Clinical trial NCT02057250: To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: RA
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-02-07
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Validated AID Associated Product Technical Failures (PTFs)
timeFrame: Baseline up to Week 12
Secondary outcomes:
measure: Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab
timeFrame: 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
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Investigational Site Number 840152
state: Alabama
city: Peoria
country: United States
facility: Investigational Site Number 840221
state: Arizona
city: Roseville
country: United States
facility: Investigational Site Number 840226
state: California
city: Boulder
country: United States
facility: Investigational Site Number 840223
state: Colorado
city: Miami
country: United States
facility: Investigational Site Number 840229
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840236
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840155
state: Florida
city: South Miami
country: United States
facility: Investigational Site Number 840220
state: Florida
city: Hagerstown
country: United States
facility: Investigational Site Number 840202
state: Maryland
city: Flint
country: United States
facility: Investigational Site Number 840232
state: Michigan
city: Kalamazoo
country: United States
facility: Investigational Site Number 840233
state: Michigan
city: Tupelo
country: United States
facility: Investigational Site Number 840037
state: Mississippi
city: Lincoln
country: United States
facility: Investigational Site Number 840112
state: Nebraska
city: Albany
country: United States
facility: Investigational Site Number 840039
state: New York
city: Cincinnati
country: United States
facility: Investigational Site Number 840224
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site Number 840002
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site Number 840065
state: Oklahoma
city: Duncansville
country: United States
facility: Investigational Site Number 840009
state: Pennsylvania
city: Reading
country: United States
facility: Investigational Site Number 840062
state: Pennsylvania
city: North Charleston
country: United States
facility: Investigational Site Number 840016
state: South Carolina
city: Jackson
country: United States
facility: Investigational Site Number 840025
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840038
state: Texas
city: Carrollton
country: United States
facility: Investigational Site Number 840230
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840001
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840020
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840239
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840241
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840242
state: Texas
city: Lubbock
country: United States
facility: Investigational Site Number 840069
state: Texas
city: Mesquite
country: United States
facility: Investigational Site Number 840074
state: Texas
city: Plano
country: United States
facility: Investigational Site Number 840237
state: Texas
city: Osorno
country: Chile
facility: Investigational Site Number 152005
city: Santiago
country: Chile
facility: Investigational Site Number 152050
city: Talca
country: Chile
facility: Investigational Site Number 152014
city: Viña Del Mar
country: Chile
facility: Investigational Site Number 152007
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484002
city: Merida
country: Mexico
facility: Investigational Site Number 484004
city: Monterrey
country: Mexico
facility: Investigational Site Number 484005
city: Bialystok
country: Poland
facility: Investigational Site Number 616002
city: Lublin
country: Poland
facility: Investigational Site Number 616005
city: Warszawa
country: Poland
facility: Investigational Site Number 616004
city: Warszawa
country: Poland
facility: Investigational Site Number 616017
city: Wroclaw
country: Poland
facility: Investigational Site Number 616012
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 643006
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643020
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643001
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643008
city: Bellville
country: South Africa
facility: Investigational Site Number 710050
city: Cape Town
country: South Africa
facility: Investigational Site Number 710011
city: Cape Town
country: South Africa
facility: Investigational Site Number 710007
city: Durban
country: South Africa
facility: Investigational Site Number 710003
city: Johannesburg
country: South Africa
facility: Investigational Site Number 710001
city: Port Elizabeth
country: South Africa
facility: Investigational Site Number 710051
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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.