Rheumatoid Arthritis
Conditions
Brief summary
This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.
Interventions
DRUGREGN88
Single dose of REGN88 and 43 day follow up.
OTHERPlacebo
Placebo to match REGN88 administration
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥18 years of age 2. Subjects must weigh \>50 and \<100 kg 3. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III
Exclusion criteria
1. A history of Listeriosis or active tuberculosis (TB) 2. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit 3. History of prior articular or prosthetic joint infection 4. History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule 5. Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hs-C reactive protein (hs-CRP) | 43 Days |
Secondary
| Measure | Time frame |
|---|---|
| Subject's Assessment of Pain and Subject's Global Assessment of Disease activity | 43 Days |
Countries
Russia
Outcome results
None listed