Clinical trial NCT01328522: Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2011-04-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Occurrence of potentially clinically significant abnormalities in clinical laboratory test results
timeFrame: 5 weeks
measure: Occurrence of Adverse Events
timeFrame: 5 weeks
Secondary outcomes:
measure: Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire
timeFrame: 2 days
measure: Pain evaluation using Visual Analog Scale (VAS)
timeFrame: 2 days
measure: Diameter of the erythema at injection site
timeFrame: 2 days
measure: Diameter of the edema at injection site
timeFrame: 2 days
measure: Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC)
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Investigational Site Number 840003
state: California
city: Ocala
country: United States
facility: Investigational Site Number 840001
state: Florida
city: Duncansville
country: United States
facility: Investigational Site Number 840004
state: Pennsylvania
city: Dallas
country: United States
facility: Investigational Site Number 840002
state: Texas
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: