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RAPhase 3SARIL-RA-EASYNCT02057250

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

A Phase 3 study testing Sarilumab, Auto-Injector Device (AID) and Pre-filled Syringe (PFS) in people with RA, run by Sanofi at 53 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants. Secondary Objective: To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
RA
What is being tested?
Sarilumab, Auto-Injector Device (AID) and Pre-filled Syringe (PFS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
53 sitesin 6 countries
Study dates
Mar 2014to Mar 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of RA, ≥3 months disease duration;
  • Participant willing and able to self-inject;
  • Continuous treatment with 1 or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) (except leflunomide in combination with methotrexate);
  • Moderate-to-severely active RA.

Who cannot join

  • Participants <18 years;
  • Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists;
  • Treatment with tumor necrosis factor (TNF) antagonists;
  • Treatment with RA-directed biologic agents other than with a TNF-α antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent;
  • Prior treatment with a Janus kinase inhibitor.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

53 sites in 6 countries.

53 sites in 6 countries

United States31 sites

  • Investigational Site Number 840039

    Albany, New York, 12208

  • Investigational Site Number 840038

    Austin, Texas, 78705

  • Investigational Site Number 840223

    Boulder, Colorado, 80304

  • Investigational Site Number 840230

    Carrollton, Texas, 75007

  • Investigational Site Number 840224

    Cincinnati, Ohio, 45219

  • Investigational Site Number 840001

    Dallas, Texas, 75231

  • Investigational Site Number 840009

    Duncansville, Pennsylvania, 16635

  • Investigational Site Number 840232

    Flint, Michigan, 48504

  • Investigational Site Number 840202

    Hagerstown, Maryland, 21740

  • Investigational Site Number 840020

    Houston, Texas, 77034

  • Investigational Site Number 840239

    Houston, Texas, 77034

  • Investigational Site Number 840241

    Houston, Texas, 77034

  • Investigational Site Number 840242

    Houston, Texas, 77034

  • Investigational Site Number 840152

    Huntsville, Alabama, 35801

  • Investigational Site Number 840025

    Jackson, Tennessee, 38305

  • Investigational Site Number 840233

    Kalamazoo, Michigan, 49048

  • Investigational Site Number 840112

    Lincoln, Nebraska, 68516

  • Investigational Site Number 840069

    Lubbock, Texas, 79424

  • Investigational Site Number 840074

    Mesquite, Texas, 75150

  • Investigational Site Number 840229

    Miami, Florida, 33185

  • Investigational Site Number 840016

    North Charleston, South Carolina, 29406

  • Investigational Site Number 840002

    Oklahoma City, Oklahoma, 73103

  • Investigational Site Number 840236

    Orlando, Florida, 32804

  • Investigational Site Number 840155

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840221

    Peoria, Arizona, 85381

  • Investigational Site Number 840237

    Plano, Texas, 75042

  • Investigational Site Number 840062

    Reading, Pennsylvania, 19611

  • Investigational Site Number 840226

    Roseville, California, 95661

  • Investigational Site Number 840220

    South Miami, Florida, 33143

  • Investigational Site Number 840065

    Tulsa, Oklahoma, 74135

  • Investigational Site Number 840037

    Tupelo, Mississippi, 38801

Other trials in United States

South Africa6 sites

  • Investigational Site Number 710050

    Bellville, 7530

  • Investigational Site Number 710011

    Cape Town, 7405

  • Investigational Site Number 710007

    Cape Town, 7500

  • Investigational Site Number 710003

    Durban, 4001

  • Investigational Site Number 710001

    Johannesburg, 2013

  • Investigational Site Number 710051

    Port Elizabeth, 6045

Other trials in South Africa

Poland5 sites

  • Investigational Site Number 616002

    Bialystok, 15-351

  • Investigational Site Number 616005

    Lublin, 20-582

  • Investigational Site Number 616004

    Warsaw, 02-118

  • Investigational Site Number 616017

    Warsaw, 02-653

  • Investigational Site Number 616012

    Wroclaw, 50-044

Other trials in Poland

Chile4 sites

  • Investigational Site Number 152005

    Osorno, 5311092

  • Investigational Site Number 152050

    Santiago

