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

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097524
• Other study ID #: 6R88-RA-1309
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2014
• Last updated: May 4, 2015
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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/ exclusion criteria are listed.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Sarilumab

• Tocilizumab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD parameters	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)	baseline through week 4	No
Secondary	Percentage of TEAEs	Percentage of patients with treatment-emergent adverse events (TEAEs) from baseline through end of study (week 6).	baseline through week 6	Yes
Secondary	PK parameters	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)	baseline through week 4	No