Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: REGN88

Study type: Interventional

Funder types: Industry

Identifiers

NCT01055899

6R88-RA-0801

Details and patient eligibility

About

This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.

Full description

This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate.

Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over 16 weeks.

Enrollment: 15 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 kg 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
4. For women of childbearing potential, a negative serum pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at Day -1
5. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study.

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
6. Received administration of any live (attenuated) vaccine within 3 months prior to the Screening Visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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15 participants in 3 patient groups

Dose 1

Experimental group

Description:

First dose of SC REGN88

Treatment:

Biological: REGN88

Biological: REGN88

Biological: REGN88

Dose 2

Experimental group

Description:

Second dose of SC REGN88

Treatment:

Biological: REGN88

Biological: REGN88

Biological: REGN88

Dose 3

Experimental group

Description:

Third dose of SC REGN88

Treatment:

Biological: REGN88

Biological: REGN88

Biological: REGN88