To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: sarilumab SAR153191 (REGN88)

• Registration Number: NCT02121210
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To evaluate the immunogenicity of sarilumab administered as monotherapy.

Secondary Objectives:

* To evaluate the other safety aspects of sarilumab administered as monotherapy.

* To assess the exposure of sarilumab administered as monotherapy.

Detailed Description

Total study duration was up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 \[REGN88\]).

Study Timeline

• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-23
• Study Start: 2014-06
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Disposition First Submitted: 2016-01-06
• Disposition First Submitted QC: 2016-01-06
• Disposition First Posted: 2016-02-05
• Status Verified: 2017-05
• Results First Submitted: 2017-05-23
• Results First Submitted QC: 2017-05-23
• Last Update Submitted: 2017-05-23
• Results First Posted: 2017-06-20
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarilumab 150 mg q2w	sarilumab SAR153191 (REGN88)	Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks.
Sarilumab 200 mg q2w	sarilumab SAR153191 (REGN88)	Sarilumab 200 mg SC injection q2w for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)	From Baseline to Week 30 [End of study (EOS)]	ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product \[IMP\] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.

Secondary Outcome Measures

Name	Time	Method
Serum Sarilumab Concentration	Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30	Trough Concentration (Ctrough).

Trial Locations

Locations (28)

Investigational Site Number 643016; 🇷🇺 Ryazan, Russian Federation

Investigational Site Number 616031; 🇵🇱 Warszawa, Poland

Investigational Site Number 643006; 🇷🇺 Kemerovo, Russian Federation

Investigational Site Number 840220; 🇺🇸 South Miami, Florida, United States

Investigational Site Number 840230; 🇺🇸 Elizabethtown, Kentucky, United States

Investigational Site Number 840072; 🇺🇸 Gilbert, Arizona, United States

Investigational Site Number 840127; 🇺🇸 Oklahoma City, Oklahoma, United States

Investigational Site Number 233010; 🇪🇪 Tallinn, Estonia

Investigational Site Number 840231; 🇺🇸 Franklin, Wisconsin, United States

Investigational Site Number 840032; 🇺🇸 Amarillo, Texas, United States

Investigational Site Number 840011; 🇺🇸 Tulsa, Oklahoma, United States

Investigational Site Number 840025; 🇺🇸 Jackson, Tennessee, United States

Investigational Site Number 203002; 🇨🇿 Uherske Hradiste, Czechia

Investigational Site Number 203034; 🇨🇿 Pardubice, Czechia

Investigational Site Number 233002; 🇪🇪 Tallinn, Estonia

Investigational Site Number 348014; 🇭🇺 Budapest, Hungary

Investigational Site Number 348025; 🇭🇺 Budapest, Hungary

Investigational Site Number 348021; 🇭🇺 Esztergom, Hungary

Investigational Site Number 643001; 🇷🇺 Moscow, Russian Federation

Investigational Site Number 840049; 🇺🇸 Upland, California, United States

Investigational Site Number 203001; 🇨🇿 Praha 2, Czechia

Investigational Site Number 840124; 🇺🇸 Clarksburg, West Virginia, United States

Investigational Site Number 616018; 🇵🇱 Poznan, Poland

Investigational Site Number 616012; 🇵🇱 Wroclaw, Poland

Investigational Site Number 840233; 🇺🇸 Minot, North Dakota, United States

Investigational Site Number 840074; 🇺🇸 Mesquite, Texas, United States

Investigational Site Number 152002; 🇨🇱 Santiago, Chile

Investigational Site Number 840009; 🇺🇸 Duncansville, Pennsylvania, United States