Clinical trial NCT03823378: A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis (RA)
Keywords: Elsubrutinib
ABBV-105
Upadacitinib
ABBV-599
Rheumatoid Arthritis (RA)
Long-term extension (LTE)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 ABBV-599 (ELS 60 mg and upadacitinib \[UPA\] 15 mg) in adults with active rheumatoid arthritis with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs). Participants who successfully completed treatment in the feeder Study M16-063, a Phase 2 dose exploratory study, were eligible to participate in this study. Those who met eligibility criteria and entered this study receiving ELS, ABBV-599, or UPA from Study M16-063 continued on their previously assigned treatment through termination of this study. Participants originally randomized to placebo in Study M16-063 rolled over to ABBV-599 in a blinded fashion in this study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 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:
measure: 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
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
timeFrame: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
timeFrame: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Change in Clinical Disease Activity Index (CDAI) From Baseline of Study M16-063
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Criteria
timeFrame: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Criteria
timeFrame: Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Change in Swollen Joint Count 66 (SJC66) From Baseline of Study M16-063
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Change in Tender Joint Count 68 (TJC68) From Baseline of Study M16-063
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Change in Participant's Assessment of Pain (Visual Analog Scale [VAS]) From Baseline of Study M16-063
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Change in Patient's Global Assessment of Disease Activity (PtGA) From Baseline of Study M16-063
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Change in Physician's Global Assessment of Disease Activity (PhGA) From Baseline of Study M16-063
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Change in Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline of Study M16-063
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Change in High-Sensitivity C-Reactive Protein (Hs-CRP) From Baseline of Study M16-063
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
measure: Change in Morning Stiffness Severity From Baseline of Study M16-063
timeFrame: Baseline in Study M16-063, Weeks 18, 24, 30, 36, 48, and 60 in Study M16-763
Other outcomes:
Locations:
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc /ID# 207719
state: Bruxelles-Capitale
city: Leuven
country: Belgium
facility: UZ Leuven /ID# 207722
city: Edmonton
country: Canada
facility: Rheumatology Research Assoc /ID# 207769
state: Alberta
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 206852
state: Manitoba
city: Winnipeg
country: Canada
facility: CIADS Research Co Ltd /ID# 206853
state: Manitoba
city: Toronto
country: Canada
facility: Mount Sinai Hosp.-Toronto /ID# 206851
state: Ontario
city: Saskatoon
country: Canada
facility: Dr. Latha Naik /ID# 213440
state: Saskatchewan
city: Jihlava 1
country: Czechia
facility: Revmatolog s.r.o. /ID# 209941
state: Jihlava
city: Prague 2
country: Czechia
facility: Revmatologicky ustav Praha /ID# 209943
state: Praha 2
city: Ostrava
country: Czechia
facility: Revmatologie MUDr. Klara Sirova /ID# 209944
city: Pardubice
country: Czechia
facility: CCR Czech a.s /ID# 209942
city: Miskolc
country: Hungary
facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 208186
state: Borsod-Abauj-Zemplen
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 208184
state: Szabolcs-Szatmar-Bereg
city: Budapest
country: Hungary
facility: Revita Reumatologiai Rendelo /ID# 208187
city: Szekesfehervar
country: Hungary
facility: CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 208188
city: Veszprem
country: Hungary
facility: Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 208185
city: Cracow
country: Poland
facility: Malopolskie Centrum Kliniczne /ID# 209902
state: Malopolskie
city: Grodzisk Mazowiecki
country: Poland
facility: McBk Sc /Id# 212577
state: Mazowieckie
city: Warsaw
country: Poland
facility: NBR Polska /ID# 209904
state: Mazowieckie
city: Białystok
country: Poland
facility: ClinicMed Daniluk, Nowak Sp.j. /ID# 212578
state: Podlaskie
city: Warsaw
country: Poland
facility: Reumatika - Centrum Reumatologii NZOZ /ID# 209903
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña - CHUAC /ID# 207732
state: A Coruna
city: Santander
country: Spain
facility: Hospital Unversitario Marques de Valdecilla /ID# 207729
state: Cantabria
city: Málaga
country: Spain
facility: Hospital Regional de Malaga /ID# 207735
state: Malaga
city: Barcelona
country: Spain
facility: Hospital Clinic /ID# 207740
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto /ID# 207737
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 209975
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 207738
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 207739
city: Oxford
country: United Kingdom
facility: University of Oxford /ID# 210571
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: