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

Sponsor:	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)	Phase II

Human Genome Sciences has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Immunoglobulins Belimumab Globulin, Immune

U.S. FDA Resources

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 ]

Enrollment:	296
Study Start Date:	December 2003
Study Completion Date:	December 2005

Detailed 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 TNFα 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: TNFα-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

Show 63 Study Locations

Sponsors and Collaborators

Human Genome Sciences

Investigators

Study Director:

William Freimuth, MD, PhD

Human Genome Sciences, Inc.

More Information

No publications provided

Responsible Party:	William Freimuth, MD, PhD, Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences, Inc.
ClinicalTrials.gov Identifier:	NCT00071812 History of Changes
Other Study ID Numbers:	LBRA01
Study First Received:	October 31, 2003
Last Updated:	April 9, 2008
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health

Keywords provided by Human Genome Sciences:

RA

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012