Last updated 21 days ago
Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis
480 patients around the world
Available in Puerto Rico, Chile, United States, Argentina
AbbVie
20Research sites
480Patients around the world
This study is for people with
Arthritis
Rheumatoid arthritis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Diagnosis of Rheumatoid Arthritis (RA) for >= 3 months based on the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for RA.Treated for >= 3 consecutive months prior to screening with 1 tumor necrosis factor inhibitor (TNFi) (originator or biosimilar) for RA (except adalimumab [originator or biosimilar]), but continue to exhibit active RA, or had to discontinue due to intolerability, irrespective of treatment duration. Up to 15% of participants who were intolerant to 1 TNFi will be allowed to enroll.On oral or parenteral methotrexate (MTX) therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. In addition, all participants should take a dietary supplement of folic acid or folinic acid throughout the study participation.For participants in China, Japan, Korea, or Taiwan, a stable dose of MTX >= 7.5 mg/week is acceptable. Additional local requirements for MTX may apply.Meets both of the following disease activity criteria:>= 6 swollen joint (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at screening and baseline;High-sensitivity C-reactive protein (hsCRP) >= 3 mg/L (central lab, upper limit of normal [ULN] 2.87 mg/L) at screening.
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than Rheumatoid Arthritis (RA).Prior exposure to any janus kinase (JAK) inhibitor.Prior exposure to adalimumab (original or biosimilar).Prior exposure to a non-TNFi biologic disease modifying anti-rheumatic drug (bDMARD).
Sites
Instituto Médico de Alta Complejidad San Isidro IMACSI
Consultorios Reumatológicos Pampa
Organización Médica de Investigación (OMI)
Recruiting
Instituto Médico Damic S.R.L.
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
CEDIMBA - DIM Clínica Privada - Buenos Aires
Centro Integral de Reumatología - Tucumán
Centro de Investigaciones Médicas Tucumán
Recruiting
Hospital Italiano de La Plata
Instituto CAICI - Rosario, Santa Fe
StudySELECT- SWITCH
SponsorAbbVie
Conditions
Rheumatoid arthritis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05814627
