Rheumatoid Arthritis Clinical Trial
— SARIL-RA-ONEOfficial title:
An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis
Verified date | January 2016 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Sanofi | Regeneron Pharmaceuticals |
United States, Chile, Czech Republic, Estonia, Hungary, Poland, Russian Federation,
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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