Trial record 2 of 47 for:    regeneron | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02097524
First received: March 3, 2014
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Sarilumab
Drug: Tocilizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • PD parameters [ Time Frame: baseline through week 4 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Percentage of TEAEs [ Time Frame: baseline through week 6 ] [ Designated as safety issue: Yes ]
    Percentage of patients with treatment-emergent adverse events (TEAEs) from baseline through end of study (week 6).

  • PK parameters [ Time Frame: baseline through week 4 ] [ Designated as safety issue: No ]

    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)


Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • REGN88
  • SAR153191
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:
  • REGN88
  • SAR153191
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with RA as defined by the 2010 revised American College of Rheumatology (ACR)
  2. ACR Class I-II 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097524

Contacts
Contact: Clinical Trials Administrator clinicaltrial@regeneron.com

Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
United States, California
Recruiting
Orange, California, United States
United States, Florida
Recruiting
Deland, Florida, United States
Recruiting
Edgewater, Florida, United States
Recruiting
Miami, Florida, United States
Recruiting
Miami Lakes, Florida, United States
United States, Indiana
Recruiting
Granger, Indiana, United States
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States
United States, Ohio
Recruiting
Cinicinnati, Ohio, United States
United States, Texas
Recruiting
Austin, Texas, United States
Recruiting
Carrollton, Texas, United States
Recruiting
Channelview, Texas, United States
Recruiting
Dallas, Texas, United States
Recruiting
Houston, Texas, United States
Recruiting
Mesquite, Texas, United States
Recruiting
Plano, Texas, United States
Recruiting
San Antonio, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02097524     History of Changes
Other Study ID Numbers: 6R88-RA-1309
Study First Received: March 3, 2014
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014