Last updated 5 days ago
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
1000 patients around the world
Available in Puerto Rico, Spain, Brazil, United States
AbbVie
16Research sites
1000Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
To 63 Years
All Gender
Medical requirements
- Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.At Screening, must have at least one of the following.Antinuclear antibody (ANA) positive (titer >= 1:80).Anti-double stranded deoxyribonucleic acid (dsDNA) positive.Anti-Smith positive.Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) >= 6, of which >= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as >= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.Physician's Global Assessment (PhGA) >= 1 during screening period.On stable background treatment for >= 60 days prior to Baseline (with the exception of oral corticosteroid [OCS], which must be at a stable dose for >=14 days prior to Baseline) with.Antimalarial(s) [hydroxychloroquine <= 400 mg daily, chloroquine <= 500 mg daily, quinacrine <= 100 mg daily].And/or prednisone (or prednisone-equivalent) (<= 20 mg daily).And/or no more than 1 of the following: azathioprine (<= 150 mg daily), 6-mercaptopurine (<= 150 mg daily), mycophenolate mofetil (<= 2 g daily), mycophenolate sodium <= 1,440 mg/day, leflunomide (<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (<= 23.7 mg twice daily), methotrexate (<= 25 mg weekly), or mizoribine (<= 150 mg daily).
- Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.Pregnancy, breastfeeding, or considering becoming pregnant during the study.Clinically relevant or significant ECG abnormalities at Screening.Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.
Sites
Organización Médica de Investigación (OMI)
Fundación Sanatorio Güemes - CABA, Buenos Aires
CER Instituto Médico - Quilmes, Buenos Aires
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Instituto CAICI - Rosario, Santa Fe
Centro de Investigaciones Médicas Tucumán
Instituto Médico Especializado (IME)
Fundación CIDEA - Buenos Aires
Aprillus Asistencia e Investigación
Hospital Italiano de La Plata
StudySELECT-SLE
SponsorAbbVie
Conditions
Systemic lupus erythematosus
Requirements
To 63 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05843643
