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

May 23, 2017 updated by: Sanofi

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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]).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 7501126
        • Investigational Site Number 152002
  • Czechia
      • Pardubice, Czechia, 53002
        • Investigational Site Number 203034
      • Praha 2, Czechia, 12850
        • Investigational Site Number 203001
      • Uherske Hradiste, Czechia, 686 01
        • Investigational Site Number 203002
  • Estonia
      • Tallinn, Estonia, 10138
        • Investigational Site Number 233010
      • Tallinn, Estonia, 13419
        • Investigational Site Number 233002
  • Hungary
      • Budapest, Hungary, 1027
        • Investigational Site Number 348014
      • Budapest, Hungary, 1027
        • Investigational Site Number 348025
      • Esztergom, Hungary, 2500
        • Investigational Site Number 348021
  • Poland
      • Poznan, Poland, 61-397
        • Investigational Site Number 616018
      • Warszawa, Poland, 01-518
        • Investigational Site Number 616031
      • Wroclaw, Poland, 50-044
        • Investigational Site Number 616012
  • Russian Federation
      • Kemerovo, Russian Federation, 650000
        • Investigational Site Number 643006
      • Moscow, Russian Federation, 115522
        • Investigational Site Number 643001
      • Ryazan, Russian Federation, 390026
        • Investigational Site Number 643016
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Investigational Site Number 840072
    • California
      • Upland, California, United States, 91786
        • Investigational Site Number 840049
    • Florida
      • South Miami, Florida, United States, 33143
        • Investigational Site Number 840220
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Investigational Site Number 840230
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Investigational Site Number 840233
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Investigational Site Number 840127
      • Tulsa, Oklahoma, United States, 74104
        • Investigational Site Number 840011
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Investigational Site Number 840009
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Investigational Site Number 840025
    • Texas
      • Amarillo, Texas, United States, 79124
        • Investigational Site Number 840032
      • Mesquite, Texas, United States, 75150
        • Investigational Site Number 840074
    • West Virginia
      • Clarksburg, West Virginia, United States, 26301
        • Investigational Site Number 840124
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Investigational Site Number 840231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • 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.
  • Participants with a history of malignancy other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization visit. Non-malignant lymphoproliferative disorders are also excluded.
  • Participants 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 Participant's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sarilumab 150 mg q2w
Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks.
Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Experimental: Sarilumab 200 mg q2w
Sarilumab 200 mg SC injection q2w for 24 weeks.
Drug: sarilumab SAR153191 (REGN88)
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
Time Frame: From Baseline to Week 30 [End of study (EOS)]
ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product [IMP] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.
From Baseline to Week 30 [End of study (EOS)]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Sarilumab Concentration
Time Frame: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30
Trough Concentration (Ctrough).
Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFC13752
  • 2013-002790-22
  • U1111-1143-4344 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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