A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,629actual
Sites
370
Countries
Argentina, Australia, Austria +41
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 | 2015-12-01 | actual | When the study began enrolling |
| Primary completion | 2017-10-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2015-12-14 | estimated | When this record first appeared on the registry |
| Results posted | 2019-10-07 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-08-05 | 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: Placebo for Adalimumab
- Drug: Adalimumab — also filed as Humira
- Drug: Placebo for Upadacitinib
- Drug: Upadacitinib — also filed as ABT-494
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
measured Baseline and Week 12
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
measured Week 12
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2017-12-01 · 4.2 MB · Prot_000.pdf
Statistical Analysis Planposted 2017-12-07 · 1.4 MB · SAP_001.pdf
Publications
- PMID 31287230 — cited as background
- PMID 42342288 — linked by the registry
- PMID 40875187 — linked by the registry
- PMID 40803820 — linked by the registry
- PMID 40514717 — linked by the registry
- PMID 38806190 — linked by the registry
- PMID 38498140 — linked by the registry
- PMID 37982966 — linked by the registry
- PMID 37945286 — linked by the registry
- PMID 37308218 — linked by the registry
- PMID 36794283 — linked by the registry
- PMID 36754548 — linked by the registry
- PMID 36715850 — linked by the registry
- PMID 36125701 — linked by the registry
- PMID 36018230 — linked by the registry
- PMID 34897366 — linked by the registry
- PMID 34041702 — linked by the registry
- PMID 33590829 — linked by the registry
- PMID 33148701 — linked by the registry
- PMID 33115760 — linked by the registry
- PMID 31610021 — linked by the registry
- PMID 31362993 — 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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