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

NCT ID: NCT01055899

Last Updated: 2013-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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RA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1

First dose of SC REGN88

Group Type EXPERIMENTAL

REGN88

Intervention Type BIOLOGICAL

Single SC Dose

Dose 2

Second dose of SC REGN88

Group Type EXPERIMENTAL

REGN88

Intervention Type BIOLOGICAL

Single SC Dose

Dose 3

Third dose of SC REGN88

Group Type EXPERIMENTAL

REGN88

Intervention Type BIOLOGICAL

Single SC Dose

Interventions

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REGN88

Single SC Dose

Intervention Type BIOLOGICAL

REGN88

Single SC Dose

Intervention Type BIOLOGICAL

REGN88

Single SC Dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allen Radin, M.D.

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Duncansville, Pennsylvania, United States

Site Status

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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6R88-RA-0801

Identifier Type: -

Identifier Source: org_study_id