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AzTrials

Rheumatoid ArthritisPhase 3NCT01768572

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

A Phase 3 study testing sarilumab SAR153191 (REGN88), tocilizumab and hydroxychloroquine in people with Rheumatoid Arthritis, run by Sanofi at 78 sites in 19 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 assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
sarilumab SAR153191 (REGN88), tocilizumab and hydroxychloroquine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
78 sitesin 19 countries
Study dates
Mar 2013to Oct 2014
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 was, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria with ≥ 3 months disease duration
  • ACR Class I-III functional status, was based on the 1991 revised criteria. Moderate-to-severely active RA. Anti-TNF therapy failures, was defined as participants with an inadequate clinical response was defined by the investigator, after being treated for at least 3 consecutive months, and/or intolerance to at least 1 TNF-antagonist, resulting in or requiring their discontinuation. TNF-antagonists were include, but were not limited to, etanercept, infliximab, adalimumab, golimumab and/or certolizumab pegol
  • Continuous treatment with one or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) for at least 12 consecutive weeks prior to screening and on a stable dose(s) for at least 6 consecutive weeks prior to screening:
  • Methotrexate - 10 to 25 milligram/week orally or parenteral (or per local labelling requirements if the dose range differs)
  • Leflunomide - 10 to 20 mg orally daily
  • Sulfasalazine (SSZ) - 1000 to 3000 mg orally daily
  • Hydroxychloroquine (HCQ) - 200 to 400 mg orally daily

Who cannot join

  • Participants <18 years of age. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
  • Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to screening
  • 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 systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome
  • Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the Screening Visit, whichever was longer
  • Participants with active tuberculosis or latent tuberculosis infection. Prior or current history of interstitial lung disease. Prior treatment with anti-interleukin (IL) -6 or anti-IL-6R therapies, including but not limited to tocilizumab or sarilumab
Show all 16Show fewer
  • Treatment with anti-TNF agents, as follows:
  • Etanercept: within 28 days prior to randomization
  • Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization
  • Treatment with RA-directed biologic agents with non- TNF-α antagonist mechanisms without adequate washout as follows:
  • Anakinra: within 28 days prior to randomization
  • Abatacept: within 42 days prior to randomization
  • Rituximab or other cell depleting agent: Within 6 months prior to randomization or until total lymphocyte count and CD 19+ lymphocyte count were normalized, or whichever was longer
  • Prior treatment with a janus kinase (JAK) inhibitor (eg, tofacitinib). Participants with a history of invasive opportunistic infection. Prior or current history of malignancy, including lymphoproliferative diseases, 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 (baseline) visit
  • Prior or current history of other significant concomitant illness(es) that, according to Investigator's judgement, was adversely affect the participant's participation in the study.
  • 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

78 sites in 19 countries.

