Status:
TERMINATED
A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib
Lead Sponsor:
AbbVie
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 w...
Detailed Description
This was a Phase 2, double-blind, multicenter, long-term extension (LTE) study to assess the safety, tolerability, and efficacy of 3 doses of ABBV-105 (elsubrutinib \[ELS\] 5 mg, 20 mg, and 60 mg) and...
Eligibility Criteria
Inclusion
- Participant has completed Study M16-063
- Participant has not developed any laboratory or clinical discontinuation criteria as defined in the Study M16-063 protocol
- Participant is willing and/or able to comply with procedures required in the current study protocol
Exclusion
- Participant is currently enrolled or planning to enroll in another interventional clinical study while participating in this study (except the preceding study M16-063)
- Participant requires vaccination with any live vaccine during study participation, including at least 30 days after the last dose of study drug
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2020
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03823378
Start Date
May 13 2019
End Date
September 9 2020
Last Update
September 16 2021
Active Locations (30)
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1
Cliniques Universitaires Saint Luc /ID# 207719
Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
2
UZ Leuven /ID# 207722
Leuven, Belgium, 3000
3
Rheumatology Research Assoc /ID# 207769
Edmonton, Alberta, Canada, T5M 0H4
4
Manitoba Clinic /ID# 206852
Winnipeg, Manitoba, Canada, R3A 1M3