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Keep this study
Lead
Human Genome Sciences Inc.
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Have completed the LBRA01 trial.
2. Have achieved at least an ACR20 response at the end of LBRA01.
You may not be if
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.
