A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01

August 1, 2013 updated by: Human Genome Sciences Inc.

A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01

This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 2

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

  • Poland
      • Bialystok, Poland
        • NZOZ Centrum Medyczne
      • Sopot, Poland
        • Wojewodzki Zespol Reumatologiczny
      • Warszawa, Poland
        • Instytut Reumatologii
      • Warszawa, Poland
        • Instytut Reumaologii
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
        • Arizona Arthritis Research
      • Scottsdale, Arizona, United States, 85260
        • Arthritis Health
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Health Sciences Center
    • California
      • Los Angeles, California, United States, 90048
        • Wallace Rheumatic Disease Center
      • Los Angeles, California, United States, 90033
        • University of Southern CA
      • Rancho Cucamonga, California, United States, 91730
        • Boling Clinical Trials
      • San Jose, California, United States, 95126
        • Arthritis Care Center, Inc.
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Arthritis Associates & Osteoporosis Center of Colorado Springs
    • District of Columbia
      • Washington, DC, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis and Rheumatic Disease Specialties
      • Orlando, Florida, United States, 32806
        • Rheumatology Associates of Central Florida
      • Tampa, Florida, United States, 33614
        • Tampa Medical Group, P.A.
    • Idaho
      • Boise, Idaho, United States, 83704
        • Radiant Research Boise
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rheumatology Associates
    • Indiana
      • Munster, Indiana, United States, 46321
        • Medical Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Center for Better Bone and Joint Health
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • The Osteoporosis and Arthritis Clinical Trial Center
      • Wheaton, Maryland, United States, 20902
        • Center for Rheumatology and Bone Research
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Arthritis Center of Nebraska
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • Strafford Medical Associates, P.A.
    • New York
      • Albany, New York, United States, 12206
        • The Center for Rheumatology
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Arthritis Clinic and Carolina Bone and Joint
      • Winston-Salem, North Carolina, United States, 27599-7280
        • Wake Forest Unviersity School of Medicine
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Bone and Joint Hospital - Research Department
      • Oklahoma City, Oklahoma, United States, 74114
        • Oklahoma Medical Reseach Foundation
      • Tulsa, Oklahoma, United States, 74114
        • Oklahoma Center For Arthritis Therapy & Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh School of Medicine & ASPH
      • Willow Grove, Pennsylvania, United States, 19090
        • Rheumatic Disease Associates
    • Texas
      • Dallas, Texas, United States, 75246
        • Arthritis Centers of Texas
      • Dallas, Texas, United States, 75390-8884
        • UT Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77074
        • Houston Institute For Clinical Research
      • Sugar Land, Texas, United States, 77479
        • Texas Research Center
    • Utah
      • Ogden, Utah, United States, 84403
        • IPC Clinical Research
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arthritis Clinic Of Northern Virginia, P.C.
    • Washington
      • Seattle, Washington, United States, 98133
        • Seattle Arthritis Clinic
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest Rheumatology
      • Yakima, Washington, United States, 98902
        • Rheumatology Northwest Clinical Trials
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Rheumatic Disease Center
      • La Crosse, Wisconsin, United States, 54610
        • Gundersen Clinic, Ltd
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Medical Research Foundation

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

Primary Inclusion Criteria:

  1. Have completed the LBRA01 trial.
  2. Have achieved at least an ACR20 response at the end of LBRA01.

Primary Exclusion Criteria:

  1. Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA01.
  2. Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA01.

  3. Used prohibited medications during their participation in LBRA01. These medications include the following:

    • Other investigational agents.
    • Biologic response modifiers
    • Cyclophosphamide.
    • Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months).
    • 2 new DMARDs.
    • 1 new DMARD plus high dose prednisone >10 mg/day.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belimumab
Drug: belimumab
IV 10mg/kg Q28 days
Other Names:
  • LymphoStat-B™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
Time Frame: Up to 5 years
SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
Time Frame: up to 5 Years
NOT ANALYZED
up to 5 Years

Collaborators and Investigators

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

Sponsor

Human Genome Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2005

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBRA99

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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