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)

NCT ID: NCT02293902

Last Updated: 2018-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-10-31

Brief Summary

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.

Detailed 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).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sarilumab 150 mg/150 mg

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.

Group Type: EXPERIMENTAL

Sarilumab SAR153191 (REGN88)

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Methotrexate

Intervention Type: DRUG

Dispensed according to local practice.

Folic acid

Intervention Type: DRUG

Dispensed according to local practice.

Sarilumab 200 mg/200 mg

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.

Group Type: EXPERIMENTAL

Sarilumab SAR153191 (REGN88)

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Methotrexate

Intervention Type: DRUG

Dispensed according to local practice.

Folic acid

Intervention Type: DRUG

Dispensed according to local practice.

Placebo/Sarilumab 150 mg

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.

Group Type: PLACEBO_COMPARATOR

Sarilumab SAR153191 (REGN88)

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebo (for sarilumab)

Intervention Type: OTHER

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Methotrexate

Intervention Type: DRUG

Dispensed according to local practice.

Folic acid

Intervention Type: DRUG

Dispensed according to local practice.

Placebo/Sarilumab 200 mg

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.

Group Type: PLACEBO_COMPARATOR

Sarilumab SAR153191 (REGN88)

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebo (for sarilumab)

Intervention Type: OTHER

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Methotrexate

Intervention Type: DRUG

Dispensed according to local practice.

Folic acid

Intervention Type: DRUG

Dispensed according to local practice.

Interventions

Sarilumab SAR153191 (REGN88)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

Placebo (for sarilumab)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Intervention Type: OTHER

Methotrexate

Dispensed according to local practice.

Intervention Type: DRUG

Folic acid

Dispensed according to local practice.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392010

Asahi-Shi, , Japan

Investigational Site Number 392001

Asahikawa-Shi, , Japan

Investigational Site Number 392035

Asahikawa-Shi, , Japan

Investigational Site Number 392070

Beppu-Shi, , Japan

Investigational Site Number 392036

Chiba, , Japan

Investigational Site Number 392083

Chūōku, , Japan

Investigational Site Number 392047

Fuchu-Shi, , Japan

Investigational Site Number 392004

Fukui-shi, , Japan

Investigational Site Number 392007

Fukuoka, , Japan

Investigational Site Number 392038

Fukuoka, , Japan

Investigational Site Number 392039

Fukuoka, , Japan

Investigational Site Number 392078

Fukushima, , Japan

Investigational Site Number 392054

Funabashi-Shi, , Japan

Investigational Site Number 392015

Hachioji-Shi, , Japan

Investigational Site Number 392085

Hannan-Shi, , Japan

Investigational Site Number 392091

Hiroshima, , Japan

Investigational Site Number 392098

Hiroshima, , Japan

Investigational Site Number 392009

Hitachi-Naka, , Japan

Investigational Site Number 392011

Hitachi-Naka, , Japan

Investigational Site Number 392030

Ichinomiya-Shi, , Japan

Investigational Site Number 392002

Iizuka-Shi, , Japan

Investigational Site Number 392019

Kagoshima, , Japan

Investigational Site Number 392066

Kamakura-Shi, , Japan

Investigational Site Number 392086

Kamogawa-Shi, , Japan

Investigational Site Number 392050

Kato-Shi, , Japan

Investigational Site Number 392037

Kawachi-Nagano-Shi, , Japan

Investigational Site Number 392093

Kawagoe-Shi, , Japan

Investigational Site Number 392099

Kawasaki-Shi, , Japan

Investigational Site Number 392016

Kirishima-Shi, , Japan

Investigational Site Number 392013

Kitakyushu-Shi, , Japan

Investigational Site Number 392024

Kitakyushu-Shi, , Japan

Investigational Site Number 392045

Kitakyushu-Shi, , Japan

Investigational Site Number 392063

Kiyose-Shi, , Japan

Investigational Site Number 392051

Kobe, , Japan

Investigational Site Number 392097

Kochi, , Japan

Investigational Site Number 392040

Koushi-Shi, , Japan

Investigational Site Number 392069

Kumamoto, , Japan

Investigational Site Number 392089

Kurashiki-Shi, , Japan

Investigational Site Number 392065

Kushiro, , Japan

Investigational Site Number 392026

Matsuyama, , Japan

Investigational Site Number 392081

Matsuyama, , Japan

Investigational Site Number 392094

Matsuyama, , Japan

Investigational Site Number 392042

Meguro-Ku, , Japan

Investigational Site Number 392082

Meguro-Ku, , Japan

Investigational Site Number 392012

Mito, , Japan

Investigational Site Number 392034

Miyagi-Gun, , Japan

Investigational Site Number 392053

Morioka, , Japan

Investigational Site Number 392032

Nagano, , Japan

Investigational Site Number 392064

Nagasaki, , Japan

Investigational Site Number 392043

Nagoya, , Japan

Investigational Site Number 392056

Nagoya, , Japan

Investigational Site Number 392076

Nagoya, , Japan

Investigational Site Number 392080

Nagoya, , Japan

Investigational Site Number 392031

Nakano, , Japan

Investigational Site Number 392046

Narashino-Shi, , Japan

Investigational Site Number 392067

Narashino-Shi, , Japan

Investigational Site Number 392044

Nishinomiya-Shi, , Japan

Investigational Site Number 392062

Okayama, , Japan

Investigational Site Number 392008

Omura-Shi, , Japan

Investigational Site Number 392057

Osaka, , Japan

Investigational Site Number 392060

Osaka, , Japan

Investigational Site Number 392061

Osaka, , Japan

Investigational Site Number 392096

Osaka, , Japan

Investigational Site Number 392027

Osaki-Shi, , Japan

Investigational Site Number 392059

Ōita, , Japan

Investigational Site Number 392049

Sagamihara-Shi, , Japan

Investigational Site Number 392072

Saitama-Shi, , Japan

Investigational Site Number 392075

Sakaishi, , Japan

Investigational Site Number 392014

Sapporo, , Japan

Investigational Site Number 392068

Sapporo, , Japan

Investigational Site Number 392073

Sapporo, , Japan

Investigational Site Number 392006

Sasebo-Shi, , Japan

Investigational Site Number 392021

Sendai, , Japan

Investigational Site Number 392022

Sendai, , Japan

Investigational Site Number 392033

Sendai, , Japan

Investigational Site Number 392071

Sendai, , Japan

Investigational Site Number 392100

Sendai, , Japan

Investigational Site Number 392029

Shizuoka, , Japan

Investigational Site Number 392025

Sumida-Ku, , Japan

Investigational Site Number 392092

Sumida-Ku, , Japan

Investigational Site Number 392023

Takaoka-Shi, , Japan

Investigational Site Number 392095

Takarazuka-Shi, , Japan

Investigational Site Number 392020

Takasaki-Shi, , Japan

Investigational Site Number 392088

Takatsuki-Shi, , Japan

Investigational Site Number 392018

Tokorozawa-Shi, , Japan

Investigational Site Number 392003

Tomakomai-Shi, , Japan

Investigational Site Number 392005

Tomakomai-Shi, , Japan

Investigational Site Number 392077

Tonami-Shi, , Japan

Investigational Site Number 392052

Toshima-Ku, , Japan

Investigational Site Number 392058

Toyama, , Japan

Investigational Site Number 392055

Toyonaka-Shi, , Japan

Investigational Site Number 392074

Urasoe-Shi, , Japan

Investigational Site Number 392079

Urayasu-Shi, , Japan

Investigational Site Number 392048

Yokohama, , Japan

Investigational Site Number 392090

Yokohama, , Japan

Investigational Site Number 392101

Yokohama, , Japan

Countries

Japan

References

Tanaka Y, Takahashi T, Van Hoogstraten H, Praestgaard A, Kato N, Kameda H. Haemoglobin changes and disease activity in Japanese patients with rheumatoid arthritis treated with sarilumab. Clin Exp Rheumatol. 2023 May;41(5):1129-1139. doi: 10.55563/clinexprheumatol/jq9u8f. Epub 2022 Oct 28.

Reference Type: DERIVED

PMID: 36305354 (View on PubMed)

Tanaka Y, Wada K, Takahashi Y, Hagino O, van Hoogstraten H, Graham NMH, Kameda H. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan. Arthritis Res Ther. 2019 Mar 20;21(1):79. doi: 10.1186/s13075-019-1856-4.

Reference Type: DERIVED

PMID: 30894208 (View on PubMed)

Other Identifiers

U1111-1155-7401

Identifier Type: OTHER

Identifier Source: secondary_id

EFC14059

Identifier Type: -

Identifier Source: org_study_id