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

NCT02057250 | Completed Phase 3 Results DMC

• 3 other identifiers: MSC126652012-004339-21U1111-1130-9931
• Study Type: interventional
• Target: 217
• Locations: 6 countries
• Sites: 53

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).

Conditions

RA

Outcome Measures

Primary Outcomes (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.

  Baseline up to Week 12

Secondary Outcomes (1)

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

  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

Study Arms (4)

Sarilumab 150 mg by AID

EXPERIMENTAL

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.

Drug: Sarilumab; Device: Auto-Injector Device (AID); Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Hydroxychloroquine

Sarilumab 150 mg by PFS

EXPERIMENTAL

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.

Drug: Sarilumab; Device: Pre-filled Syringe (PFS); Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Hydroxychloroquine

Sarilumab 200 mg by AID

EXPERIMENTAL

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.

Drug: Sarilumab; Device: Auto-Injector Device (AID); Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Hydroxychloroquine

Sarilumab 200 mg by PFS

EXPERIMENTAL

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.

Drug: Sarilumab; Device: Pre-filled Syringe (PFS); Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Hydroxychloroquine

Interventions

Sarilumab DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Also known as: SAR153191, REGN88

Sarilumab 150 mg by AID; Sarilumab 150 mg by PFS; Sarilumab 200 mg by AID; Sarilumab 200 mg by PFS

Auto-Injector Device (AID) DEVICE

Sarilumab 150 mg by AID; Sarilumab 200 mg by AID

Pre-filled Syringe (PFS) DEVICE

Sarilumab 150 mg by PFS; Sarilumab 200 mg by PFS

Methotrexate DRUG

Dispensed according to local practice.

Sarilumab 150 mg by AID; Sarilumab 150 mg by PFS; Sarilumab 200 mg by AID; Sarilumab 200 mg by PFS

Sulfasalazine DRUG

Dispensed according to local practice.

Sarilumab 150 mg by AID; Sarilumab 150 mg by PFS; Sarilumab 200 mg by AID; Sarilumab 200 mg by PFS

Leflunomide DRUG

Dispensed according to local practice.

Sarilumab 150 mg by AID; Sarilumab 150 mg by PFS; Sarilumab 200 mg by AID; Sarilumab 200 mg by PFS

Hydroxychloroquine DRUG

Dispensed according to local practice.

Sarilumab 150 mg by AID; Sarilumab 150 mg by PFS; Sarilumab 200 mg by AID; Sarilumab 200 mg by PFS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (53)

Investigational Site Number 840152

Huntsville, Alabama, 35801, United States

Location

Investigational Site Number 840221

Peoria, Arizona, 85381, United States

Location

Investigational Site Number 840226

Roseville, California, 95661, United States

Location

Investigational Site Number 840223

Boulder, Colorado, 80304, United States

Location

Investigational Site Number 840229

Miami, Florida, 33185, United States

Location

Investigational Site Number 840236

Orlando, Florida, 32804, United States

Location

Investigational Site Number 840155

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840220

South Miami, Florida, 33143, United States

Location

Investigational Site Number 840202

Hagerstown, Maryland, 21740, United States

Location

Investigational Site Number 840232

Flint, Michigan, 48504, United States

Location

Investigational Site Number 840233

Kalamazoo, Michigan, 49048, United States

Location

Investigational Site Number 840037

Tupelo, Mississippi, 38801, United States

Location

Investigational Site Number 840112

Lincoln, Nebraska, 68516, United States

Location

Investigational Site Number 840039

Albany, New York, 12208, United States

Location

Investigational Site Number 840224

Cincinnati, Ohio, 45219, United States

Location

Investigational Site Number 840002

Oklahoma City, Oklahoma, 73103, United States

Location

Investigational Site Number 840065

Tulsa, Oklahoma, 74135, United States

Location

Investigational Site Number 840009

Duncansville, Pennsylvania, 16635, United States

Location

Investigational Site Number 840062

Reading, Pennsylvania, 19611, United States

Location

Investigational Site Number 840016

North Charleston, South Carolina, 29406, United States

Location

Investigational Site Number 840025

Jackson, Tennessee, 38305, United States

Location

Investigational Site Number 840038

Austin, Texas, 78705, United States

Location

Investigational Site Number 840230

Carrollton, Texas, 75007, United States

Location

Investigational Site Number 840001

Dallas, Texas, 75231, United States

Location

Investigational Site Number 840020

Houston, Texas, 77034, United States

Location

Investigational Site Number 840239

Houston, Texas, 77034, United States

Location

Investigational Site Number 840241

Houston, Texas, 77034, United States

Location

Investigational Site Number 840242

Houston, Texas, 77034, United States

Location

Investigational Site Number 840069

Lubbock, Texas, 79424, United States

Location

Investigational Site Number 840074

Mesquite, Texas, 75150, United States

Location

Investigational Site Number 840237

Plano, Texas, 75042, United States

Location

Investigational Site Number 152005

Osorno, 5311092, Chile

Location

Investigational Site Number 152050

Santiago, Chile

Location

Investigational Site Number 152014

Talca, Chile

Location

Investigational Site Number 152007

Viña del Mar, 2520997, Chile

Location

Investigational Site Number 484002

Guadalajara, 44690, Mexico

Location

Investigational Site Number 484004

Mérida, 97000, Mexico

Location

Investigational Site Number 484005

Monterrey, 64460, Mexico

Location

Investigational Site Number 616002

Bialystok, 15-351, Poland

Location

Investigational Site Number 616005

Lublin, 20-582, Poland

Location

Investigational Site Number 616004

Warsaw, 02-118, Poland

Location

Investigational Site Number 616017

Warsaw, 02-653, Poland

Location

Investigational Site Number 616012

Wroclaw, 50-044, Poland

Location

Investigational Site Number 643006

Kemerovo, 650000, Russia

Location

Investigational Site Number 643020

Moscow, 115404, Russia

Location

Investigational Site Number 643001

Moscow, 115522, Russia

Location

Investigational Site Number 643008

Saint Petersburg, 192242, Russia

Location

Investigational Site Number 710050

Bellville, 7530, South Africa

Location

Investigational Site Number 710011

Cape Town, 7405, South Africa

Location

Investigational Site Number 710007

Cape Town, 7500, South Africa

Location

Investigational Site Number 710003

Durban, 4001, South Africa

Location

Investigational Site Number 710001

Johannesburg, 2013, South Africa

Location

Investigational Site Number 710051

Port Elizabeth, 6045, South Africa

Location

Related Publications (1)

• 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.

  PMID: 29209946 DERIVED

MeSH Terms

Interventions

sarilumab; Methotrexate; Sulfasalazine; Leflunomide; Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Chloroquine; Aminoquinolines; Quinolines

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 7, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2016
• Last Updated: June 20, 2017
• Results First Posted: June 20, 2017

Record last verified: 2017-05

Locations

US (31); CL (4); ZA (6); PL (5); RU (4); ME (3)