Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: sarilumab SAR153191 (REGN88); Drug: placebo; Drug: methotrexate; Drug: folic acid

• Registration Number: NCT01850680
• Lead Sponsor: Sanofi

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarilumab (SAR153191, REGN88) Dose 2	sarilumab SAR153191 (REGN88)	Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 1	sarilumab SAR153191 (REGN88)	First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 3	sarilumab SAR153191 (REGN88)	Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 3	methotrexate	Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 4	sarilumab SAR153191 (REGN88)	Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Placebo Dose 5	placebo	Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Placebo Dose 5	folic acid	Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 1	folic acid	First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 1	methotrexate	First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 2	methotrexate	Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 2	folic acid	Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 3	folic acid	Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 4	methotrexate	Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Placebo Dose 5	methotrexate	Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Sarilumab (SAR153191, REGN88) Dose 4	folic acid	Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Investigational Site Number 392002; 🇯🇵 Sendai-Shi, Japan

Investigational Site Number 392001; 🇯🇵 Sendai-Shi, Japan