Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT02332590
• Date of registration: 05/01/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)
• Scientific title: A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis
• Date of first enrolment: January 28, 2015
• Target sample size: 369
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02332590
• 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

Chile, Czech Republic, Czechia, France, Germany, Hungary, Israel, Korea, Republic of, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

- Diagnosis of RA greater than or equal to (>=)3 months duration.

- American College of Rheumatology (ACR) Class I-III functional status.

- Active RA was defined as:

At least 6 of 66 swollen joints and 8 of 68 tender joints, high sensitivity C-reactive
protein (hs-CRP) >=8 mg/L or ESR >=28 millimeter per hour (mm/H), and DAS28-ESR greater
than (>) 5.1.

- Participants as per Investigator judgment were either intolerant of, or considered
inappropriate candidates for continued treatment with MTX, or after at least 12 weeks
of continued treatment with MTX, or inadequate responders treated with an adequate MTX
dose for at least 12 weeks.

Exclusion criteria:

- Age <18 years or the legal age of consent in the country of the study site, whichever
was higher.

- Current treatment with disease-modifying antirheumatic drug (DMARDs)/immunosuppressive
agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine,
sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline
(Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to
baseline (Randomization Visit) or leflunomide within 8 weeks prior to the
Randomization Visit, or 4 weeks after cholestyramine washout.

- Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL-6
receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor.

- Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks
prior to screening.

The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Adalimumab

Drug: Placebo (for sarilumab)

Drug: Placebo (for adalimumab)

Drug: Sarilumab

Primary Outcome(s)

DB Period: Change From Baseline in Disease Activity Score for 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 24 [Time Frame: Baseline, Week 24]

Secondary Outcome(s)

DB Period: Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) Scores at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in Short-Form-36 (SF-36) - Physical Component Summary (PCS) Score at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to Arthritis [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to Arthritis [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in Individual ACR Component- ESR Level at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein (HDL) [Time Frame: From Week 0 to Week 24]

DB Period: Change From Baseline in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP Score) at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes [Time Frame: From Week 0 to Week 24]

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function [Time Frame: From Week 0 to Week 24]

DB Period: Change From Baseline in Individual ACR Component - CRP Level at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in WPS-RA at Week 24: Arthritis Interference With Work Productivity [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in HAQ-DI at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by = 50% Due to Arthritis [Time Frame: Baseline, Week 24]

DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities [Time Frame: From Week 0 to Week 24]

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis [Time Frame: From Week 0 to Week 24]

DB Period: Percentage of Participants Achieving ACR50 Criteria at Week 24 [Time Frame: Week 24]

DB Period: Change From Baseline in CDAI at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in SF-36 - Mental Health Component Summary Score at Week 24 [Time Frame: Baseline, Week 24]

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters [Time Frame: From end of Week 24 (Baseline of OLE Period) up to Week 300]

DB Period: Change From Baseline in Individual ACR Component - TJC and SJC at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in Morning Stiffness VAS at Week 24 [Time Frame: Baseline, Week 24]

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters [Time Frame: From Week 0 to Week 24]

DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities [Time Frame: From Week 0 to Week 24]

DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: From Week 0 to Week 24]

DB Period: Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to Arthritis [Time Frame: Baseline, Week 24]

DB Period: Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody (ADA) Response [Time Frame: From Week 0 to Week 24]

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes [Time Frame: From end of Week 24 (Baseline of OLE Period) up to Week 300]

DB Period: Percentage of Participants Achieving ACR70 Criteria at Week 24 [Time Frame: Week 24]

Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody Response During Entire Treatment-emergent Adverse Event Period [Time Frame: From Week 0 up to last dose in OLE + 6 weeks of follow-up (i.e. up to Week 306)]

OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab [Time Frame: Pre-dose at Week 24 (Baseline of OLE period), 36, 48, 60, 84, 108, 132, 156, 180, 204, 228, 252, 276, 300 and 306]

DB Period: Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to Arthritis [Time Frame: Baseline, Week 24]

DB Period: Percentage of Participants Achieving Low Disease Activity (DAS28-ESR < 3.2) at Week 24 [Time Frame: Week 24]

DB Period: Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP <2.6) at Week 24 [Time Frame: Week 24]

DB Period: Percentage of Participants Achieving ACR20 Criteria at Week 24 [Time Frame: Week 24]

DB Period: Percentage of Participants Achieving Clinical Remission Score (DAS28-ESR <2.6) at Week 24 [Time Frame: Week 24]

OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities [Time Frame: From end of Week 24 (Baseline of OLE Period) up to Week 300]

DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab [Time Frame: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, and 24]

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis [Time Frame: From end of Week 24 (Baseline of OLE Period) up to Week 300]

OLE Period: Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events [Time Frame: From end of Week 24 (Baseline of OLE Period) up to last dose in OLE + 6 weeks of follow up (i.e. up to Week 306)]

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function [Time Frame: From end of Week 24 (Baseline of OLE Period) up to Week 300]

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests [Time Frame: From end of Week 24 (Baseline of OLE Period) up to Week 300]

OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities [Time Frame: From end of Week 24 (Baseline of OLE Period) up to Week 300]

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by >= 50% Due to Arthritis [Time Frame: Baseline, Week 24]

DB Period: Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity [Time Frame: Baseline, Week 24]

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters [Time Frame: From Week 0 to Week 24]

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests [Time Frame: From Week 0 to Week 24]

DB Period: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Remission (CDAI =2.8) at Week 24 [Time Frame: Week 24]

OLE Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein [Time Frame: From end of Week 24 (Baseline of OLE Period) up to Week 300]

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters [Time Frame: From end of Week 24 (Baseline of OLE Period) up to Week 300]

Secondary ID(s)

EFC14092

U1111-1160-6154

2014-002541-22

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 25/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02332590