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To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) | Clinical Trials | Clareo Health

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

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

NCT02121210•Sanofi

View on ClinicalTrials.gov

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.

Detailed Description

Total study duration was 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, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 \[REGN88\]).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of rheumatoid arthritis (RA) ≥ 3 months.
•Moderately to severely active rheumatoid arthritis.
•Participants 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

•Participants \< 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 intra-articular 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.
+5 more criteria

Locations (28)

Investigational Site Number 840072

Gilbert, Arizona, United States

Investigational Site Number 840049

Upland, California, United States

Investigational Site Number 840220

South Miami, Florida, United States

Investigational Site Number 840230

Elizabethtown, Kentucky, United States

Investigational Site Number 840233

Minot, North Dakota, United States

Investigational Site Number 840127

Oklahoma City, Oklahoma, United States

Investigational Site Number 840011

Tulsa, Oklahoma, United States

Investigational Site Number 840009

Duncansville, Pennsylvania, United States

Investigational Site Number 840025

Jackson, Tennessee, United States

Investigational Site Number 840032

Amarillo, Texas, United States

Key Dates

Start Date

June 1, 2014

Primary Completion Date

May 1, 2015

Completion Date

May 1, 2015

Last Updated

June 20, 2017

Enrollment

132

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

sarilumab SAR153191 (REGN88)

DRUG

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITING

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

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Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

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