A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01
This study has been terminated.
(Sponsor decision - not related to safety)
Information provided by (Responsible Party):
Human Genome Sciences Inc.
First received: December 20, 2007
Last updated: August 1, 2013
Last verified: August 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2009 (Final data collection date for primary outcome measure)
IV 10mg/kg Q28 days
Other Name: LymphoStat-B™
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).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583557
Human Genome Sciences Inc.
||GSK Clinical Trials
No publications provided
||Human Genome Sciences Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 20, 2007
|Results First Received:
||April 7, 2011
||August 1, 2013
||United States: Food and Drug Administration
Poland: Ministry of Health
Keywords provided by Human Genome Sciences Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Connective Tissue Diseases
Immune System Diseases