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Rheumatoid ArthritisPhase 1NCT02097524

Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)

A Phase 1 study testing Sarilumab and Tocilizumab in people with Rheumatoid Arthritis, run by Regeneron Pharmaceuticals at 19 sites in United States.

Completed

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

Official record
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Trial summary

The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab. 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 and Tocilizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
19 sitesUnited States
Study dates
Mar 2014to Apr 2015
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Patients with RA as defined by the 2010 revised American College of Rheumatology (ACR)
  • ACR Class I-III functional status, based on the 1991 revised criteria
  • Treated for a minimum of 12 weeks with Methotrexate with a stable dose of MTX for at least 8 weeks prior to screening visit

Who cannot join

  • Patients less than 18 years of age or minimum legal age
  • Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R) antagonists
  • 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 randomization
  • 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 is longer
  • Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other than MTX, within a certain amount of time prior to screening visit
Show all 10Show fewer
  • Active or suspected TB or at high risk of contracting TB
  • Fever, or chronic, persistent, or recurring infections requiring active treatment
  • HIV positive
  • Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Study site

    Austin, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Carrollton, Texas

  • Study site

    Channelview, Texas

  • Study site

    Charlotte, North Carolina

  • Study site

    Cinicinnati, Ohio

  • Study site

    Dallas, Texas

  • Study site

    DeLand, Florida

  • Study site

    Edgewater, Florida

  • Study site

    Grand Blanc, Michigan

  • Study site

    Granger, Indiana

  • Study site

    Houston, Texas

  • Study site

    Memphis, Tennessee

  • Study site

    Mesquite, Texas

  • Study site

    Miami, Florida

  • Study site

    Miami Lakes, Florida

  • Study site

    Orange, California

  • Study site

    Plano, Texas

  • Study site

    San Antonio, Texas

Other trials in United States

About this study

The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.

Being tested
Sarilumab, Tocilizumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • SarilumabDrug

    Also called REGN88, SAR153191

  • TocilizumabDrug

Study groups in NCT02097524
Study groupRoleWhat they receive
Sarilumab - dose 1ExperimentalSingle subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Receives: Drug: Sarilumab
Sarilumab - dose 2ExperimentalSingle SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Receives: Drug: Sarilumab
Tocilizumab - dose 1Active comparatorSingle intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Receives: Drug: Tocilizumab
Tocilizumab - dose 2Active comparatorSingle IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Receives: Drug: Tocilizumab

What is being measured

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

  1. PD parameters

    Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4:

    • the time to nadir (or peak)
    • change from baseline
    • area under the curve (AUC)

    Measured: baseline through week 4

Secondary outcomes (2)

  1. Percentage of TEAEs

    Percentage of patients with treatment-emergent adverse events (TEAEs) from baseline through end of study (week 6).

    Measured: baseline through week 6

  2. PK parameters

    Pharmacokinetic (PK) parameters, what the body does to a drug, will be collected from baseline through week 4:

    • AUC
    • CL (clearance)
    • Cmax (the peak concentration)
    • t1/2 (observed terminal half-life)

    Measured: baseline through week 4

Timeline

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

  1. First posted27 Mar 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02097524
Sponsor's protocol ID
6R88-RA-1309
Status last verified
May 2015
First submitted
3 Mar 2014
Last updated
5 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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 1 study testing Sarilumab and Tocilizumab in people with Rheumatoid Arthritis, run by Regeneron Pharmaceuticals at 19 sites in United States.

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 3 inclusion and 10 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 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

PD parameters (time frame: baseline through week 4). 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 NCT02097524, which also lists 2 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 5 May 2015.

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