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

Study Identifier
P20-096
CT.gov Identifier
NCT04574492
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Rheumatology Research Associates /ID# 224534
    Edmonton, Alberta, Canada, T5M 0H4
    Status
    Not applicable
    Location
    Saurash Reddy Professional Corporation /ID# 225288
    Edmonton, Alberta, Canada, T6G 0T2
    Status
    Not applicable
    Location
    Fraser Clinical Trials Inc /ID# 225200
    New Westminster, British Columbia, Canada, V3L 3W4
    Status
    Not applicable
    Location
    Dr. Jonathan D. Chan Inc. /ID# 222976
    Vancouver, British Columbia, Canada, V5Z 1J9
    Status
    Not applicable
    Location
    Dr. Milton F. Baker Inc. /ID# 224555
    Victoria, British Columbia, Canada, V8P 5P6
    Status
    Not applicable
    Location
    Manitoba Clinic /ID# 223288
    Winnipeg, Manitoba, Canada, R3A 1M3
    Status
    Not applicable
    Showing {first} - {last} of {total} Results