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NCT04086745: RA-BRANCH

A Study of Baricitinib in Participants With Rheumatoid Arthritis

Completed Phase 4 Last updated 17 July 2025
What this trial tests

Phase 4 trial testing Baricitinib in Rheumatoid Arthritis in 1,317 participants. Completed in 19 May 2025.

Timeline
14 February 2020
Primary endpoint
19 May 2025
19 May 2025

Quick facts

Lead sponsorEli Lilly and Company
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment1,317
Start date14 February 2020
Primary completion19 May 2025
Estimated completion19 May 2025
Sites119 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis (RA).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases.
    Salinas CA, Louder A, Polinski J, Zhang TC, et al · · 2023 · cited 77× · PMID 36371760 · DOI 10.1007/s40744-022-00505-1
  2. A Review of Safety Outcomes from Clinical Trials of Baricitinib in Rheumatology, Dermatology and COVID-19.
    Bieber T, Feist E, Irvine AD, Harigai M, et al · · 2022 · cited 46× · PMID 36063279 · DOI 10.1007/s12325-022-02281-4
  3. A JAK Inhibitor for Treatment of Rheumatoid Arthritis: The Baricitinib Experience.
    Taylor PC, Laedermann C, Alten R, Feist E, et al · · 2023 · cited 25× · PMID 37445562 · DOI 10.3390/jcm12134527
  4. JAK-Inhibitors - A Story of Success and Adverse Events.
    Wlassits R, Müller M, Fenzl KH, Lamprecht T, et al · · 2024 · cited 12× · PMID 38435420 · DOI 10.2147/oarrr.s436637
  5. Characteristics of Patients Treated with JAK Inhibitors in Rheumatoid Arthritis before versus after VTE Risk Warnings.
    Philippoteaux C, Deprez V, Nottez A, Cailliau E, et al · · 2022 · cited 11× · PMID 36615007 · DOI 10.3390/jcm12010207
  6. Comparative effectiveness of baricitinib and alternative biological DMARDs in a Swiss cohort study of patients with RA.
    Gilbert BTP, Mongin D, Aymon R, Lauper K, et al · · 2024 · cited 4× · PMID 38479734 · DOI 10.1136/bmjopen-2023-072300

Verify or expand the search:

Other trials of Baricitinib

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Other recruiting trials for Rheumatoid Arthritis

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Other Eli Lilly and Company trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04086745.

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