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.
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
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 September 22, 2014
Connective Tissue Diseases
Immune System Diseases
Physiological Effects of Drugs