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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02293902
• Date of registration: 13/11/2014
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: 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)
• Scientific 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
• Date of first enrolment: November 2014
• Target sample size: 243
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02293902
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Methotrexate

Drug: Folic acid

Drug: Sarilumab SAR153191 (REGN88)

Other: Placebo (for sarilumab)

Primary Outcome(s)

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities [Time Frame: 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]

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters [Time Frame: 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]

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: 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]

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters [Time Frame: 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]

Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities [Time Frame: 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]

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters [Time Frame: 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]

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes [Time Frame: 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]

Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters [Time Frame: 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]

Secondary ID(s)

EFC14059

U1111-1155-7401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 30/01/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02293902