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A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

NCT ID: NCT03823378

Last Updated: 2021-09-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2020-09-09

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ABBV-599 in M16-063/ABBV-599 in M16-763

60 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

Group Type EXPERIMENTAL

Elsubrutinib

Intervention Type DRUG

Elsubrutinib capsule will be administered orally.

Upadacitinib

Intervention Type DRUG

Upadacitinib tablet will be administered orally.

ABBV-105 60 mg/UPA placebo

60 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

Group Type EXPERIMENTAL

Elsubrutinib

Intervention Type DRUG

Elsubrutinib capsule will be administered orally.

Placebo for upadacitinib

Intervention Type DRUG

Upadacitinib placebo tablet will be administered orally.

ABBV-105 20 mg/UPA placebo

20 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

Group Type EXPERIMENTAL

Elsubrutinib

Intervention Type DRUG

Elsubrutinib capsule will be administered orally.

Placebo for upadacitinib

Intervention Type DRUG

Upadacitinib placebo tablet will be administered orally.

ABBV-105 5 mg/UPA placebo

5 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

Group Type EXPERIMENTAL

Elsubrutinib

Intervention Type DRUG

Elsubrutinib capsule will be administered orally.

Placebo for upadacitinib

Intervention Type DRUG

Upadacitinib placebo tablet will be administered orally.

UPA 15 mg/ABBV-105 placebo

15 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

Group Type EXPERIMENTAL

Upadacitinib

Intervention Type DRUG

Upadacitinib tablet will be administered orally.

Placebo for elsubrutinib

Intervention Type DRUG

Placebo capsule for elsubrutinib will be administered orally.

Placebo in M16-063/ABBV-599 in M16-763

Placebo 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

Group Type EXPERIMENTAL

Elsubrutinib

Intervention Type DRUG

Elsubrutinib capsule will be administered orally.

Upadacitinib

Intervention Type DRUG

Upadacitinib tablet will be administered orally.

Interventions

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Elsubrutinib

Elsubrutinib capsule will be administered orally.

Intervention Type DRUG

Upadacitinib

Upadacitinib tablet will be administered orally.

Intervention Type DRUG

Placebo for elsubrutinib

Placebo capsule for elsubrutinib will be administered orally.

Intervention Type DRUG

Placebo for upadacitinib

Upadacitinib placebo tablet will be administered orally.

Intervention Type DRUG

Other Intervention Names

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ABBV-105 ABT-494

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Cliniques Universitaires Saint Luc /ID# 207719

Woluwe-Saint-Lambert, Brussels Capital, Belgium

Site Status

UZ Leuven /ID# 207722

Leuven, , Belgium

Site Status

Rheumatology Research Assoc /ID# 207769

Edmonton, Alberta, Canada

Site Status

Manitoba Clinic /ID# 206852

Winnipeg, Manitoba, Canada

Site Status

CIADS Research Co Ltd /ID# 206853

Winnipeg, Manitoba, Canada

Site Status

Mount Sinai Hosp.-Toronto /ID# 206851

Toronto, Ontario, Canada

Site Status

Dr. Latha Naik /ID# 213440

Saskatoon, Saskatchewan, Canada

Site Status

Revmatolog s.r.o. /ID# 209941

Jihlava, Jihlava, Czechia

Site Status

Revmatologicky ustav Praha /ID# 209943

Prague, Praha 2, Czechia

Site Status

Revmatologie MUDr. Klara Sirova /ID# 209944

Ostrava, , Czechia

Site Status

CCR Czech a.s /ID# 209942

Pardubice, , Czechia

Site Status

CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 208186

Miskolc, Borsod-Abauj Zemplen county, Hungary

Site Status

Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatokorhaz /ID# 208184

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Site Status

Revita Reumatologiai Rendelo /ID# 208187

Budapest, , Hungary

Site Status

CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 208188

Székesfehérvár, , Hungary

Site Status

Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 208185

Veszprém, , Hungary

Site Status

Malopolskie Centrum Kliniczne /ID# 209902

Krakow, Lesser Poland Voivodeship, Poland

Site Status

McBk Sc /Id# 212577

Grodzisk Mazowiecki, Masovian Voivodeship, Poland

Site Status

NBR Polska /ID# 209904

Warsaw, Masovian Voivodeship, Poland

Site Status

ClinicMed Daniluk, Nowak Sp.j. /ID# 212578

Bialystok, Podlaskie Voivodeship, Poland

Site Status

Reumatika - Centrum Reumatologii NZOZ /ID# 209903

Warsaw, , Poland

Site Status

Hospital Universitario A Coruña - CHUAC /ID# 207732

A Coruña, A Coruna, Spain

Site Status

Hospital Unversitario Marques de Valdecilla /ID# 207729

Santander, Cantabria, Spain

Site Status

Hospital Regional de Malaga /ID# 207735

Málaga, Malaga, Spain

Site Status

Hospital Clinic /ID# 207740

Barcelona, , Spain

Site Status

Hospital Universitario Basurto /ID# 207737

Bilbao, , Spain

Site Status

Hospital Universitario Virgen de las Nieves /ID# 209975

Granada, , Spain

Site Status

Hospital Clinico Universitario San Carlos /ID# 207738

Madrid, , Spain

Site Status

Hospital Universitario y Politecnico La Fe /ID# 207739

Valencia, , Spain

Site Status

University of Oxford /ID# 210571

Oxford, , United Kingdom

Site Status

Countries

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Belgium Canada Czechia Hungary Poland Spain United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.rxabbvie.com/

Related Info.

Other Identifiers

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2018-002306-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M16-763

Identifier Type: -

Identifier Source: org_study_id

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