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

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
belimumab
Sponsored by
Human Genome Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Arizona Arthritis Research
  • Arthritis Health
  • The University of Arizona Health Sciences Center
  • University of Southern CA
  • Wallace Rheumatic Disease Center
  • Boling Clinical Trials
  • Arthritis Care Center, Inc.
  • Arthritis Associates & Osteoporosis Center of Colorado Springs
  • Washington Hospital Center
  • Arthritis and Rheumatic Disease Specialties
  • Rheumatology Associates of Central Florida
  • Tampa Medical Group, P.A.
  • Radiant Research Boise
  • Rheumatology Associates
  • Medical Specialists
  • Kentuckiana Center for Better Bone and Joint Health
  • The Osteoporosis and Arthritis Clinical Trial Center
  • Center for Rheumatology and Bone Research
  • Mayo Clinic
  • Washington University in St. Louis
  • Arthritis Center of Nebraska
  • Strafford Medical Associates, P.A.
  • The Center for Rheumatology
  • North Shore University Hospital
  • Arthritis Clinic and Carolina Bone and Joint
  • Wake Forest Unviersity School of Medicine
  • Bone and Joint Hospital - Research Department
  • Oklahoma Medical Reseach Foundation
  • Oklahoma Center for Arthritis Therapy & Research
  • University of Pittsburgh School of Medicine & ASPH
  • Rheumatic Disease Associates
  • Arthritis Centers of Texas
  • UT Southwestern Medical Center at Dallas
  • Houston Institute for Clinical Research
  • Texas Research Center
  • IPC Clinical Research
  • Arthritis Clinic of Northern Virginia, P.C.
  • Seattle Arthritis Clinic
  • Arthritis Northwest Rheumatology
  • Rheumatology Northwest Clinical Trials
  • Rheumatic Disease Center
  • Gundersen Clinic, LTD
  • Marshfield Medical Research Foundation
  • NZOZ Centrum Medyczne
  • Wojewodzki Zespol Reumatologiczny
  • Instytut Reumaologii
  • Instytut Reumatologii

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Belimumab

Arm Description

Outcomes

Primary Outcome Measures

To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.

Secondary Outcome Measures

The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
NOT ANALYZED

Full Information

First Posted
December 20, 2007
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00583557
Brief Title
A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision - not related to safety
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, RA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Belimumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
belimumab
Other Intervention Name(s)
LymphoStat-B™
Intervention Description
IV 10mg/kg Q28 days
Primary Outcome Measure Information:
Title
To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
Description
SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
Description
NOT ANALYZED
Time Frame
up to 5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Inclusion Criteria: Have completed the LBRA01 trial. Have achieved at least an ACR20 response at the end of LBRA01. Primary Exclusion Criteria: 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. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Arthritis Research
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Arthritis Health
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
The University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Southern CA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Wallace Rheumatic Disease Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Boling Clinical Trials
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Arthritis Care Center, Inc.
City
San Jose
State/Province
California
ZIP/Postal Code
95126
Country
United States
Facility Name
Arthritis Associates & Osteoporosis Center of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Washington Hospital Center
City
Washington, DC
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Arthritis and Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Tampa Medical Group, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Radiant Research Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Rheumatology Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Medical Specialists
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Kentuckiana Center for Better Bone and Joint Health
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The Osteoporosis and Arthritis Clinical Trial Center
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University in St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Arthritis Center of Nebraska
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Strafford Medical Associates, P.A.
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Arthritis Clinic and Carolina Bone and Joint
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Wake Forest Unviersity School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27599-7280
Country
United States
Facility Name
Bone and Joint Hospital - Research Department
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oklahoma Medical Reseach Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Oklahoma Center for Arthritis Therapy & Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
University of Pittsburgh School of Medicine & ASPH
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Rheumatic Disease Associates
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Arthritis Centers of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8884
Country
United States
Facility Name
Houston Institute for Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Texas Research Center
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
IPC Clinical Research
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Arthritis Clinic of Northern Virginia, P.C.
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Seattle Arthritis Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Arthritis Northwest Rheumatology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Rheumatology Northwest Clinical Trials
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Gundersen Clinic, LTD
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54610
Country
United States
Facility Name
Marshfield Medical Research Foundation
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
NZOZ Centrum Medyczne
City
Bialystok
Country
Poland
Facility Name
Wojewodzki Zespol Reumatologiczny
City
Sopot
Country
Poland
Facility Name
Instytut Reumaologii
City
Warszawa
Country
Poland
Facility Name
Instytut Reumatologii
City
Warszawa
Country
Poland

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/ct2/show/NCT00071812?term=lbra01&rank=2
Description
ClinicalTrials.gov Posting for Parent Protocol LBRA01

Learn more about this trial

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

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