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

This study has been terminated.
(Sponsor decision - not related to safety)
Sponsor:
Information provided by (Responsible Party):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00583557
First received: December 20, 2007
Last updated: August 1, 2013
Last verified: August 2013
  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 2

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

Resource links provided by NLM:


Further study details as provided by Human Genome Sciences Inc.:

Primary Outcome Measures:
  • To Evaluate the Long-term Safety of LymphoStat-B™ in Subjects With RA. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    SEE ALSO ADVERSE EVENT (AE) RESULTS SECTION.


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: up to 5 Years ] [ Designated as safety issue: No ]
    NOT ANALYZED


Enrollment: 155
Study Start Date: January 2005
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belimumab Drug: belimumab
IV 10mg/kg Q28 days
Other Name: LymphoStat-B™

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 48 Study Locations
Sponsors and Collaborators
Human Genome Sciences Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
No publications provided

Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00583557     History of Changes
Other Study ID Numbers: LBRA99
Study First Received: December 20, 2007
Results First Received: April 7, 2011
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health

Keywords provided by Human Genome Sciences Inc.:
Rheumatoid Arthritis
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014