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ClinicalTrials.gov Identifier : NCT03682705  

A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis.

    Status Recruiting
    Related Conditions
    Rheumatoid Arthritis (RA)

Enrollment Details

240 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type II phase trial.

Protocol ID
M16-063

Brief summary

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This is a phase 2 study to evaluate safety and efficacy of ABBV-105 and ABBV-599 (ABBV-105 plus upadacitinib) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDS) for the treatment of signs and symptoms of Rheumatoid Arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs(bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.

Participant Attributes :
  • Male and Female
  • Ages 18 Years and older

Canada: 5

0
Edmonton, AB
1
Winnipeg, MB
2
Winnipeg, MB
3
Mississauga, ON
4
Toronto, ON
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Randomized

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Observational Model

    Randomized

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Diagnosis of RA for >=3 months based on the 2010 ACR/EULAR classification criteria for RA.
    • Participant meets the following minimum disease activity criteria:
      1. >=6 swollen joints (based on 66 joint counts) and >=6 tender joints (based on 68 joint counts) at Screening and Baseline Visits
      2. hsCRP >=3 mg/L (central lab) at Screening Visit.
    • Participants must have been treated for >=3 months with >=1 bDMARD therapy but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration.
    • Participants must have been receiving csDMARD therapy >=3 months and on a stable dose for >=4 weeks prior to the first dose of study drug.
    • Participants must have discontinued all bDMARDs prior to the first dose of study drug.
    • Participants have prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib).

More on this trial

Clinical Trials.gov