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

September 27, 2013 updated by: Regeneron Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
    • Texas
      • Dallas, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1
First dose of SC REGN88
Biological: REGN88
Single SC Dose
Experimental: Dose 2
Second dose of SC REGN88
Biological: REGN88
Single SC Dose
Experimental: Dose 3
Third dose of SC REGN88
Biological: REGN88
Single SC Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of a single dose of subcutaneously administered REGN88 in subjects with rheumatoid arthritis who are receiving concomitant treatment with methotrexate
Time Frame: 113 Days
113 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the PK profile of a single subcutaneous (SC) dose of REGN88, and the immunogenicity of a single SC dose of REGN88
Time Frame: 113 days
113 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Investigators

  • Study Director: Allen Radin, M.D., Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

September 30, 2013

Last Update Submitted That Met QC Criteria

September 27, 2013

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6R88-RA-0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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