Clinical trial NCT00583557: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
RA
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-31
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.
timeFrame: Up to 5 years
Secondary outcomes:
measure: The Efficacy Endpoints Will Include Long-term ACR Responses, DAS28 Response, C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), and Rheumatoid Factor (RF).
timeFrame: up to 5 Years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Paradise Valley
country: United States
facility: Arizona Arthritis Research
state: Arizona
city: Scottsdale
country: United States
facility: Arthritis Health
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Health Sciences Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern CA
state: California
city: Los Angeles
country: United States
facility: Wallace Rheumatic Disease Center
state: California
city: Rancho Cucamonga
country: United States
facility: Boling Clinical Trials
state: California
city: San Jose
country: United States
facility: Arthritis Care Center, Inc.
state: California
city: Colorado Springs
country: United States
facility: Arthritis Associates & Osteoporosis Center of Colorado Springs
state: Colorado
city: Washington, DC
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, P.A.
state: Florida
city: Boise
country: United States
facility: Radiant Research Boise
state: Idaho
city: Chicago
country: United States
facility: Rheumatology Associates
state: Illinois
city: Munster
country: United States
facility: Medical Specialists
state: Indiana
city: Louisville
country: United States
facility: Kentuckiana Center for Better Bone and Joint Health
state: Kentucky
city: Cumberland
country: United States
facility: The Osteoporosis and Arthritis Clinical Trial Center
state: Maryland
city: Wheaton
country: United States
facility: Center for Rheumatology and Bone Research
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Lincoln
country: United States
facility: Arthritis Center of Nebraska
state: Nebraska
city: Dover
country: United States
facility: Strafford Medical Associates, P.A.
state: New Hampshire
city: Albany
country: United States
facility: The Center for Rheumatology
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Charlotte
country: United States
facility: Arthritis Clinic and Carolina Bone and Joint
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Unviersity School of Medicine
state: North Carolina
city: Oklahoma City
country: United States
facility: Bone and Joint Hospital - Research Department
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Medical Reseach Foundation
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Center for Arthritis Therapy & Research
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine & ASPH
state: Pennsylvania
city: Willow Grove
country: United States
facility: Rheumatic Disease Associates
state: Pennsylvania
city: Dallas
country: United States
facility: Arthritis Centers of Texas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Houston Institute for Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Texas Research Center
state: Texas
city: Ogden
country: United States
facility: IPC Clinical Research
state: Utah
city: Arlington
country: United States
facility: Arthritis Clinic of Northern Virginia, P.C.
state: Virginia
city: Seattle
country: United States
facility: Seattle Arthritis Clinic
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest Rheumatology
state: Washington
city: Yakima
country: United States
facility: Rheumatology Northwest Clinical Trials
state: Washington
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Clinic, LTD
state: Wisconsin
city: Wausau
country: United States
facility: Marshfield Medical Research Foundation
state: Wisconsin
city: Bialystok
country: Poland
facility: NZOZ Centrum Medyczne
city: Sopot
country: Poland
facility: Wojewodzki Zespol Reumatologiczny
city: Warszawa
country: Poland
facility: Instytut Reumaologii
city: Warszawa
country: Poland
facility: Instytut Reumatologii
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: