Clinical trial NCT02373202: A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
Official title: A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2015-02-26
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.

Secondary Objective:

To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.

Detailed description: Total study duration was up to 62 weeks: Up to 4-week screening period, 52-week treatment period, and 6-week post-treatment follow-up period.

Eligibility criteria: Inclusion criteria:

Diagnosis of rheumatoid arthritis (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 4 of 68 tender joints and 4 of 66 swollen joints at screening visit.
* High sensitivity C-Reactive Protein (hs-CRP) \>=4 mg/L or Erythrocyte Sedimentation Rate (ESR) \>=28 mm/hr at screening visit.

For the combination stratum:

Participants who had continuous treatment with non-biologic DMARDs other than MTX for at least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks prior to screening.

For the monotherapy stratum:

Participants who per investigator judgment were any of inappropriate, intolerant or inadequate to MTX treatment.

Exclusion criteria:

Participants \<20 years of age. Prior treatment with tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents 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: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 58
measure: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to Week 58
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
timeFrame: Baseline up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters
timeFrame: Baseline up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes
timeFrame: Baseline up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters
timeFrame: Baseline up to Week 58
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters
timeFrame: Baseline up to Week 58
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52
timeFrame: Week 52
measure: Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP)
timeFrame: Baseline, Week 52
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Asahi-Shi
country: Japan
facility: Investigational Site Number 392010
city: Asahikawa-Shi
country: Japan
facility: Investigational Site Number 392001
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: Fukui-Shi
country: Japan
facility: Investigational Site Number 392004
city: Fukuoka-Shi
country: Japan
facility: Investigational Site Number 392039
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: Kato-Shi
country: Japan
facility: Investigational Site Number 392050
city: Kawachi-Nagano-Shi
country: Japan
facility: Investigational Site Number 392037
city: Kawasaki-Shi
country: Japan
facility: Investigational Site Number 392099
city: Kitakyushu-Shi
country: Japan
facility: Investigational Site Number 392013
city: Kochi-Shi
country: Japan
facility: Investigational Site Number 392097
city: Kushiro-Shi
country: Japan
facility: Investigational Site Number 392065
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392026
city: Miyagi-Gun
country: Japan
facility: Investigational Site Number 392034
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392076
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392080
city: Narashino-Shi
country: Japan
facility: Investigational Site Number 392046
city: Oita-Shi
country: Japan
facility: Investigational Site Number 392059
city: Okayama-Shi
country: Japan
facility: Investigational Site Number 392062
city: Osaki-Shi
country: Japan
facility: Investigational Site Number 392027
city: Sagamihara-Shi
country: Japan
facility: Investigational Site Number 392049
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392014
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392041
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: Shizuoka-Shi
country: Japan
facility: Investigational Site Number 392029
city: Takaoka-Shi
country: Japan
facility: Investigational Site Number 392023
city: Tomakomai-Shi
country: Japan
facility: Investigational Site Number 392003
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
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: