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

NCT ID: NCT02057250

Last Updated: 2017-06-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-03-31

Brief Summary

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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).

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Detailed Description

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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

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RA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sarilumab 150 mg by AID

Sarilumab 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.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Auto-Injector Device (AID)

Intervention Type DEVICE

Methotrexate

Intervention Type DRUG

Dispensed according to local practice.

Sulfasalazine

Intervention Type DRUG

Dispensed according to local practice.

Leflunomide

Intervention Type DRUG

Dispensed according to local practice.

Hydroxychloroquine

Intervention Type DRUG

Dispensed according to local practice.

Sarilumab 150 mg by PFS

Sarilumab 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.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Pre-filled Syringe (PFS)

Intervention Type DEVICE

Methotrexate

Intervention Type DRUG

Dispensed according to local practice.

Sulfasalazine

Intervention Type DRUG

Dispensed according to local practice.

Leflunomide

Intervention Type DRUG

Dispensed according to local practice.

Hydroxychloroquine

Intervention Type DRUG

Dispensed according to local practice.

Sarilumab 200 mg by AID

Sarilumab 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.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Auto-Injector Device (AID)

Intervention Type DEVICE

Methotrexate

Intervention Type DRUG

Dispensed according to local practice.

Sulfasalazine

Intervention Type DRUG

Dispensed according to local practice.

Leflunomide

Intervention Type DRUG

Dispensed according to local practice.

Hydroxychloroquine

Intervention Type DRUG

Dispensed according to local practice.

Sarilumab 200 mg by PFS

Sarilumab 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.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Pre-filled Syringe (PFS)

Intervention Type DEVICE

Methotrexate

Intervention Type DRUG

Dispensed according to local practice.

Sulfasalazine

Intervention Type DRUG

Dispensed according to local practice.

Leflunomide

Intervention Type DRUG

Dispensed according to local practice.

Hydroxychloroquine

Intervention Type DRUG

Dispensed according to local practice.

Interventions

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Sarilumab

Pharmaceutical form: Solution Route of administration: Subcutaneous

Intervention Type DRUG

Auto-Injector Device (AID)

Intervention Type DEVICE

Pre-filled Syringe (PFS)

Intervention Type DEVICE

Methotrexate

Dispensed according to local practice.

Intervention Type DRUG

Sulfasalazine

Dispensed according to local practice.

Intervention Type DRUG

Leflunomide

Dispensed according to local practice.

Intervention Type DRUG

Hydroxychloroquine

Dispensed according to local practice.

Intervention Type DRUG

Other Intervention Names

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SAR153191 REGN88

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840152

Huntsville, Alabama, United States

Site Status

Investigational Site Number 840221

Peoria, Arizona, United States

Site Status

Investigational Site Number 840226

Roseville, California, United States

Site Status

Investigational Site Number 840223

Boulder, Colorado, United States

Site Status

Investigational Site Number 840229

Miami, Florida, United States

Site Status

Investigational Site Number 840236

Orlando, Florida, United States

Site Status

Investigational Site Number 840155

Palm Harbor, Florida, United States

Site Status

Investigational Site Number 840220

South Miami, Florida, United States

Site Status

Investigational Site Number 840202

Hagerstown, Maryland, United States

Site Status

Investigational Site Number 840232

Flint, Michigan, United States

Site Status

Investigational Site Number 840233

Kalamazoo, Michigan, United States

Site Status

Investigational Site Number 840037

Tupelo, Mississippi, United States

Site Status

Investigational Site Number 840112

Lincoln, Nebraska, United States

Site Status

Investigational Site Number 840039

Albany, New York, United States

Site Status

Investigational Site Number 840224

Cincinnati, Ohio, United States

Site Status

Investigational Site Number 840002

Oklahoma City, Oklahoma, United States

Site Status

Investigational Site Number 840065

Tulsa, Oklahoma, United States

Site Status

Investigational Site Number 840009

Duncansville, Pennsylvania, United States

Site Status

Investigational Site Number 840062

Reading, Pennsylvania, United States

Site Status

Investigational Site Number 840016

North Charleston, South Carolina, United States

Site Status

Investigational Site Number 840025

Jackson, Tennessee, United States

Site Status

Investigational Site Number 840038

Austin, Texas, United States

Site Status

Investigational Site Number 840230

Carrollton, Texas, United States

Site Status

Investigational Site Number 840001

Dallas, Texas, United States

Site Status

Investigational Site Number 840020

Houston, Texas, United States

Site Status

Investigational Site Number 840239

Houston, Texas, United States

Site Status

Investigational Site Number 840241

Houston, Texas, United States

Site Status

Investigational Site Number 840242

Houston, Texas, United States

Site Status

Investigational Site Number 840069

Lubbock, Texas, United States

Site Status

Investigational Site Number 840074

Mesquite, Texas, United States

Site Status

Investigational Site Number 840237

Plano, Texas, United States

Site Status

Investigational Site Number 152005

Osorno, , Chile

Site Status

Investigational Site Number 152050

Santiago, , Chile

Site Status

Investigational Site Number 152014

Talca, , Chile

Site Status

Investigational Site Number 152007

Viña del Mar, , Chile

Site Status

Investigational Site Number 484002

Guadalajara, , Mexico

Site Status

Investigational Site Number 484004

Mérida, , Mexico

Site Status

Investigational Site Number 484005

Monterrey, , Mexico

Site Status

Investigational Site Number 616002

Bialystok, , Poland

Site Status

Investigational Site Number 616005

Lublin, , Poland

Site Status

Investigational Site Number 616004

Warsaw, , Poland

Site Status

Investigational Site Number 616017

Warsaw, , Poland

Site Status

Investigational Site Number 616012

Wroclaw, , Poland

Site Status

Investigational Site Number 643006

Kemerovo, , Russia

Site Status

Investigational Site Number 643020

Moscow, , Russia

Site Status

Investigational Site Number 643001

Moscow, , Russia

Site Status

Investigational Site Number 643008

Saint Petersburg, , Russia

Site Status

Investigational Site Number 710050

Bellville, , South Africa

Site Status

Investigational Site Number 710011

Cape Town, , South Africa

Site Status

Investigational Site Number 710007

Cape Town, , South Africa

Site Status

Investigational Site Number 710003

Durban, , South Africa

Site Status

Investigational Site Number 710001

Johannesburg, , South Africa

Site Status

Investigational Site Number 710051

Port Elizabeth, , South Africa

Site Status

Countries

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United States Chile Mexico Poland Russia South Africa

References

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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.

Reference Type DERIVED
PMID: 29209946 (View on PubMed)

Other Identifiers

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2012-004339-21

Identifier Type: -

Identifier Source: secondary_id

U1111-1130-9931

Identifier Type: OTHER

Identifier Source: secondary_id

MSC12665

Identifier Type: -

Identifier Source: org_study_id

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