Study 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.
A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib
A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599)
2 other identifiers
interventional
97
7 countries
30
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 with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2019
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2020
CompletedResults Posted
Study results publicly available
September 16, 2021
CompletedSeptember 16, 2021
August 1, 2021
1.3 years
January 8, 2019
August 18, 2021
August 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either having a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
On or after the first dose of study drug in Study M16-763, and up to 30 days after the last dose of study drug in Study M16-763, up to 52 weeks
Secondary Outcomes (17)
Change in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) From Baseline of Study M16-063 at Each Study Visit in Study M16-763
Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063
Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
- +12 more secondary outcomes
Study Arms (6)
ABBV-599 in M16-063/ABBV-599 in M16-763
EXPERIMENTAL60 mg elsubrutinib capsule once a day by mouth for 48 weeks; 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks
ABBV-105 60 mg/UPA placebo
EXPERIMENTAL60 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 20 mg/UPA placebo
EXPERIMENTAL20 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
ABBV-105 5 mg/UPA placebo
EXPERIMENTAL5 mg elsubrutinib capsule once a day by mouth for 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for 48 weeks
UPA 15 mg/ABBV-105 placebo
EXPERIMENTAL15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks; placebo capsule for elsubrutinib once a day by mouth for 48 weeks
Placebo in M16-063/ABBV-599 in M16-763
EXPERIMENTALPlacebo in M16-063; 60 mg elsubrutinib capsule once a day by mouth for 48 weeks and 15 mg film-coated upadacitinib tablet once a day by mouth for 48 weeks in M16-763
Interventions
Elsubrutinib capsule will be administered orally.
Upadacitinib tablet will be administered orally.
Placebo capsule for elsubrutinib will be administered orally.
Upadacitinib placebo tablet will be administered orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (30)
Cliniques Universitaires Saint Luc /ID# 207719
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
UZ Leuven /ID# 207722
Leuven, 3000, Belgium
Rheumatology Research Assoc /ID# 207769
Edmonton, Alberta, T5M 0H4, Canada
Manitoba Clinic /ID# 206852
Winnipeg, Manitoba, R3A 1M3, Canada
CIADS Research Co Ltd /ID# 206853
Winnipeg, Manitoba, R3N 0K6, Canada
Mount Sinai Hosp.-Toronto /ID# 206851
Toronto, Ontario, M5G 1X5, Canada
Dr. Latha Naik /ID# 213440
Saskatoon, Saskatchewan, S7K 3H3, Canada
Revmatolog s.r.o. /ID# 209941
Jihlava, Jihlava, 586 01, Czechia
Revmatologicky ustav Praha /ID# 209943
Prague, Praha 2, 128 00, Czechia
Revmatologie MUDr. Klara Sirova /ID# 209944
Ostrava, 702 00, Czechia
CCR Czech a.s /ID# 209942
Pardubice, 530 02, Czechia
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 208186
Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 208184
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Revita Reumatologiai Rendelo /ID# 208187
Budapest, 1027, Hungary
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 208188
Székesfehérvár, 8000, Hungary
Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 208185
Veszprém, 8200, Hungary
Malopolskie Centrum Kliniczne /ID# 209902
Krakow, Lesser Poland Voivodeship, 30-149, Poland
McBk Sc /Id# 212577
Grodzisk Mazowiecki, Masovian Voivodeship, 05-825, Poland
NBR Polska /ID# 209904
Warsaw, Masovian Voivodeship, 00-465, Poland
ClinicMed Daniluk, Nowak Sp.j. /ID# 212578
Bialystok, Podlaskie Voivodeship, 15-879, Poland
Reumatika - Centrum Reumatologii NZOZ /ID# 209903
Warsaw, 02-691, Poland
Hospital Universitario A Coruña - CHUAC /ID# 207732
A Coruña, A Coruna, 15006, Spain
Hospital Unversitario Marques de Valdecilla /ID# 207729
Santander, Cantabria, 39008, Spain
Hospital Regional de Malaga /ID# 207735
Málaga, Malaga, 29010, Spain
Hospital Clinic /ID# 207740
Barcelona, 08036, Spain
Hospital Universitario Basurto /ID# 207737
Bilbao, 48013, Spain
Hospital Universitario Virgen de las Nieves /ID# 209975
Granada, 18014, Spain
Hospital Clinico Universitario San Carlos /ID# 207738
Madrid, 28040, Spain
Hospital Universitario y Politecnico La Fe /ID# 207739
Valencia, 46026, Spain
University of Oxford /ID# 210571
Oxford, OX3 7LF, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2019
First Posted
January 30, 2019
Study Start
May 13, 2019
Primary Completion
September 9, 2020
Study Completion
September 9, 2020
Last Updated
September 16, 2021
Results First Posted
September 16, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.