Case Study

Against All Odds: Phase III On A Breakthrough Therapy In Lupus Nephritis

Source: Worldwide Clinical Trials
Lupus Research Alliance Enhances Clinical Trials for Patients

In the face of challenges both predictable and unforeseen, Worldwide Clinical Trials brought our sponsor’s first FDA-approved oral therapy for lupus nephritis (LN) across the finish line on time.

Sponsor Challenges:

Recruitment: Experienced Sites with Inexperienced Patients

Patients at sites with significant experience with LN trials are typically already participating in a study. This study required sites familiar with LN clinical trials with clinically qualifying patients not already participating in LN studies.

Clinical: Unpredictable Medical Events

Within this study, strict protocol adherence would be a challenge. The investigational product was to be administered at the start of a proteinuria flare, so patients needed to recognize symptoms indicating when to visit the site.

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