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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc.
• Treatments: Belimumab

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.