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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02121210
Other study ID # EFC13752
Secondary ID 2013-002790-22U1
Status Completed
Phase Phase 3
First received April 21, 2014
Last updated January 6, 2016
Start date June 2014
Est. completion date May 2015

Study information

Verified date January 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Primary Objective:

To evaluate the immunogenicity of sarilumab administered as monotherapy.

Secondary Objectives:

- To evaluate the other safety aspects of sarilumab administered as monotherapy.

- To assess the exposure of sarilumab administered as monotherapy.


Description:

Total study duration is up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, patients are eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 [REGN88]).


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Diagnosis of rheumatoid arthritis (RA) = 3 months.

- Moderately to severely active rheumatoid arthritis.

- Patients who per investigator judgment were incomplete responders to at least 12 weeks of an adequate dose of continuous treatment with or who were intolerant of one or a combination of non-biologic disease modifying anti-rheumatic drugs (DMARDs).

Exclusion criteria:

- Patients < 18 years of age.

- Past history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than RA.

- History of juvenile idiopathic arthritis or arthritis onset prior to age 16.

- Severe active systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.

- Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonist therapies.

- Treatment with prednisone > 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.

- New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to randomization, except for the use of low-dose acetylsalicylic acid for cardiovascular diseases.

- Use of parenteral glucocorticoids or intraarticular glucocorticoids injection within 4 weeks prior to randomization.

- Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib).

- New treatment or dose-adjustment to on-going medication for dyslipidemia, such as statin, within 6 weeks prior to randomization.

- Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first dose of study drug administration, whichever is longer.

- Patients with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization visit. Nonmalignant lymphoproliferative disorders are also excluded.

- Patients with active tuberculosis or untreated latent tuberculosis infection.

- Pregnant or breast feeding women.

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: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Chile Investigational Site Number 152002 Santiago
Czech Republic Investigational Site Number 203034 Pardubice
Czech Republic Investigational Site Number 203001 Praha 2
Czech Republic Investigational Site Number 203002 Uherske Hradiste
Estonia Investigational Site Number 233002 Tallinn
Estonia Investigational Site Number 233010 Tallinn
Hungary Investigational Site Number 348014 Budapest
Hungary Investigational Site Number 348025 Budapest
Hungary Investigational Site Number 348021 Esztergom
Poland Investigational Site Number 616018 Poznan
Poland Investigational Site Number 616031 Warszawa
Poland Investigational Site Number 616012 Wroclaw
Russian Federation Investigational Site Number 643006 Kemerovo
Russian Federation Investigational Site Number 643001 Moscow
Russian Federation Investigational Site Number 643016 Ryazan
United States Investigational Site Number 840032 Amarillo Texas
United States Investigational Site Number 840124 Clarksburg West Virginia
United States Investigational Site Number 840009 Duncansville Pennsylvania
United States Investigational Site Number 840230 Elizabethtown Kentucky
United States Investigational Site Number 840231 Franklin Wisconsin
United States Investigational Site Number 840072 Gilbert Arizona
United States Investigational Site Number 840025 Jackson Tennessee
United States Investigational Site Number 840074 Mesquite Texas
United States Investigational Site Number 840233 Minot North Dakota
United States Investigational Site Number 840127 Oklahoma City Oklahoma
United States Investigational Site Number 840220 South Miami Florida
United States Investigational Site Number 840011 Tulsa Oklahoma
United States Investigational Site Number 840049 Upland California

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Chile,  Czech Republic,  Estonia,  Hungary,  Poland,  Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of anti-drug antibody (ADA) from baseline up to 24 weeks Yes
Secondary Safety as assessed by adverse events/serious adverse events, vital signs, physical examinations, clinical laboratory, ECGs from baseline up to 24 weeks Yes
Secondary Sarilumab exposure assessed by pre-dose serum sarilumab concentrations from baseline up to 24 weeks Yes
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