A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects

September 27, 2013 updated by: Regeneron Pharmaceuticals

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Parallel-group Study of the Safety and Tolerability of REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

This is a randomized study of the safety and tolerability of multiple doses of REGN88 in rheumatoid arthritis patients who are receiving treatment with methotrexate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-centered, randomized, double-blind, placebo-controlled, ascending parallel-group study of the safety and tolerability of REGN88 in patients with rheumatoid arthritis who are receiving concomitant methotrexate.

This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will not begin until enrollment in Part B is complete.

Study Type

Interventional

Enrollment (Actual)

60

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
    • California
      • Santa Maria, California, United States
    • Florida
      • Boca Raton, Florida, United States
      • Clearwater, Florida, United States
      • Daytona Beach, Florida, United States
      • Delray Beach, Florida, United States
      • Palm Harbor, Florida, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • Lansing, Michigan, United States
    • Mississippi
      • Flowood, Mississippi, United States
    • Missouri
      • Kalamzaoo, Missouri, United States
      • St. Louis, Missouri, United States
    • Nevada
      • Reno, Nevada, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
    • South Carolina
      • Greenville, South Carolina, United States
      • Orangeburg, South Carolina, United States
    • Tennessee
      • Hixson, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Houston, Texas, United States
      • San Antonio, 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:

  • Patients with an established diagnosis of Rheumatoid Arthritis
  • Patients currently treated with concomitant methotrexate for at least 12 weeks, with a stable dose for at least 6 weeks

Exclusion Criteria:

  • Persistent chronic or current active infections
  • Patients who have taken anakinra within 2 weeks
  • Patients who have taken etanercept, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 4 weeks
  • Patients who have taken adalimumab within 6 weeks
  • Patients who have taken abatacept, azathioprine, cyclophosphamide or infliximab within 12 weeks
  • Patients who have taken leflunomide or rituximab within 6 months
  • Patients who have had prior treatment with tocilizumab or any other anti-IL-6 medication
  • Significant arthritis or other medical condition that could interfere with study evaluations
  • Participation in any clinical research study evaluating another investigational drug within 30 days

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: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
dose 1 vs. placebo
Biological: REGN88
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.
ACTIVE_COMPARATOR: 2
dose 2 vs. placebo
Biological: REGN88
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.
ACTIVE_COMPARATOR: 3
dose 3 vs. placebo
Biological: REGN88
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.
ACTIVE_COMPARATOR: 4
dose 4 vs. placebo
Biological: REGN88
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.
ACTIVE_COMPARATOR: 5
dose 5 vs. placebo
Biological: REGN88
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.
ACTIVE_COMPARATOR: 6
dose 6 vs. placebo
Biological: REGN88
This study will be conducted in 3 parts, and will include a total of 6 dose cohorts. Part B will not begin until the safety of Part A has been assessed. Part C will begin when enrollment into Part B is complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events in patients treated with REGN88 and placebo
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate exploratory efficacy endpoints
Time Frame: over 10 weeks
over 10 weeks

Collaborators and Investigators

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

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

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

December 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (ESTIMATE)

November 11, 2009

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6R88-RA-0802

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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