Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis
NCT ID: NCT01850680
Last Updated: 2014-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2013-04-30
2013-12-31
Brief Summary
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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.
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Detailed Description
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1. Screening: 3 to 28 days
2. Treatment: 1 day
3. Follow-up: 57± 3 days after dosing
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous
methotrexate
Pharmaceutical form:capsule Route of administration: oral
folic acid
Pharmaceutical form:tablet Route of administration: oral
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
sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous
methotrexate
Pharmaceutical form:capsule Route of administration: oral
folic acid
Pharmaceutical form:tablet Route of administration: oral
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
sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous
methotrexate
Pharmaceutical form:capsule Route of administration: oral
folic acid
Pharmaceutical form:tablet Route of administration: oral
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
sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous
methotrexate
Pharmaceutical form:capsule Route of administration: oral
folic acid
Pharmaceutical form:tablet Route of administration: oral
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
65 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 392001
Sendai, , Japan
Investigational Site Number 392002
Sendai, , Japan
Countries
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Other Identifiers
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U1111-1134-0048
Identifier Type: OTHER
Identifier Source: secondary_id
TDU13402
Identifier Type: -
Identifier Source: org_study_id
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