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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

sarilumab SAR153191 (REGN88)

placebo

methotrexate

folic acid

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

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:
1. Etanercept: within 28 days prior to randomization
2. 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.

Sites / Locations

Investigational Site Number 392001
Investigational Site Number 392002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Sarilumab (SAR153191, REGN88) Dose 1

Sarilumab (SAR153191, REGN88) Dose 2

Sarilumab (SAR153191, REGN88) Dose 3

Sarilumab (SAR153191, REGN88) Dose 4

Placebo Dose 5

Arm Description

First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Outcomes

Primary Outcome Measures

Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)

Assessment of the occurrence of anti-sarilumab antibodies

Assessment of the titer of anti-sarilumab antibodies

Secondary Outcome Measures

Assessment of PK parameter - maximum concentration (Cmax)

Assessment of PK parameter - area under curve (AUC)

Assessment of PK parameter - time to maximum concentration (tmax)

Full Information

NCT ID

NCT01850680

First Posted

May 1, 2013

Last Updated

January 27, 2014

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01850680

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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 Screening: 3 to 28 days Treatment: 1 day Follow-up: 57± 3 days after dosing

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sarilumab (SAR153191, REGN88) Dose 1

Arm Type

Experimental

Arm Description

First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Arm Title

Sarilumab (SAR153191, REGN88) Dose 2

Arm Type

Experimental

Arm Description

Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Arm Title

Sarilumab (SAR153191, REGN88) Dose 3

Arm Type

Experimental

Arm Description

Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Arm Title

Sarilumab (SAR153191, REGN88) Dose 4

Arm Type

Experimental

Arm Description

Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Arm Title

Placebo Dose 5

Arm Type

Placebo Comparator

Arm Description

Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy

Intervention Type

Drug

Intervention Name(s)

sarilumab SAR153191 (REGN88)

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Description

Pharmaceutical form:capsule Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

folic acid

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Primary Outcome Measure Information:

Title

Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)

Time Frame

Up to 88 days or end-of-study (EoS)

Title

Assessment of the occurrence of anti-sarilumab antibodies

Time Frame

Day 1, Day 15, Day 29, Day 57

Title

Assessment of the titer of anti-sarilumab antibodies

Time Frame

Day 1, Day 15, Day 29, Day 57

Secondary Outcome Measure Information:

Title

Assessment of PK parameter - maximum concentration (Cmax)

Time Frame

At each visit, up to 88 days

Title

Assessment of PK parameter - area under curve (AUC)

Time Frame

At each visit, up to 88 days

Title

Assessment of PK parameter - time to maximum concentration (tmax)

Time Frame

At each visit, up to 88 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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 Exclusion criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 392001

City

Sendai-Shi

Country

Japan

Facility Name

Investigational Site Number 392002

City

Sendai-Shi

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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