Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant Methotrexate
2 other identifiers
interventional
61
1 country
2
Brief Summary
Primary Objective: To assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant treatment with methotrexate. Secondary Objective: To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in Japanese RA patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 rheumatoid-arthritis
Started Apr 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 28, 2014
January 1, 2014
8 months
May 1, 2013
January 27, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)
Up to 88 days or end-of-study (EoS)
Assessment of the occurrence of anti-sarilumab antibodies
Day 1, Day 15, Day 29, Day 57
Assessment of the titer of anti-sarilumab antibodies
Day 1, Day 15, Day 29, Day 57
Secondary Outcomes (3)
Assessment of PK parameter - maximum concentration (Cmax)
At each visit, up to 88 days
Assessment of PK parameter - area under curve (AUC)
At each visit, up to 88 days
Assessment of PK parameter - time to maximum concentration (tmax)
At each visit, up to 88 days
Study Arms (5)
Sarilumab (SAR153191, REGN88) Dose 1
EXPERIMENTALFirst dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 2
EXPERIMENTALSecond dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 3
EXPERIMENTALThird dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 4
EXPERIMENTALFourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Placebo Dose 5
PLACEBO COMPARATORPlacebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Interventions
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:capsule Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Eligibility Criteria
You may qualify if:
- Male or female Japanese who are 20 to 65 years of age
- Diagnosis of rheumatoid arthritis (RA) ≥ 3 months duration
- Treated for a minimum of 8 weeks with Methotrexate (MTX) and with a stable dose of MTX (6-16 mg/week) for a minimum of 4 weeks prior to the screening visit
You may not qualify if:
- Autoimmune or inflammatory systemic or localized joint disease other than RA
- Women of a positive pregnancy test
- Latent or active tuberculosis
- Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist
- Treatment with anti-TNF agents, as follows:
- Etanercept: within 28 days prior to randomization
- Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization
- Received any live, attenuated vaccine within 3 months prior to the randomization visit (eg, varicella-zoster, oral polio, rubella vaccines)
- Significant concomitant illness such as, but not limited to, cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepato-biliary, metabolic, pulmonary or lymphatic disease that would adversely affect the patient's participation in the study.
- Received surgery within 4 weeks prior to the screening visit or planned surgery during the study
- History of a systemic hypersensitivity reaction
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (2)
Investigational Site Number 392001
Sendai, Japan
Investigational Site Number 392002
Sendai, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 9, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 28, 2014
Record last verified: 2014-01