Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)

Conditions

Rheumatoid Arthritis

Brief summary

The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.

Anne Paccaly, Pavel Kovalenko, Janie Parrino, Anita Boyapati, Christine Xu et al. (9 authors)

The Journal of Clinical Pharmacology2020-07-2936 citations

10.1002/jcph.1703

Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis

Pavel Kovalenko, Anne Paccaly, Anita Boyapati, Christine Xu, Gregory St John et al. (9 authors)

CPT Pharmacometrics & Systems Pharmacology2020-05-269 citations

10.1002/psp4.12534

Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis

Paul Emery, Juan Rondon, Janie Parrino, Yong Lin, Claudia Pena-Rossi et al. (11 authors)

Lara D. Veeken2018-11-22123 citations

10.1093/rheumatology/key361

Interventions

DRUGSarilumab

DRUGTocilizumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Patients with RA as defined by the 2010 revised American College of Rheumatology (ACR) 2. ACR Class I-III functional status, based on the 1991 revised criteria 3. Treated for a minimum of 12 weeks with Methotrexate with a stable dose of MTX for at least 8 weeks prior to screening visit

Exclusion criteria

1. Patients less than 18 years of age or minimum legal age 2. Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R) antagonists 3. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening 4. Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to randomization 5. Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer 6. Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other than MTX, within a certain amount of time prior to screening visit 7. Active or suspected TB or at high risk of contracting TB 8. Fever, or chronic, persistent, or recurring infections requiring active treatment 9. HIV positive Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/

Design outcomes

Primary

Measure	Time frame	Description
PD parameters	baseline through week 4	Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4: * the time to nadir (or peak) * change from baseline * area under the curve (AUC)

Secondary

Measure	Time frame	Description
Percentage of TEAEs	baseline through week 6	Percentage of patients with treatment-emergent adverse events (TEAEs) from baseline through end of study (week 6).
PK parameters	baseline through week 4	Pharmacokinetic (PK) parameters, what the body does to a drug, will be collected from baseline through week 4: * AUC * CL (clearance) * Cmax (the peak concentration) * t1/2 (observed terminal half-life)

Countries

United States

Outcome results

None listed