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

Rheumatoid Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057250
• Other study ID #: MSC12665
• Secondary ID: 2012-004339-21U1
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2014
• Last updated: March 31, 2016
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To collect real-use data of the sarilumab auto-injector used by rheumatoid arthritis (RA) patients.

Secondary Objective:

To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).

Description:

Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase 12 weeks, extension phase 52 weeks, post-treatment follow-up of 6 weeks.

For patients not entering the extension phase, total study duration up to 22 weeks (screening, AID assessment phase and follow-up).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: March 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Diagnosis of rheumatoid arthritis (RA), =3 months disease duration

• Patient willing and able to self-inject

• Continuous treatment with 1 or a combination of nonbiologic DMARDs (except leflunomide in combination with methotrexate)

• Moderate-to-severely active RA

Exclusion criteria:

• Patients<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-a antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent

• Prior treatment with a Janus kinase inhibitor

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• sarilumab SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous

Device:
• Auto-injector (AID)

• Pre-filled Syringe (PFS)

Locations

Country	Name	City	State
Chile	Investigational Site Number 152005	Osorno
Chile	Investigational Site Number 152050	Santiago
Chile	Investigational Site Number 152014	Talca
Chile	Investigational Site Number 152007	Viña Del Mar
Mexico	Investigational Site Number 484002	Guadalajara
Mexico	Investigational Site Number 484004	Merida
Mexico	Investigational Site Number 484005	Monterrey
Poland	Investigational Site Number 616002	Bialystok
Poland	Investigational Site Number 616005	Lublin
Poland	Investigational Site Number 616004	Warszawa
Poland	Investigational Site Number 616017	Warszawa
Poland	Investigational Site Number 616012	Wroclaw
Russian Federation	Investigational Site Number 643006	Kemerovo
Russian Federation	Investigational Site Number 643001	Moscow
Russian Federation	Investigational Site Number 643020	Moscow
Russian Federation	Investigational Site Number 643008	Saint-Petersburg
South Africa	Investigational Site Number 710050	Bellville
South Africa	Investigational Site Number 710007	Cape Town
South Africa	Investigational Site Number 710011	Cape Town
South Africa	Investigational Site Number 710003	Durban
South Africa	Investigational Site Number 710001	Johannesburg
South Africa	Investigational Site Number 710051	Port Elizabeth
United States	Investigational Site Number 840039	Albany	New York
United States	Investigational Site Number 840038	Austin	Texas
United States	Investigational Site Number 840223	Boulder	Colorado
United States	Investigational Site Number 840230	Carrollton	Texas
United States	Investigational Site Number 840224	Cincinnati	Ohio
United States	Investigational Site Number 840001	Dallas	Texas
United States	Investigational Site Number 840009	Duncansville	Pennsylvania
United States	Investigational Site Number 840232	Flint	Michigan
United States	Investigational Site Number 840202	Hagerstown	Maryland
United States	Investigational Site Number 840020	Houston	Texas
United States	Investigational Site Number 840239	Houston	Texas
United States	Investigational Site Number 840241	Houston	Texas
United States	Investigational Site Number 840242	Houston	Texas
United States	Investigational Site Number 840152	Huntsville	Alabama
United States	Investigational Site Number 840025	Jackson	Tennessee
United States	Investigational Site Number 840233	Kalamazoo	Michigan
United States	Investigational Site Number 840112	Lincoln	Nebraska
United States	Investigational Site Number 840069	Lubbock	Texas
United States	Investigational Site Number 840074	Mesquite	Texas
United States	Investigational Site Number 840229	Miami	Florida
United States	Investigational Site Number 840016	North Charleston	South Carolina
United States	Investigational Site Number 840002	Oklahoma City	Oklahoma
United States	Investigational Site Number 840236	Orlando	Florida
United States	Investigational Site Number 840155	Palm Harbor	Florida
United States	Investigational Site Number 840221	Peoria	Arizona
United States	Investigational Site Number 840237	Plano	Texas
United States	Investigational Site Number 840062	Reading	Pennsylvania
United States	Investigational Site Number 840226	Roseville	California
United States	Investigational Site Number 840220	South Miami	Florida
United States	Investigational Site Number 840065	Tulsa	Oklahoma
United States	Investigational Site Number 840037	Tupelo	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Chile,  Mexico,  Poland,  Russian Federation,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of validated AID-associated product technical failures (PTFs)		Up to 12 weeks	No
Secondary	Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Sarilumab using the auto-injector (AID) versus the prefilled syringe (PFS)		Up to 12 weeks (during the AID assessment phase)	No