To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

— SARIL-RA-ONE  

Official title:

An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis

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

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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