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

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ClinicalTrials.gov Identifier: NCT01850680
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : January 28, 2014
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: sarilumab SAR153191 (REGN88) Drug: placebo Drug: methotrexate Drug: folic acid Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: methotrexate
Pharmaceutical form:capsule Route of administration: oral

Drug: folic acid
Pharmaceutical form:tablet Route of administration: oral

Experimental: 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
Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: methotrexate
Pharmaceutical form:capsule Route of administration: oral

Drug: folic acid
Pharmaceutical form:tablet Route of administration: oral

Experimental: 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
Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: methotrexate
Pharmaceutical form:capsule Route of administration: oral

Drug: folic acid
Pharmaceutical form:tablet Route of administration: oral

Experimental: 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
Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: methotrexate
Pharmaceutical form:capsule Route of administration: oral

Drug: folic acid
Pharmaceutical form:tablet Route of administration: oral

Placebo Comparator: 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
Drug: placebo
Pharmaceutical form:solution Route of administration: subcutaneous

Drug: methotrexate
Pharmaceutical form:capsule Route of administration: oral

Drug: folic acid
Pharmaceutical form:tablet Route of administration: oral




Primary Outcome Measures :
  1. Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG) [ Time Frame: Up to 88 days or end-of-study (EoS) ]
  2. Assessment of the occurrence of anti-sarilumab antibodies [ Time Frame: Day 1, Day 15, Day 29, Day 57 ]
  3. Assessment of the titer of anti-sarilumab antibodies [ Time Frame: Day 1, Day 15, Day 29, Day 57 ]

Secondary Outcome Measures :
  1. Assessment of PK parameter - maximum concentration (Cmax) [ Time Frame: At each visit, up to 88 days ]
  2. Assessment of PK parameter - area under curve (AUC) [ Time Frame: At each visit, up to 88 days ]
  3. Assessment of PK parameter - time to maximum concentration (tmax) [ Time Frame: At each visit, up to 88 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850680


Locations
Japan
Investigational Site Number 392001
Sendai-Shi, Japan
Investigational Site Number 392002
Sendai-Shi, Japan
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01850680     History of Changes
Other Study ID Numbers: TDU13402
U1111-1134-0048 ( Other Identifier: UTN )
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Folic Acid
Vitamin B Complex
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Hematinics
Vitamins
Micronutrients
Growth Substances