Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: Sarilumab; Drug: Golimumab; Drug: Folic/folinic acid; Drug: methotrexate (MTX)

• Registration Number: NCT01217814
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists.

Secondary Objectives:

* To assess the safety of sarilumab;

* To document the pharmacokinetic profile of sarilumab.

Detailed Description

The duration of the study period for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period.

Participants who completed the 12-week treatment period were offered enrollment in a separate long-term extension study (LTS11210/NCT01146652).

Study Timeline

• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Study Start: 2010-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Disposition First Submitted: 2012-10-31
• Disposition First Submitted QC: 2012-10-31
• Disposition First Posted: 2012-11-02
• Results First Submitted: 2017-05-23
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-31
• Last Update Submitted: 2017-07-31
• Results First Posted: 2017-09-01
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks.
Placebo	Folic/folinic acid	Placebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks.
Golimumab 50 mg	Placebo	Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks.
Golimumab 50 mg	methotrexate (MTX)	Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks.
Golimumab 50 mg	Folic/folinic acid	Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks.
Sarilumab 150 mg	Sarilumab	Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks.
Sarilumab 150 mg	Placebo	Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks.
Sarilumab 150 mg	methotrexate (MTX)	Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks.
Sarilumab 150 mg	Folic/folinic acid	Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks.
Placebo	methotrexate (MTX)	Placebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks.
Golimumab 50 mg	Golimumab	Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12	Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved at Least 50% Improvement in American College of Rheumatology (ACR50) Core Set Disease Activity Index at Week 12	Week 12
Percentage of Participants Who Achieved at Least 70% Improvement in American College of Rheumatology Core (ACR70) Set Disease Activity Index at Week 12	Week 12
Disease Activity Score for 28 Joints (DAS28) at Week 12	Week 12
European League Against Rheumatism (EULAR) Response at Week 12	Week 12
Percentage of Participants Achieving DAS28 Remission Score < 2.6 at Week 12	Week 12
Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab	Week 12

Trial Locations

Locations (14)

Investigational Site Number 484008; 🇲🇽 Durango, Mexico

Investigational Site Number 170004; 🇨🇴 Barranquilla, Colombia

Investigational Site Number 170005; 🇨🇴 Barranquilla, Colombia

Investigational Site Number 484002; 🇲🇽 Guadalajara, Mexico

Investigational Site Number 840026; 🇺🇸 Freehold, New Jersey, United States

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

Investigational Site Number 840043; 🇺🇸 New York, New York, United States

Investigational Site Number 380005; 🇮🇹 Genova, Italy

Investigational Site Number 724004; 🇪🇸 Oviedo, Spain

Investigational Site Number 380002; 🇮🇹 Firenze, Italy

Investigational Site Number 203002; 🇨🇿 Uherske Hradiste, Czechia

Investigational Site Number 724002; 🇪🇸 Valencia, Spain

Investigational Site Number 840038; 🇺🇸 Austin, Texas, United States

Investigational Site Number 170007; 🇨🇴 Bucaramanga, Colombia