A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    390
  • sponsor
    AbbVie
Updated on 7 July 2021
Investigator
AbbVie_Call Center
Primary Contact
Dr. Juris Lazovskis Inc. /ID# 224817 (3.0 mi away) Contact
+52 other location
stiffness
DMARD
antirheumatics

Summary

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study will assess how effective Upadacitinib is in changing the disease symptoms in Canadian participants with RA.

Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult Canadian participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 390 participants will be enrolled this study, in multiple sites within Canada.

Participants will receive Upadacitinib as prescribed by the physician and will be followed for approximately 24 months.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Clinical Study IdentifierNCT04574492
SponsorAbbVie
Last Modified on7 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of moderate to severe Rheumatoid Arthritis (RA) according to the investigator
Decision to initiate UPA treatment by investigator according to the local product label independent of the participant's participation in the study
Has been previously treated with Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) and corresponds to one of the following subgroups
Has not been previously exposed to any Biologic Disease-Modifying Antirheumatic Drugs (bDMARD) or Targeted Synthetic Disease-Modifying Antirheumatic Drugs (tsDMARD)
Has not been previously exposed to tsDMARD and has been previously exposed to <= 2 bDMARDs
Has been previously treated with one tsDMARD and <=1 bDMARD prior to treatment with that tsDMARD

Exclusion Criteria

Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the treatment of RA
Diagnosis of rheumatic disease other than RA
Diagnosis of juvenile RA
Currently participating in an investigational clinical trial
Has prior exposure to a bDMARD after exposure to a tsDMARD
Has prior exposure to tsDMARD in an investigational clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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