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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850680
• Other study ID #: TDU13402
• Secondary ID: U1111-1134-0048
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2013
• Last updated: January 27, 2014
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion criteria:

1. Male or female Japanese who are 20 to 65 years of age

2. Diagnosis of rheumatoid arthritis (RA) = 3 months duration

3. 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:

1. Autoimmune or inflammatory systemic or localized joint disease other than RA

2. Women of a positive pregnancy test

3. Latent or active tuberculosis

4. Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist

5. 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

6. Received any live, attenuated vaccine within 3 months prior to the randomization visit (eg, varicella-zoster, oral polio, rubella vaccines)

7. 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.

8. Received surgery within 4 weeks prior to the screening visit or planned surgery during the study

9. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous
• placebo
Pharmaceutical form:solution Route of administration: subcutaneous
• methotrexate
Pharmaceutical form:capsule Route of administration: oral
• folic acid
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Japan	Investigational Site Number 392001	Sendai-Shi
Japan	Investigational Site Number 392002	Sendai-Shi

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)		Up to 88 days or end-of-study (EoS)	Yes
Primary	Assessment of the occurrence of anti-sarilumab antibodies		Day 1, Day 15, Day 29, Day 57	Yes
Primary	Assessment of the titer of anti-sarilumab antibodies		Day 1, Day 15, Day 29, Day 57	Yes
Secondary	Assessment of PK parameter - maximum concentration (Cmax)		At each visit, up to 88 days	No
Secondary	Assessment of PK parameter - area under curve (AUC)		At each visit, up to 88 days	No
Secondary	Assessment of PK parameter - time to maximum concentration (tmax)		At each visit, up to 88 days	No