Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
Phase 3
1,000
about 4.3 years
18–63
132 sites in AR, AZ, CA +25
What this study is about
This trial is testing a treatment called upadacitinib for adults with moderate to severe systemic lupus erythematosus (SLE). The goal is to see if this treatment is safe and effective, and to monitor any side effects or changes in disease activity. Participants will take either upadacitinib or a placebo daily for 52 weeks.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo
- 2.Take Upadacitinib
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
upadacitinib
oral (Oral Solution)
Secondary: Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS), Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4, Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)
Immune