NCT01858792 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

R
F. van Vollenhoven,1 M.A. Petri,2 R. Cervera,3 D. Roth,4 B. Ji,5 C. Kleoudis,6 Z. John Zhong,7 W. Freimuth,7 for the BLISS-52 and BLISS-76 Study Groups. Response of Systemic Lupus Erythematosus Patients With High Disease Activity to Belimumab Treatment in the BLISS Trials . [Ann Rheum Dis]. 2012;71(8):1343-9.

Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

Details for clinical trial NCT01858792

Clinical trial NCT01858792 - References