A Randomized, Double-Blind, Phase II Investigator Initiated Trial of Upadacitinib and Short Glucocorticoid Tapering in Giant Cell Arteritis

Giant Cell Arteritis

Percentage of participants achieving sustained remission from week 12 through week 52

Percentage of participants achieving sustained complete remission from week 12 through week 52, Percentage of trial participants achieving com-plete remission at week 26 and week 52, Percentage of trial participants achieving sus-tained remission at week 26 and week 52, Percentage of participants who experience ≥ one disease flare from baseline through Week 52, Number of disease flares per participant from baseline through Week 52, Time to first disease flare from baseline through week 52, Cumulative prednisolone doses from baseline through at week 26 and week 52, Percentage of participants maintaining sustained complete remission off therapy from week 52 through week 78 / Percentage of participants in remission at Week week 78/ Percentage of participants in complete remission at week 78, Percentage of participants with ≥ one disease flare from week 52 through week 78, Number of disease flares per patient from week 52 through week 78, Time to disease flare from week 52 through week 78, Cumulative prednisolone dose from week 52 through week 78, Baseline IMT values and changes at week 26, 52, 78 across all groups. Number of vasculitic vessels identified via ultrasound. Change in OMERACT Giant Cell Arteritis Ultrasonography (OGUS) score during study participation, Prevalence of aortitis at baseline, and week 26, 52, 78. Prevalence of vasculitic involvement of subclavian, axillarian, brachial artery at baseline, and week 26, 52, 78. Quantitative assessment of PET/CT Tracer uptake (Bonn-Score Max) as well as MRI depicted involvement (MRVAS Score) at baseline, and week 26, 52, 78, Occurrence of ocular symptoms and signs re-lated to GCA. Prevalence and longitudinal change in abnormalities in optical coherence tomography angiography (OCTA) (vessel densi-ty, vessel skeleton density and vessel diameter of the superficial retinal layer, deep retinal layer and choriocapillaris layer) at baseline, and week 26, 52, 78, Proportion of subjects with elevated ESR (>20mm/h) and CRP levels (>10mg/L) at every visit, Occurrence of adverse events and serious ad-verse events (severe infections, hepatic disor-ders, hematologic abnormalities, gastrointesti-nal complications and renal impairment) with a focus on adverse events of special interest (AESI) at every visit, Calculation of the Glucocorticoid Toxicity Index (GTI)3 with Composite Worsening Score (CWS) and Aggregate Improvement Score (AIS) at baseline, week 12, 26, 52, 78. Evaluation of the contribution of individual GTI domains, includ-ing BMI, blood pressure, glucose tolerance, lipid metabolism, neuropsychiatric effects, skin toxicity, myopathy, and infection, to the overall GTI score, The change from baseline to week 26, 52, 78in patient-reported outcome measures, as as-sessed by Functional Assessment of Chronic Illness Therapy (FACIT Fatigue), Short Form Health Survey 36 (SF-36), Hospital Anxiety and Depression Scale (HADS), EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L), GCA-Pro, Patient Global Assessment (PGA), The change in the physicians global assess-ment (PhGA) score, and Birmingham Vasculitis Activity Score (BVAS) questionnaire from base-line to week 26, 52, 78

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