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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Sarilumab; Drug: Tocilizumab

• Registration Number: NCT02097524
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-27
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

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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/ exclusion criteria are listed.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarilumab - dose 1	Sarilumab	Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Tocilizumab - dose 2	Tocilizumab	Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
Tocilizumab - dose 1	Tocilizumab	Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
Sarilumab - dose 2	Sarilumab	Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)