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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)

NCT ID: NCT02373202

Last Updated: 2018-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-11-30

Brief Summary

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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.

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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)

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Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

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Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis

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To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sarilumab 150 mg q2w + DMARDs

Participants received sarilumab 150 mg, subcutaneous (SC) injection, once every two weeks (q2w) along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form:solution

Sulfasalazine

Intervention Type DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Leflunomide

Intervention Type DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Bucillamine

Intervention Type DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Tacrolimus

Intervention Type DRUG

Pharmaceutical form: Capsule Route of administration: Oral

Mizoribine

Intervention Type DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Sarilumab 200 mg q2w + DMARDs

Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form:solution

Sulfasalazine

Intervention Type DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Leflunomide

Intervention Type DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Bucillamine

Intervention Type DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Tacrolimus

Intervention Type DRUG

Pharmaceutical form: Capsule Route of administration: Oral

Mizoribine

Intervention Type DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Sarilumab 150 mg q2w

Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form:solution

Sarilumab 200 mg q2w

Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.

Group Type EXPERIMENTAL

Sarilumab

Intervention Type DRUG

Pharmaceutical form:solution

Interventions

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Sarilumab

Pharmaceutical form:solution

Intervention Type DRUG

Sulfasalazine

Pharmaceutical form: Tablet Route of administration: Oral

Intervention Type DRUG

Leflunomide

Pharmaceutical form: Tablet Route of administration: Oral

Intervention Type DRUG

Bucillamine

Pharmaceutical form: Tablet Route of administration: Oral

Intervention Type DRUG

Tacrolimus

Pharmaceutical form: Capsule Route of administration: Oral

Intervention Type DRUG

Mizoribine

Pharmaceutical form: Tablet Route of administration: Oral

Intervention Type DRUG

Other Intervention Names

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SAR153191 (REGN88)

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 392010

Asahi-Shi, , Japan

Site Status

Investigational Site Number 392001

Asahikawa-Shi, , Japan

Site Status

Investigational Site Number 392070

Beppu-Shi, , Japan

Site Status

Investigational Site Number 392036

Chiba, , Japan

Site Status

Investigational Site Number 392083

Chūōku, , Japan

Site Status

Investigational Site Number 392004

Fukui-shi, , Japan

Site Status

Investigational Site Number 392039

Fukuoka, , Japan

Site Status

Investigational Site Number 392030

Ichinomiya-Shi, , Japan

Site Status

Investigational Site Number 392002

Iizuka-Shi, , Japan

Site Status

Investigational Site Number 392019

Kagoshima, , Japan

Site Status

Investigational Site Number 392066

Kamakura-Shi, , Japan

Site Status

Investigational Site Number 392050

Kato-Shi, , Japan

Site Status

Investigational Site Number 392037

Kawachi-Nagano-Shi, , Japan

Site Status

Investigational Site Number 392099

Kawasaki-Shi, , Japan

Site Status

Investigational Site Number 392013

Kitakyushu-Shi, , Japan

Site Status

Investigational Site Number 392097

Kochi, , Japan

Site Status

Investigational Site Number 392065

Kushiro, , Japan

Site Status

Investigational Site Number 392026

Matsuyama, , Japan

Site Status

Investigational Site Number 392034

Miyagi-Gun, , Japan

Site Status

Investigational Site Number 392076

Nagoya, , Japan

Site Status

Investigational Site Number 392080

Nagoya, , Japan

Site Status

Investigational Site Number 392046

Narashino-Shi, , Japan

Site Status

Investigational Site Number 392062

Okayama, , Japan

Site Status

Investigational Site Number 392027

Osaki-Shi, , Japan

Site Status

Investigational Site Number 392059

Ōita, , Japan

Site Status

Investigational Site Number 392049

Sagamihara-Shi, , Japan

Site Status

Investigational Site Number 392014

Sapporo, , Japan

Site Status

Investigational Site Number 392041

Sapporo, , Japan

Site Status

Investigational Site Number 392073

Sapporo, , Japan

Site Status

Investigational Site Number 392006

Sasebo-Shi, , Japan

Site Status

Investigational Site Number 392021

Sendai, , Japan

Site Status

Investigational Site Number 392022

Sendai, , Japan

Site Status

Investigational Site Number 392033

Sendai, , Japan

Site Status

Investigational Site Number 392071

Sendai, , Japan

Site Status

Investigational Site Number 392029

Shizuoka, , Japan

Site Status

Investigational Site Number 392023

Takaoka-Shi, , Japan

Site Status

Investigational Site Number 392003

Tomakomai-Shi, , Japan

Site Status

Investigational Site Number 392074

Urasoe-Shi, , Japan

Site Status

Investigational Site Number 392079

Urayasu-Shi, , Japan

Site Status

Investigational Site Number 392048

Yokohama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1160-6525

Identifier Type: OTHER

Identifier Source: secondary_id

LTS13618

Identifier Type: -

Identifier Source: org_study_id

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