Research

A Safety and Efficacy Study of LymphoStat-B? (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

This study has been completed.

Verified By Human Genome Sciences, April 2008

Sponsors:	Human Genome Sciences
Information Provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00071812

Purpose

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with RA.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: belimumab (LymphoStat-B)	Phase2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B? Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

Further study details as provided by Human Genome Sciences

Primary Outcome Measures:

To evaluate the safety and tolerability of LymphoStat-B? in subjects with RA. [ Time Frame: December 2005 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the efficacy of LymphoStat-B? in subjects with RA. [ Time Frame: December 2005 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	296
Study Start Date:	December 2003

Intervention Details:

Drug:

belimumab (LymphoStat-B)

Detail Description:

The purpose of this study is to evaluate the safety and efficacy of three different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with RA.

Eligibility

Ages Eligible for Study:	18 Years To 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Primary Inclusion Criteria:

Diagnosis of RA for at least 1 year
Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and TNF? inhibitors (infliximab, etanercept or adalimumab)
Active RA disease of at least moderate disease activity
Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable dose for the last 30 days

Primary Exclusion Criteria:

Received a non-FDA approved investigational agent within the last 28 days
Currently receiving or received within the last 60 days the following:

TNF?-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra)

Currently receiving or received within the last 6 months the following: anti-CD20 antibody(rituximab)or cyclophosphamide
Steroid injection into any joint within the last 30 days
History of hypogammaglobulinemia or IgA deficiency
History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days
HIV, Hepatitis-B, Hepatitis-C

Contacts And Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071812

Locations

Wake Forest University School of Medicine

Winston-Salem North Carolina, 27157

Sponsors And Collaborators

Human Genome Sciences

Investigators

Study Director:

William Freimuth, MD, PhD

Human Genome Sciences, Inc.

More Information

Study ID Numbers:	LBRA01
Study First Received:	2003-10-31
Last Updated:	2008-04-09
ClinicalTrials.gov Identifier:	NCT00071812
Health Authority:	United States: Food and Drug Administration

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