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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)

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02097524
Collaborator
Sanofi (Industry)
105
Enrollment
19
Locations
4
Arms
13
Duration (Months)
5.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

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:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. PD parameters [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 Outcome Measures

    1. Percentage of TEAEs [baseline through week 6]

      Percentage of patients with treatment-emergent adverse events (TEAEs) from baseline through end of study (week 6).

    2. PK parameters [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States
    2 Orange California United States
    3 Deland Florida United States
    4 Edgewater Florida United States
    5 Miami Lakes Florida United States
    6 Miami Florida United States
    7 Granger Indiana United States
    8 Grand Blanc Michigan United States
    9 Charlotte North Carolina United States
    10 Cinicinnati Ohio United States
    11 Memphis Tennessee United States
    12 Austin Texas United States
    13 Carrollton Texas United States
    14 Channelview Texas United States
    15 Dallas Texas United States
    16 Houston Texas United States
    17 Mesquite Texas United States
    18 Plano Texas United States
    19 San Antonio Texas United States

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals
    • Sanofi

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02097524
    Other Study ID Numbers:
    • 6R88-RA-1309
    First Posted:
    Mar 27, 2014
    Last Update Posted:
    May 5, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of May 5, 2015