A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: belimumab	Phase II

MedlinePlus related topics:

Rheumatoid Arthritis

Drug Information available for:

Belimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

To evaluate the long-term safety of LymphoStat-B™ in subjects with RA. [ Time Frame: Until the drug is approved ] [ Designated as safety issue: Yes ]

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). [ Time Frame: Until the drug is approved. ] [ Designated as safety issue: No ]

Enrollment:	155
Study Start Date:	January 2005
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: belimumab IV 10mg/kg Q28 days

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583557

Show 62 Study Locations

Sponsors and Collaborators

Human Genome Sciences

Investigators


Study Director:	William Freimuth, MD, PhD	Human Genome Sciences, Inc.

More Information

Responsible Party:	Human Genome Sciences ( William Freimuth, MD, PhD/Vice President, Clinical Research Immunology, Rheumatology & Infectious Diseases )
Study ID Numbers:	LBRA99
First Received:	December 20, 2007
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00583557
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health

Keywords provided by Human Genome Sciences:

Rheumatoid Arthritis

RA

Study placed in the following topic categories:

Antibodies

Autoimmune Diseases

Musculoskeletal Diseases

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00583557