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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01328522
First received: March 31, 2011
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: SAR153191 (REGN88)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Occurrence of potentially clinically significant abnormalities in clinical laboratory test results [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • Occurrence of Adverse Events [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  • Pain evaluation using Visual Analog Scale (VAS) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  • Diameter of the erythema at injection site [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  • Diameter of the edema at injection site [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR153191 drug product 1

SAR153191 drug product 1 in a single injection.

Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Drug: SAR153191 (REGN88)

Pharmaceutical form:solution

Route of administration: subcutaneous

Experimental: SAR153191 drug product 2

SAR153191 drug product 2 in a single injection.

Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Drug: SAR153191 (REGN88)

Pharmaceutical form:solution

Route of administration: subcutaneous


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).
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328522

Locations
United States, California
Investigational Site Number 840003
Beverly Hills, California, United States, 90211
United States, Florida
Investigational Site Number 840001
Ocala, Florida, United States, 34471
United States, Pennsylvania
Investigational Site Number 840004
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Investigational Site Number 840002
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01328522     History of Changes
Other Study ID Numbers: PKM12058, U1111-1119-2883
Study First Received: March 31, 2011
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014