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
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
487actual
Sites
218
Countries
Argentina, Belgium, Brazil +22
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-06-15 | actual | When the study began enrolling |
| Primary completion | 2026-07-15 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-07-15 | actual | The whole study's end, after follow-up |
| First posted | 2023-04-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Rheumatoid Arthritis
Interventions
- Drug: Upadacitinib — also filed as RINVOQ
- Drug: Adalimumab — also filed as Humira
- Drug: Upadacitinib Matching Placebo
- Drug: Adalimumab Matching Placebo
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2
measured Week 12
Number of Participants with Adverse Events
measured From first dose of study drug until 70 days following last dose of study drug (up to approximately 58 weeks)
Publications
- PMID 41991443 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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