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

Primary Purpose

RA

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sarilumab
Auto-Injector Device (AID)
Pre-filled Syringe (PFS)
Methotrexate
Sulfasalazine
Leflunomide
Hydroxychloroquine
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840152
  • Investigational Site Number 840221
  • Investigational Site Number 840226
  • Investigational Site Number 840223
  • Investigational Site Number 840229
  • Investigational Site Number 840236
  • Investigational Site Number 840155
  • Investigational Site Number 840220
  • Investigational Site Number 840202
  • Investigational Site Number 840232
  • Investigational Site Number 840233
  • Investigational Site Number 840037
  • Investigational Site Number 840112
  • Investigational Site Number 840039
  • Investigational Site Number 840224
  • Investigational Site Number 840002
  • Investigational Site Number 840065
  • Investigational Site Number 840009
  • Investigational Site Number 840062
  • Investigational Site Number 840016
  • Investigational Site Number 840025
  • Investigational Site Number 840038
  • Investigational Site Number 840230
  • Investigational Site Number 840001
  • Investigational Site Number 840020
  • Investigational Site Number 840239
  • Investigational Site Number 840241
  • Investigational Site Number 840242
  • Investigational Site Number 840069
  • Investigational Site Number 840074
  • Investigational Site Number 840237
  • Investigational Site Number 152005
  • Investigational Site Number 152050
  • Investigational Site Number 152014
  • Investigational Site Number 152007
  • Investigational Site Number 484002
  • Investigational Site Number 484004
  • Investigational Site Number 484005
  • Investigational Site Number 616002
  • Investigational Site Number 616005
  • Investigational Site Number 616004
  • Investigational Site Number 616017
  • Investigational Site Number 616012
  • Investigational Site Number 643006
  • Investigational Site Number 643020
  • Investigational Site Number 643001
  • Investigational Site Number 643008
  • Investigational Site Number 710050
  • Investigational Site Number 710011
  • Investigational Site Number 710007
  • Investigational Site Number 710003
  • Investigational Site Number 710001
  • Investigational Site Number 710051

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Sarilumab 150 mg by AID

Sarilumab 150 mg by PFS

Sarilumab 200 mg by AID

Sarilumab 200 mg by PFS

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
January 31, 2014
Last Updated
May 23, 2017
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02057250
Brief Title
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
Acronym
SARIL-RA-EASY
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sarilumab 150 mg by AID
Arm Type
Experimental
Arm Description
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.
Arm Title
Sarilumab 150 mg by PFS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sarilumab 200 mg by AID
Arm Type
Experimental
Arm Description
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.
Arm Title
Sarilumab 200 mg by PFS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sarilumab
Other Intervention Name(s)
SAR153191, REGN88
Intervention Description
Pharmaceutical form: Solution Route of administration: Subcutaneous
Intervention Type
Device
Intervention Name(s)
Auto-Injector Device (AID)
Intervention Type
Device
Intervention Name(s)
Pre-filled Syringe (PFS)
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Dispensed according to local practice.
Intervention Type
Drug
Intervention Name(s)
Sulfasalazine
Intervention Description
Dispensed according to local practice.
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Intervention Description
Dispensed according to local practice.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Dispensed according to local practice.
Primary Outcome Measure Information:
Title
Number of Validated AID Associated Product Technical Failures (PTFs)
Description
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.
Time Frame
Baseline up to Week 12
Secondary Outcome Measure Information:
Title
Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab
Description
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).
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840152
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Investigational Site Number 840221
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Investigational Site Number 840226
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Investigational Site Number 840223
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Investigational Site Number 840229
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Investigational Site Number 840236
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Investigational Site Number 840155
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Investigational Site Number 840220
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Investigational Site Number 840202
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Investigational Site Number 840232
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Investigational Site Number 840233
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Investigational Site Number 840037
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Investigational Site Number 840112
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Investigational Site Number 840039
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Investigational Site Number 840224
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Investigational Site Number 840002
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Investigational Site Number 840065
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Investigational Site Number 840009
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Investigational Site Number 840062
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Investigational Site Number 840016
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Investigational Site Number 840025
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Investigational Site Number 840038
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Investigational Site Number 840230
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Investigational Site Number 840001
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site Number 840020
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Investigational Site Number 840239
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Investigational Site Number 840241
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Investigational Site Number 840242
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Investigational Site Number 840069
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Investigational Site Number 840074
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Investigational Site Number 840237
City
Plano
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
Investigational Site Number 152005
City
Osorno
ZIP/Postal Code
5311092
Country
Chile
Facility Name
Investigational Site Number 152050
City
Santiago
Country
Chile
Facility Name
Investigational Site Number 152014
City
Talca
Country
Chile
Facility Name
Investigational Site Number 152007
City
Viña Del Mar
ZIP/Postal Code
2520997
Country
Chile
Facility Name
Investigational Site Number 484002
City
Guadalajara
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Investigational Site Number 484004
City
Merida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Investigational Site Number 484005
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number 616002
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Investigational Site Number 616005
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Investigational Site Number 616004
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Investigational Site Number 616017
City
Warszawa
ZIP/Postal Code
02-653
Country
Poland
Facility Name
Investigational Site Number 616012
City
Wroclaw
ZIP/Postal Code
50-044
Country
Poland
Facility Name
Investigational Site Number 643006
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Investigational Site Number 643020
City
Moscow
ZIP/Postal Code
115404
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Investigational Site Number 643008
City
Saint-Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Investigational Site Number 710050
City
Bellville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Investigational Site Number 710011
City
Cape Town
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Investigational Site Number 710007
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site Number 710003
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Investigational Site Number 710001
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Investigational Site Number 710051
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
29209946
Citation
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.
Results Reference
derived

Learn more about this trial

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

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