drugset / Trial / NCT03823378
A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy of ABBV-105 (elsubrutinib \[ELS\]) and ABBV-599 (ELS 60 mg and upadacitinib \[UPA\] 15 mg) in participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).
Timeline
- Start
- 2019-05-13
- Primary completion
- 2020-09-09
- Completion
- 2020-09-09
Outcome
Outcome not reported
Stopped: “Study M16-763 was terminated early as the benefit of each treatment arm from the feeder study (Study M16-063) did not provide appreciable evidence of differentiated clinical effect to warrant further long-term continuation.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elsubrutinib | Small molecule | 5 mg | Oral |
| Subject | Elsubrutinib | Small molecule | 20 mg | Oral |
| Subject | Elsubrutinib | Small molecule | 60 mg | Oral |
| Subject | Upadacitinib | Small molecule | 15 mg | Oral |