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
Overview
- Phase
- Phase 1
- Intervention
- sarilumab SAR153191 (REGN88)
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Sanofi
- Enrollment
- 61
- Locations
- 2
- Primary Endpoint
- Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Detailed Description
Total study duration per patient is up to 88 days 1. Screening: 3 to 28 days 2. Treatment: 1 day 3. Follow-up: 57± 3 days after dosing
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sarilumab (SAR153191, REGN88) Dose 1
First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: sarilumab SAR153191 (REGN88)
Sarilumab (SAR153191, REGN88) Dose 1
First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: methotrexate
Sarilumab (SAR153191, REGN88) Dose 1
First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: folic acid
Sarilumab (SAR153191, REGN88) Dose 2
Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: sarilumab SAR153191 (REGN88)
Sarilumab (SAR153191, REGN88) Dose 2
Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: methotrexate
Sarilumab (SAR153191, REGN88) Dose 2
Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: folic acid
Sarilumab (SAR153191, REGN88) Dose 3
Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: sarilumab SAR153191 (REGN88)
Sarilumab (SAR153191, REGN88) Dose 3
Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: methotrexate
Sarilumab (SAR153191, REGN88) Dose 3
Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: folic acid
Sarilumab (SAR153191, REGN88) Dose 4
Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: sarilumab SAR153191 (REGN88)
Sarilumab (SAR153191, REGN88) Dose 4
Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: methotrexate
Sarilumab (SAR153191, REGN88) Dose 4
Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: folic acid
Placebo Dose 5
Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: placebo
Placebo Dose 5
Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: methotrexate
Placebo Dose 5
Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Intervention: folic acid
Outcomes
Primary Outcomes
Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)
Time Frame: Up to 88 days or end-of-study (EoS)
Assessment of the occurrence of anti-sarilumab antibodies
Time Frame: Day 1, Day 15, Day 29, Day 57
Assessment of the titer of anti-sarilumab antibodies
Time Frame: Day 1, Day 15, Day 29, Day 57
Secondary Outcomes
- 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)