Continuation of Efficacy and Safety of Belimumab in Subjects with SLE

• Research type

  Research Study

• Full title

  A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-BTM), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057

• IRAS ID

  16592

• Sponsor organisation

  Human Genome Sciences Inc

• Eudract number

  2007-007648-85

• Clinicaltrials.gov Identifier

  NCT00712933

• Research summary

  This study is a continuation of a clinical trial of belimumab (a drug being studied for treating Systemic Lupus Erythematosus ?? SLE, which is given by an infusion in to a vein) given together with standard of care in SLE patients who have completed the original randomised controlled study (HGS1006-C1056). Patients who tolerated belimumab in the original randomised controlled study who wish to continue to receive the drug may do so in the continuation study. In addition, those patients who did not receive belimumab but received placebo plus their standard of care in the original study will receive belimumab plus SOC in this continuation study.The purpose of this continuation study is to provide continuing treatment with belimumab to all patients who completed original study and wish to continue,and to evaluate the long-term effects of belimumab in patients with SLE.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/10

• Date of REC Opinion

  13 Mar 2009

• REC opinion

  Further Information Favourable Opinion