A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: REGN88; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01026519

6R88-RA-0803

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups, including a placebo group

Dose 1

Experimental group

Description:

Active dose

Treatment:

Drug: REGN88

Dose 2

Experimental group

Description:

Active dose

Treatment:

Drug: REGN88

Dose 3

Experimental group

Description:

Active 3

Treatment:

Drug: REGN88

Dose 4

Placebo Comparator group

Description:

Placebo dose

Treatment:

Other: Placebo