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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

132

Phase

  • 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

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
Intervention / Treatment
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

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

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

Sanofi

Collaborators

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

June 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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