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

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328522
• Other study ID #: PKM12058
• Secondary ID: U1111-1119-2883
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2011
• Last updated: October 21, 2011
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SAR153191 (REGN88)
Pharmaceutical form:solution Route of administration: subcutaneous

Locations

Country	Name	City	State
United States	Investigational Site Number 840003	Beverly Hills	California
United States	Investigational Site Number 840002	Dallas	Texas
United States	Investigational Site Number 840004	Duncansville	Pennsylvania
United States	Investigational Site Number 840001	Ocala	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of potentially clinically significant abnormalities in clinical laboratory test results		5 weeks	Yes
Primary	Occurrence of Adverse Events		5 weeks	Yes
Secondary	Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire		2 days	Yes
Secondary	Pain evaluation using Visual Analog Scale (VAS)		2 days	Yes
Secondary	Diameter of the erythema at injection site		2 days	Yes
Secondary	Diameter of the edema at injection site		2 days	Yes
Secondary	Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC)		5 weeks	No