Rheumatoid Arthritis
Conditions
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).
Interventions
Pharmaceutical form:solution Route of administration: subcutaneous
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of potentially clinically significant abnormalities in clinical laboratory test results | 5 weeks |
| Occurrence of Adverse Events | 5 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Diameter of the erythema at injection site | 2 days |
| Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire | 2 days |
| Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC) | 5 weeks |
| Diameter of the edema at injection site | 2 days |
| Pain evaluation using Visual Analog Scale (VAS) | 2 days |
Countries
United States
Outcome results
None listed