Clinical trial NCT02293902: 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)
Official title: A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-11-19
Enrollment: 243
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
measure: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
timeFrame: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
timeFrame: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
timeFrame: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
timeFrame: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
timeFrame: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
timeFrame: For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm : Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58
Other outcomes:
Locations:
city: Asahi-Shi
country: Japan
facility: Investigational Site Number 392010
city: Asahikawa-Shi
country: Japan
facility: Investigational Site Number 392001
city: Asahikawa-Shi
country: Japan
facility: Investigational Site Number 392035
city: Beppu-Shi
country: Japan
facility: Investigational Site Number 392070
city: Chiba-Shi
country: Japan
facility: Investigational Site Number 392036
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392083
city: Fuchu-Shi
country: Japan
facility: Investigational Site Number 392047
city: Fukui-Shi
country: Japan
facility: Investigational Site Number 392004
city: Fukuoka-Shi
country: Japan
facility: Investigational Site Number 392007
city: Fukuoka-Shi
country: Japan
facility: Investigational Site Number 392038
city: Fukuoka-Shi
country: Japan
facility: Investigational Site Number 392039
city: Fukushima-Shi
country: Japan
facility: Investigational Site Number 392078
city: Funabashi-Shi
country: Japan
facility: Investigational Site Number 392054
city: Hachioji-Shi
country: Japan
facility: Investigational Site Number 392015
city: Hannan-Shi
country: Japan
facility: Investigational Site Number 392085
city: Hiroshima-Shi
country: Japan
facility: Investigational Site Number 392091
city: Hiroshima-Shi
country: Japan
facility: Investigational Site Number 392098
city: Hitachinaka-Shi
country: Japan
facility: Investigational Site Number 392009
city: Hitachinaka-Shi
country: Japan
facility: Investigational Site Number 392011
city: Ichinomiya-Shi
country: Japan
facility: Investigational Site Number 392030
city: Iizuka-Shi
country: Japan
facility: Investigational Site Number 392002
city: Kagoshima-Shi
country: Japan
facility: Investigational Site Number 392019
city: Kamakura-Shi
country: Japan
facility: Investigational Site Number 392066
city: Kamogawa-Shi
country: Japan
facility: Investigational Site Number 392086
city: Kato-Shi
country: Japan
facility: Investigational Site Number 392050
city: Kawachi-Nagano-Shi
country: Japan
facility: Investigational Site Number 392037
city: Kawagoe-Shi
country: Japan
facility: Investigational Site Number 392093
city: Kawasaki-Shi
country: Japan
facility: Investigational Site Number 392099
city: Kirishima-Shi
country: Japan
facility: Investigational Site Number 392016
city: Kitakyushu-Shi
country: Japan
facility: Investigational Site Number 392013
city: Kitakyushu-Shi
country: Japan
facility: Investigational Site Number 392024
city: Kitakyushu-Shi
country: Japan
facility: Investigational Site Number 392045
city: Kiyose-Shi
country: Japan
facility: Investigational Site Number 392063
city: Kobe-Shi
country: Japan
facility: Investigational Site Number 392051
city: Kochi-Shi
country: Japan
facility: Investigational Site Number 392097
city: Koushi-Shi
country: Japan
facility: Investigational Site Number 392040
city: Kumamoto-Shi
country: Japan
facility: Investigational Site Number 392069
city: Kurashiki-Shi
country: Japan
facility: Investigational Site Number 392089
city: Kushiro-Shi
country: Japan
facility: Investigational Site Number 392065
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392026
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392081
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392094
city: Meguro-Ku
country: Japan
facility: Investigational Site Number 392042
city: Meguro-Ku
country: Japan
facility: Investigational Site Number 392082
city: Mito-Shi
country: Japan
facility: Investigational Site Number 392012
city: Miyagi-Gun
country: Japan
facility: Investigational Site Number 392034
city: Morioka-Shi
country: Japan
facility: Investigational Site Number 392053
city: Nagano-Shi
country: Japan
facility: Investigational Site Number 392032
city: Nagasaki-Shi
country: Japan
facility: Investigational Site Number 392064
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392043
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392056
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392076
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392080
city: Nakano-Ku
country: Japan
facility: Investigational Site Number 392031
city: Narashino-Shi
country: Japan
facility: Investigational Site Number 392046
city: Narashino-Shi
country: Japan
facility: Investigational Site Number 392067
city: Nishinomiya-Shi
country: Japan
facility: Investigational Site Number 392044
city: Oita-Shi
country: Japan
facility: Investigational Site Number 392059
city: Okayama-Shi
country: Japan
facility: Investigational Site Number 392062
city: Omura-Shi
country: Japan
facility: Investigational Site Number 392008
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392057
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392060
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392061
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392096
city: Osaki-Shi
country: Japan
facility: Investigational Site Number 392027
city: Sagamihara-Shi
country: Japan
facility: Investigational Site Number 392049
city: Saitama-Shi
country: Japan
facility: Investigational Site Number 392072
city: Sakai-Shi
country: Japan
facility: Investigational Site Number 392075
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392014
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392068
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392073
city: Sasebo-Shi
country: Japan
facility: Investigational Site Number 392006
city: Sendai-Shi
country: Japan
facility: Investigational Site Number 392021
city: Sendai-Shi
country: Japan
facility: Investigational Site Number 392022
city: Sendai-Shi
country: Japan
facility: Investigational Site Number 392033
city: Sendai-Shi
country: Japan
facility: Investigational Site Number 392071
city: Sendai-Shi
country: Japan
facility: Investigational Site Number 392100
city: Shizuoka-Shi
country: Japan
facility: Investigational Site Number 392029
city: Sumida-Ku
country: Japan
facility: Investigational Site Number 392025
city: Sumida-Ku
country: Japan
facility: Investigational Site Number 392092
city: Takaoka-Shi
country: Japan
facility: Investigational Site Number 392023
city: Takarazuka-Shi
country: Japan
facility: Investigational Site Number 392095
city: Takasaki-Shi
country: Japan
facility: Investigational Site Number 392020
city: Takatsuki-Shi
country: Japan
facility: Investigational Site Number 392088
city: Tokorozawa-Shi
country: Japan
facility: Investigational Site Number 392018
city: Tomakomai-Shi
country: Japan
facility: Investigational Site Number 392003
city: Tomakomai-Shi
country: Japan
facility: Investigational Site Number 392005
city: Tonami-Shi
country: Japan
facility: Investigational Site Number 392077
city: Toshima-Ku
country: Japan
facility: Investigational Site Number 392052
city: Toyama-Shi
country: Japan
facility: Investigational Site Number 392058
city: Toyonaka-Shi
country: Japan
facility: Investigational Site Number 392055
city: Urasoe-Shi
country: Japan
facility: Investigational Site Number 392074
city: Urayasu-Shi
country: Japan
facility: Investigational Site Number 392079
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392048
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392090
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392101
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.