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ClinicalTrial.gov Identifier : NCT03823378

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

    Status Enrolling by invitation
    Related Conditions
    Rheumatoid Arthritis (RA)

Enrollment Details

120 Worldwide Enrollment Goal

Phases: 

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

This is a type II phase trial.

Protocol ID
M16-763

Brief summary

Top

This is a long-term extension (LTE) study to assess the safety, tolerability and efficacy of ABBV-105 and ABBV-599 in Rheumatoid Arthritis (RA) participants who have completed M16-063.

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

Canada: 4

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

  • 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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    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

  • •Participant has completed M16-063.
    •Participant has not developed any laboratory or clinical discontinuation criteria as defined in M16-063.
    •Participant is willing and/or able to comply with procedures required in protocol.

    •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.

More on this trial

Clinical Trials.gov