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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00583557
• Other study ID #: LBRA99
• Status: Terminated
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: August 1, 2013
• Start date: January 2005
• Est. completion date: November 2009

Study information

• Verified date: August 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 155
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• belimumab
IV 10mg/kg Q28 days

Locations

Country	Name	City	State
Poland	NZOZ Centrum Medyczne	Bialystok
Poland	Wojewodzki Zespol Reumatologiczny	Sopot
Poland	Instytut Reumaologii	Warszawa
Poland	Instytut Reumatologii	Warszawa
United States	The Center for Rheumatology	Albany	New York
United States	Arthritis Clinic of Northern Virginia, P.C.	Arlington	Virginia
United States	Arthritis and Rheumatic Disease Specialties	Aventura	Florida
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Radiant Research Boise	Boise	Idaho
United States	Arthritis Clinic and Carolina Bone and Joint	Charlotte	North Carolina
United States	Rheumatology Associates	Chicago	Illinois
United States	Arthritis Associates & Osteoporosis Center of Colorado Springs	Colorado Springs	Colorado
United States	The Osteoporosis and Arthritis Clinical Trial Center	Cumberland	Maryland
United States	Arthritis Centers of Texas	Dallas	Texas
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Strafford Medical Associates, P.A.	Dover	New Hampshire
United States	Rheumatic Disease Center	Glendale	Wisconsin
United States	Houston Institute for Clinical Research	Houston	Texas
United States	Gundersen Clinic, LTD	La Crosse	Wisconsin
United States	Arthritis Center of Nebraska	Lincoln	Nebraska
United States	University of Southern CA	Los Angeles	California
United States	Wallace Rheumatic Disease Center	Los Angeles	California
United States	Kentuckiana Center for Better Bone and Joint Health	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Medical Specialists	Munster	Indiana
United States	IPC Clinical Research	Ogden	Utah
United States	Bone and Joint Hospital - Research Department	Oklahoma City	Oklahoma
United States	Oklahoma Medical Reseach Foundation	Oklahoma City	Oklahoma
United States	Rheumatology Associates of Central Florida	Orlando	Florida
United States	Arizona Arthritis Research	Paradise Valley	Arizona
United States	University of Pittsburgh School of Medicine & ASPH	Pittsburgh	Pennsylvania
United States	Boling Clinical Trials	Rancho Cucamonga	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Arthritis Care Center, Inc.	San Jose	California
United States	Arthritis Health	Scottsdale	Arizona
United States	Seattle Arthritis Clinic	Seattle	Washington
United States	Arthritis Northwest Rheumatology	Spokane	Washington
United States	Washington University in St. Louis	St. Louis	Missouri
United States	Texas Research Center	Sugar Land	Texas
United States	Tampa Medical Group, P.A.	Tampa	Florida
United States	The University of Arizona Health Sciences Center	Tucson	Arizona
United States	Oklahoma Center for Arthritis Therapy & Research	Tulsa	Oklahoma
United States	Washington Hospital Center	Washington, DC	District of Columbia
United States	Marshfield Medical Research Foundation	Wausau	Wisconsin
United States	Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Rheumatic Disease Associates	Willow Grove	Pennsylvania
United States	Wake Forest Unviersity School of Medicine	Winston-Salem	North Carolina
United States	Rheumatology Northwest Clinical Trials	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA.	SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.	Up to 5 years	Yes
Secondary	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	up to 5 Years	No

External Links

•   ClinicalTrials.gov Posting for Parent Protocol LBRA01