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Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAR153191 (REGN88)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Diagnosis of rheumatoid arthritis (RA) > or = 3 months duration.
  • Treated for a minimum of 12 weeks with Methotrexate (MTX) prior to randomization. Treatment must be continued on a stable dose for the duration of the study.

Exclusion criteria:

  • Autoimmune disease other than RA.
  • History of acute inflammatory joint disease other than RA.
  • Surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months.
  • Latent or active tuberculosis.
  • Fever (≥38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections.
  • Received administration of any live (attenuated) vaccine within 3 months prior to the randomization visit (eg, varicella-zoster vaccine, oral polio, rabies).
  • Received tuberculosis vaccination within 12 months prior to screening
  • Prior therapy with a Tumor Necrosis Factor (TNF) antagonist or any other biologic agents within 3 months prior to inclusion.
  • Known latex sensitivity.

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

Sites / Locations

  • Investigational Site Number 840003
  • Investigational Site Number 840001
  • Investigational Site Number 840004
  • Investigational Site Number 840002

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SAR153191 drug product 1

SAR153191 drug product 2

Arm Description

SAR153191 drug product 1 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

SAR153191 drug product 2 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Outcomes

Primary Outcome Measures

Occurrence of potentially clinically significant abnormalities in clinical laboratory test results
Occurrence of Adverse Events

Secondary Outcome Measures

Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire
Pain evaluation using Visual Analog Scale (VAS)
Diameter of the erythema at injection site
Diameter of the edema at injection site
Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC)

Full Information

First Posted
March 31, 2011
Last Updated
October 21, 2011
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01328522
Brief Title
Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients. Secondary Objective: Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.
Detailed Description
The duration of the study period per subject is 5-7 weeks broken down as follows: Screening: 1 to 14 days, Treatment: 1 day (2 overnight stays at the study site), Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR153191 drug product 1
Arm Type
Experimental
Arm Description
SAR153191 drug product 1 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.
Arm Title
SAR153191 drug product 2
Arm Type
Experimental
Arm Description
SAR153191 drug product 2 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.
Intervention Type
Drug
Intervention Name(s)
SAR153191 (REGN88)
Intervention Description
Pharmaceutical form:solution Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Occurrence of potentially clinically significant abnormalities in clinical laboratory test results
Time Frame
5 weeks
Title
Occurrence of Adverse Events
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire
Time Frame
2 days
Title
Pain evaluation using Visual Analog Scale (VAS)
Time Frame
2 days
Title
Diameter of the erythema at injection site
Time Frame
2 days
Title
Diameter of the edema at injection site
Time Frame
2 days
Title
Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC)
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of rheumatoid arthritis (RA) > or = 3 months duration. Treated for a minimum of 12 weeks with Methotrexate (MTX) prior to randomization. Treatment must be continued on a stable dose for the duration of the study. Exclusion criteria: Autoimmune disease other than RA. History of acute inflammatory joint disease other than RA. Surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months. Latent or active tuberculosis. Fever (≥38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections. Received administration of any live (attenuated) vaccine within 3 months prior to the randomization visit (eg, varicella-zoster vaccine, oral polio, rabies). Received tuberculosis vaccination within 12 months prior to screening Prior therapy with a Tumor Necrosis Factor (TNF) antagonist or any other biologic agents within 3 months prior to inclusion. Known latex sensitivity. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840003
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Investigational Site Number 840001
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Investigational Site Number 840004
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Investigational Site Number 840002
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients

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