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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

March 31, 2011
October 21, 2011
May 2011
September 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01328522 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients
Not Provided

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.

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).
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: SAR153191 (REGN88)

Pharmaceutical form:solution

Route of administration: subcutaneous

  • 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.

    Intervention: Drug: SAR153191 (REGN88)
  • 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.

    Intervention: Drug: SAR153191 (REGN88)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2011
September 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01328522
PKM12058, U1111-1119-2883
No
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP