An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

• Register: EUCTR
• Last refreshed on: 12 October 2015
• Main ID: EUCTR2012-001984-66-IT
• Date of registration: 07/05/2013
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis Recherche & Développement
• Public title: An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
• Scientific title: A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE
• Date of first enrolment: 02/07/2013
• Target sample size: 5910
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001984-66
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Argentina, Australia, Brazil, Chile, Colombia, Czech Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Norway, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Contact Point
• Affiliation: sanofi aventis SpA

• Name: Contact Point
• Affiliation: sanofi aventis SpA

Key inclusion & exclusion criteria

Inclusion criteria:
Diagnosis of rheumatoid arthritis (RA) >/= 3 months duration.
Continuous treatment of methotrexate (MTX) 10 - 25 mg/week (or per local labeling requirements if the dose range differs) for at least 12 weeks before screening visit and on a stable dose for 8 weeks before screening visit.
Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high sensitivity C-reactive protein > 10 mg/L.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2060
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 540

Exclusion criteria:
Age < 18 years.
Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of the screening visit.
Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks of the screening visit.
Prior treatment with a TNF (tumor necrosis factor)-alpha inhibitor, or other biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.
New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 inhibitors (COX-2 inhibitors within 4 weeks of the screening visit.
Treatment with traditional oral disease-modifying antirheumatic drugs (DMARD) /immunosuppressive agents other than MTX within 4 weeks or 12 weeks before the screening visit, depending on DMARD.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
CAS Number: 1189541-98-7
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 175-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Sarilumab
CAS Number: 1189541-98-7
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 131.6-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection/infusion in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 24

Primary end point(s): Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP score) score change from baseline (randomized treatment phase)

Main Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity Score for 28 joints (DAS28)

Secondary Objective: To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX)
To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX)
To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 24 for items 1 and 2
Week 12 for item 3

Secondary end point(s): - American Colleage of Rheumatology (ACR ) 20/50/70 response rate

- Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) remission score (<2.6) incidence rate

- Change from baseline in Disease Activity Score for 28 joints - C-reactive protein (DAS28-CRP) score

Secondary ID(s)

EFC11574

2012-001984-66-GB

Source(s) of Monetary Support

sanofi-aventis Recherche & Développement