Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 25 for:    "sarilumab" AND "Rheumatoid Arthritis"
Previous Study | Return to List | Next Study

Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02404558
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : March 28, 2016
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Primary Objective:

To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA).

Secondary Objectives:

To describe the laboratory abnormalities (absolute neutrophil count [ANC], platelet counts, total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, and liver function tests [LFTs]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA.

To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: sarilumab SAR153191 (REGN88) Drug: tocilizumab Phase 1

Detailed Description:
Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid Arthritis
Study Start Date : May 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Sarilumab
Single subcutaneous (SC) dose of sarilumab
 Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: Subcutaneous injection
Active Comparator: Tocilizumab
Single SC dose of tocilizumab
 Drug: tocilizumab
Pharmaceutical form:solution Route of administration: Subcutaneous injection


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of patients with adverse events [ Time Frame: 6 weeks ]
  2. Percentage of patients with potentially clinically significant laboratory abnormalities [ Time Frame: 6 weeks ]
  3. Change from baseline in laboratory parameters (hematology and biochemistry) [ Time Frame: Baseline, Day 15 ]
  4. Weighted average of change from baseline in laboratory parameters (hematology and biochemistry) [ Time Frame: Baseline, Day 15 ]

Secondary Outcome Measures :
  1. Assessment of PK parameter: maximum concentration (Cmax) [ Time Frame: Day 1 to Day 43 ]
  2. Assessment of PK parameter: time to Cmax (tmax) [ Time Frame: Day 1 to Day 43 ]
  3. Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast) [ Time Frame: Day 1 to Day 43 ]
  4. Change from baseline in laboratory parameters (hematology and biochemistry) [ Time Frame: Baseline, Day 29 and Day 43 ]
  5. Weighted average of change from baseline in laboratory parameters (hematology and biochemistry) [ Time Frame: Baseline, Day 29 and Day 43 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010
  • Rheumatoid Arthritis Classification Criteria.
  • ACR Class I-III functional status, based on the 1991 revised criteria.

Exclusion criteria:

  • Patients less than 20 years of age.
  • Prior treatment with any biologic anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6R) antagonist.
  • Any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.
  • Treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
  • Treatment with disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents within a certain amount of time 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.
  • Active or suspected tuberculosis (TB) or at high risk of contracting TB.
  • Fever, or chronic, persistent, or recurring infection(s) requiring active treatment.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404558


Locations
Layout table for location information
Japan
Investigational Site Number 392001
Sendai-Shi, Japan
Investigational Site Number 392002
Sendai-Shi, Japan
Investigational Site Number 392003
Sendai-Shi, Japan
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02404558    
Other Study ID Numbers: PDY14191
U1111-1163-1359 ( Other Identifier: UTN )
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases