A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Sarilumab SAR153191 (REGN88); Drug: Folic acid; Other: Placebo (for sarilumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02293902

EFC14059

U1111-1155-7401 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

-To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX.

Secondary Objective:

-To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.

Full description

The total duration of study was expected up to 62 weeks (screening period of 4 weeks, treatment period of 52 weeks, and a 6-week post treatment observation).

Enrollment: 243 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with >=3 months disease duration.
• Moderately to severely active RA defined as:
• At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit.
• High sensitivity C-Reactive Protein (hs-CRP) >=6mg/L at screening visit.

Exclusion criteria

• Participants <20 or >75 years of age.
• Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to screening.
• Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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243 participants in 4 patient groups, including a placebo group

Sarilumab 150 mg/150 mg

Experimental group

Description:

Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits \[at least 4 weeks apart\] in either tender joint count \[TJC\] or swollen joint count \[SJC\], or with any other clear lack of efficacy based on investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.

Treatment:

Drug: Sarilumab SAR153191 (REGN88)

Drug: Folic acid

Drug: Methotrexate

Sarilumab 200 mg/200 mg

Experimental group

Description:

Sarilumab 200 mg SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by single-blind period in which participants continued with the same treatment up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits \[at least 4 weeks apart\] in either TJC or SJC, or with any other clear lack of efficacy based on investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.

Treatment:

Drug: Sarilumab SAR153191 (REGN88)

Drug: Folic acid

Drug: Methotrexate

Placebo/Sarilumab 150 mg

Placebo Comparator group

Description:

Placebo (for sarilumab) SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by a single-blind period in which participants were switched and received sarilumab 150 mg SC injection q2w in combination with MTX and folic acid up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits \[at least 4 weeks apart\] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.

Treatment:

Drug: Sarilumab SAR153191 (REGN88)

Drug: Folic acid

Other: Placebo (for sarilumab)

Drug: Methotrexate

Placebo/Sarilumab 200 mg

Placebo Comparator group

Description:

Placebo (for sarilumab) SC injection q2w in combination with MTX and folic acid in double-blind period up to Week 24 followed by a single-blind period in which participants were switched and received sarilumab 200 mg SC injection q2w in combination with MTX and folic acid up to Week 52. Participants with inadequate response (defined as less than 20% improvement from baseline on 2 consecutive visits \[at least 4 weeks apart\] in either TJC or SJC, or with any other clear lack of efficacy based on Investigator's judgment) by Week 16, were rescued with open label sarilumab 200 mg q2w treatment.

Treatment:

Drug: Sarilumab SAR153191 (REGN88)

Drug: Folic acid

Other: Placebo (for sarilumab)

Drug: Methotrexate