78 sites in 19 countries

United States14 sites

  • Investigational Site Number 840038

    Austin, Texas, 78705

  • Investigational Site Number 840153

    Aventura, Florida, 33180

  • Investigational Site Number 840154

    Boston, Massachusetts, 02115

  • Investigational Site Number 840151

    Colorado Springs, Colorado, 80903

  • Investigational Site Number 840022

    Dallas, Texas, 75235

  • Investigational Site Number 840156

    Dallas, Texas, 75246

  • Investigational Site Number 840033

    Fort Lauderdale, Florida, 33334

  • Investigational Site Number 840152

    Huntsville, Alabama, 35801

  • Investigational Site Number 840150

    Lansing, Michigan, 48910

  • Investigational Site Number 840074

    Mesquite, Texas, 75150

  • Investigational Site Number 840048

    Miami, Florida, 33155

  • Investigational Site Number 840155

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840062

    Reading, Pennsylvania, 19611

  • Investigational Site Number 840013

    Wheaton, Maryland, 20902

Other trials in United States

Russia7 sites

  • Investigational Site Number 643017

    Kemerovo, 650066

  • Investigational Site Number 643020

    Moscow, 115404

  • Investigational Site Number 643001

    Moscow, 115522

  • Investigational Site Number 643002

    Moscow, 117997

  • Investigational Site Number 643031

    Moscow, 121374

  • Investigational Site Number 643030

    Moscow, 125284

  • Investigational Site Number 643032

    Saint Petersburg, 191186

Other trials in Russia

Argentina6 sites

  • Investigational Site Number 032006

    Caba, C1015ABO

  • Investigational Site Number 032010

    Ramos Mejía, B1704ETD

  • Investigational Site Number 032013

    Rosario, S200PBJ

  • Investigational Site Number 032015

    San Fernando

  • Investigational Site Number 032004

    San Miguel de Tucumán, 4000

  • Investigational Site Number 032005

    San Miguel de Tucumán, 4000

Other trials in Argentina

Hungary6 sites

  • Investigational Site Number 348014

    Budapest, 1027

  • Investigational Site Number 348022

    Budapest, 1036

  • Investigational Site Number 348021

    Esztergom, 2500

  • Investigational Site Number 348016

    Kistarcsa, 2143

  • Investigational Site Number 348009

    Szolnok, 5000

  • Investigational Site Number 348015

    Szombathely, 9700

Other trials in Hungary

Romania6 sites

  • Investigational Site Number 642006

    Brăila, 810019

  • Investigational Site Number 642021

    Bucharest, 010584

  • Investigational Site Number 642001

    Bucharest, 010976

  • Investigational Site Number 642020

    Bucharest, 020125

  • Investigational Site Number 642010

    Bucharest

  • Investigational Site Number 642022

    Targoviste, 130083

Other trials in Romania

United Kingdom6 sites

  • Investigational Site Number 826004

    Doncaster, DN2 5LT

  • Investigational Site Number 826006

    Edinburgh, EH4 2XU

  • Investigational Site Number 826001

    Leeds, LS7 4SA

  • Investigational Site Number 826002

    London, E11 1NR

  • Investigational Site Number 826005

    Southampton, SO16 6YD

  • Investigational Site Number 826025

    Wigan, WN6 9EP

Other trials in United Kingdom

Mexico5 sites

  • Investigational Site Number 484008

    Durango, 34080

  • Investigational Site Number 484035

    León, 37000

  • Investigational Site Number 484009

    Mérida, 97000

  • Investigational Site Number 484001

    México, D.F., 11850

  • Investigational Site Number 484036

    Zapopan, 44280

Other trials in Mexico

Poland5 sites

  • Investigational Site Number 616019

    Bydgoszcz, 85-168

  • Investigational Site Number 616054

    Bytom, 41-902

  • Investigational Site Number 616030

    Lublin, 20-090

  • Investigational Site Number 616031

    Warsaw, 01-518

  • Investigational Site Number 616017

    Warsaw, 02-653

Other trials in Poland

Czechia3 sites

  • Investigational Site Number 203009

    Liberec, 46063

  • Investigational Site Number 203011

    Prague, 12850

  • Investigational Site Number 203010

    Prague, 140 00

Other trials in Czechia

Spain3 sites

  • Investigational Site Number 724020

    Barcelona, 08035

  • Investigational Site Number 724021

    Santander, 39008

  • Investigational Site Number 724022

    Seville, 41010

Other trials in Spain

Brazil2 sites

  • Investigational Site Number 076001

    Curitiba, 80060-240

  • Investigational Site Number 076030

    São José do Rio Preto, 15090-000

Other trials in Brazil

Estonia2 sites

  • Investigational Site Number 233010

    Tallinn, 10138

  • Investigational Site Number 233002

    Tallinn, 13419

Other trials in Estonia

Finland2 sites

  • Investigational Site Number 246001

    Helsinki, 00290

  • Investigational Site Number 246010

    Riihimäki, 11120

Other trials in Finland

Israel2 sites

  • Investigational Site Number 376010

    Haifa, 31096

  • Investigational Site Number 376011

    Tel Aviv, 64239

Other trials in Israel

Italy2 sites

  • Investigational Site Number 380002

    Florence, 50141

  • Investigational Site Number 380005

    Genova, 16132

Other trials in Italy

Netherlands2 sites

  • Investigational Site Number 528010

    Amsterdam, 1056 AB

  • Investigational Site Number 528001

    Leiden, 2333 ZA

Other trials in Netherlands

Norway2 sites

  • Investigational Site Number 578010

    Kristiansand, 4604

  • Investigational Site Number 578006

    Tønsberg, 3105

Other trials in Norway

Sweden2 sites

  • Investigational Site Number 752004

    Malmö, 205 02

  • Investigational Site Number 752002

    Uppsala, 751 85

Other trials in Sweden

Belgium1 site

  • Investigational Site Number 056010

    Leuven, 3000

Other trials in Belgium

About this study

Official title: A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists

Primary Objective:

To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

Read the detailed description

Total study duration was up to 34 weeks: Screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks.

