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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

NCT03823378 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2021-09-16

Study results available
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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).

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

Elsubrutinib

Elsubrutinib capsule will be administered orally.

DRUG

Upadacitinib

Upadacitinib tablet will be administered orally.

DRUG

Placebo for elsubrutinib

Placebo capsule for elsubrutinib will be administered orally.

DRUG

Placebo for upadacitinib

Upadacitinib placebo tablet will be administered orally.

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2020-09-09
Completion
2020-09-09
FDA Drug
Yes

Countries

  • Belgium
  • Canada
  • Czechia
  • Hungary
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823378 on ClinicalTrials.gov