comparator group
Description:
Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Treatment:
Drug: Tocilizumab

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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