After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).

Being tested
sarilumab SAR153191 (REGN88), tocilizumab, hydroxychloroquine, methotrexate, sulfasalazine
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • sarilumab SAR153191 (REGN88)Drug

    Pharmaceutical form: solution Route of administration: subcutaneous

  • tocilizumabDrug

    Pharmaceutical form: solution Route of administration: intravenous

  • hydroxychloroquineDrug

    Dispensed according to local practice.

  • methotrexateDrug

    Dispensed according to local practice.

  • sulfasalazineDrug

    Dispensed according to local practice.

  • leflunomideDrug

    Dispensed according to local practice.

  • subcutaneous placeboDrug

    Pharmaceutical form: solution Route of administration: subcutaneous

  • intravenous placeboDrug

    Pharmaceutical form: solution Route of administration: intravenous

Study groups in NCT01768572
Study groupRoleWhat they receive
Sarilumab 150 mg q2wExperimentalSarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
Receives: Drug: sarilumab SAR153191 (REGN88); Drug: hydroxychloroquine; Drug: methotrexate; Drug: sulfasalazine; Drug: leflunomide; Drug: intravenous placebo
Sarilumab 200 mg q2wExperimentalSarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
Receives: Drug: sarilumab SAR153191 (REGN88); Drug: hydroxychloroquine; Drug: methotrexate; Drug: sulfasalazine; Drug: leflunomide; Drug: intravenous placebo
Tocilizumab q4wActive comparatorTocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
Receives: Drug: tocilizumab; Drug: hydroxychloroquine; Drug: methotrexate; Drug: sulfasalazine; Drug: leflunomide; Drug: subcutaneous placebo

What is being measured

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

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.

    Measured: Up to 211 days

Timeline

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

  1. First posted15 Jan 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionOct 2014
  4. Study completionOct 2014

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01768572
Sponsor's protocol ID
SFY13370
Other IDs
2012-003536-23, U1111-1133-7839
Status last verified
Jun 2017
First submitted
11 Jan 2013
Last updated
26 Jun 2017
Data monitoring committee
Yes

Publications

  • Rehberg M, Giegerich C, Praestgaard A, van Hoogstraten H, Iglesias-Rodriguez M, Curtis JR, Gottenberg JE, Schwarting A, Castaneda S, Rubbert-Roth A, Choy EHS; MOBILITY, MONARCH, TARGET, and ASCERTAIN investigators. Identification of a Rule to Predict Response to Sarilumab in Patients with Rheumatoid Arthritis Using Machine Learning and Clinical Trial Data. Rheumatol Ther. 2021 Dec;8(4):1661-1675. doi: 10.1007/s40744-021-00361-5. Epub 2021 Sep 14.

    PubMed 34519964

  • Kovalenko P, Paccaly A, Boyapati A, Xu C, St John G, Nivens MC, Davis JD, Rippley R, DiCioccio AT. Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis. CPT Pharmacometrics Syst Pharmacol. 2020 Jul;9(7):405-416. doi: 10.1002/psp4.12534. Epub 2020 Jun 20.

    PubMed 32453485

  • Emery P, Rondon J, Parrino J, Lin Y, Pena-Rossi C, van Hoogstraten H, Graham NMH, Liu N, Paccaly A, Wu R, Spindler A. Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis. Rheumatology (Oxford). 2019 May 1;58(5):849-858. doi: 10.1093/rheumatology/key361.

    PubMed 30590833

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sarilumab SAR153191 (REGN88), tocilizumab and hydroxychloroquine in people with Rheumatoid Arthritis, run by Sanofi at 78 sites in 19 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 7 inclusion and 16 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 26 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 78 sites in United States, Russia, Argentina, Hungary, Romania and 14 more countries. 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 26 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 Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 211 days). 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 NCT01768572, which also lists 3 linked publications.

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 26 Jun 2017.

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