  • Investigational Site Number 152014

    Talca

  • Investigational Site Number 152007

    Viña del Mar, 2520997

Other trials in Chile

Russia4 sites

  • Investigational Site Number 643006

    Kemerovo, 650000

  • Investigational Site Number 643020

    Moscow, 115404

  • Investigational Site Number 643001

    Moscow, 115522

  • Investigational Site Number 643008

    Saint Petersburg, 192242

Other trials in Russia

Mexico3 sites

  • Investigational Site Number 484002

    Guadalajara, 44690

  • Investigational Site Number 484004

    Mérida, 97000

  • Investigational Site Number 484005

    Monterrey, 64460

Other trials in Mexico

About this study

Official title: A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy

Primary Objective:

To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants.

Secondary Objective:

To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).

Read the detailed description

Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase of 12 weeks, extension phase of 52 weeks and post-treatment follow-up of 6 weeks.

For participants not entering the extension phase, total study duration up to 22 weeks (screening, AID assessment phase and follow-up).

Conditions
RA
Being tested
Sarilumab, Auto-Injector Device (AID), Pre-filled Syringe (PFS), Methotrexate, Sulfasalazine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SarilumabDrug

    Also called SAR153191, REGN88

    Pharmaceutical form: Solution Route of administration: Subcutaneous

  • Auto-Injector Device (AID)Device

  • Pre-filled Syringe (PFS)Device

  • MethotrexateDrug

    Dispensed according to local practice.

  • SulfasalazineDrug

    Dispensed according to local practice.

  • LeflunomideDrug

    Dispensed according to local practice.

  • HydroxychloroquineDrug

    Dispensed according to local practice.

Study groups in NCT02057250
Study groupRoleWhat they receive
Sarilumab 150 mg by AIDExperimentalSarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
Receives: Drug: Sarilumab; Device: Auto-Injector Device (AID); Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Hydroxychloroquine
Sarilumab 150 mg by PFSExperimentalSarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
Receives: Drug: Sarilumab; Device: Pre-filled Syringe (PFS); Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Hydroxychloroquine
Sarilumab 200 mg by AIDExperimentalSarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
Receives: Drug: Sarilumab; Device: Auto-Injector Device (AID); Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Hydroxychloroquine
Sarilumab 200 mg by PFSExperimentalSarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
Receives: Drug: Sarilumab; Device: Pre-filled Syringe (PFS); Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Hydroxychloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Validated AID Associated Product Technical Failures (PTFs)

    A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was "no" to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF.

    Measured: Baseline up to Week 12

Secondary outcomes (1)

  1. Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab

    AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).

    Measured: Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionFeb 2015
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057250
Sponsor's protocol ID
MSC12665
Other IDs
2012-004339-21, U1111-1130-9931
Acronym
SARIL-RA-EASY
Status last verified
May 2017
First submitted
31 Jan 2014
Last updated
20 Jun 2017
Data monitoring committee
Yes

Publications

  • Kivitz A, Baret-Cormel L, van Hoogstraten H, Wang S, Parrino J, Xu C, Stanislav M. Usability and Patient Preference Phase 3 Study of the Sarilumab Pen in Patients with Active Moderate-to-Severe Rheumatoid Arthritis. Rheumatol Ther. 2018 Jun;5(1):231-242. doi: 10.1007/s40744-017-0090-2. Epub 2017 Dec 5.

    PubMed 29209946

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sarilumab, Auto-Injector Device (AID) and Pre-filled Syringe (PFS) in people with RA, run by Sanofi at 53 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, South Africa, Poland, Chile, Russia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Validated AID Associated Product Technical Failures (PTFs) (time frame: Baseline up to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057250, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.

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