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NCT04086745: RA-BRANCH
A Study of Baricitinib in Participants With Rheumatoid Arthritis
Phase 4 trial testing Baricitinib in Rheumatoid Arthritis in 1,317 participants. Completed in 19 May 2025.
19 May 2025
Quick facts
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,317 |
| Start date | 14 February 2020 |
| Primary completion | 19 May 2025 |
| Estimated completion | 19 May 2025 |
| Sites | 119 locations across United States |
Drugs / interventions tested
- Baricitinib (baricitinib) — full drug profile →
- TNF Inhibitor (tnf-inhibitor) — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
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):
-
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04086745
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07268534 — Biologics in Folliculitis Decalvans : an Adaptative Trial Research · Phase 2 · not yet recruiting
- NCT06923072 — Baricitinib in the Treatment of Kohlmeier-Degos Disease in Patients With Neurological Involvement · Phase 2 · recruiting
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
- NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
- NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
- NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
- NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
- NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
- NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04086745 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
- Last refreshed: 17 July 2025
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing