Validation of a Novel Outcome Instrument for SLE Clinical Trials Using Phase II Rontalizumab Study Data Set.

Validation of a Novel Outcome Instrument for SLE Clinical Trials Using Phase II Rontalizumab Study Data Set.

Lupus Foundation of Medicine or Lupus Research Alliance

SLE (lupus) is an autoimmune disease that affects about 1.5 million Americans. It has a wide range of symptoms and can affect many parts of the body. It is difficult to determine how patients improve with drugs as there are so many different parts of the body that are involved and they all don't necessarily respond in line with each other. Also, the disease naturally gets better and worsens over time. The purpose of this research is to develop a way to determine if individual patients improve when given a new drug in a way that avoids the hurdles that are in place because of the unique way in which lupus tends to get better and worsen on its own and avoids the problems of different aspects of the disease not acting in sync with others.

[{ "PostingID": 4744, "Title": "ROCHE-IFN4575g", "Description": "A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus Erythematosus" }]