A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis

Study Identifier
P20-095
CT.gov Identifier
NCT04497597
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
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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:
    * Confirmed diagnosis of moderate to severe active Rheumatoid Arthritis (RA). * Physician decision on patient treatment with upadacitinib must have been reached prior to and independently of recruitment in the study. * Upadacitinib prescribed in accordance to the applicable approved label and local regulatory and reimbursement policies. * French Participants Only: Taking oral glucocorticoids ≥5 mg/day of prednisone or equivalent for at least 3 months prior to study start.
    Exclusion Criteria:
    \- Prior treatment with Upadacitinib.

    Protocol Summary

    Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the treatment patterns, achievement of treatment targets and maintenance of response.

    Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 1660 participants will be enrolled this study, worldwide.

    Participants will not receive Upadacitinib as part of this study, but will be followed for response to treatment for up to 24 months.

    There may be higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits, every 3 months, 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
    Hospital Italiano La Plata /ID# 222190
    La Plata, Buenos Aires, Argentina, 1902
    Status
    Not applicable
    Location
    CER Instituto Medico /ID# 222193
    Quilmes, Buenos Aires, Argentina, 1878
    Status
    Not applicable
    Location
    Organizacion Medica de Investigacion (OMI) /ID# 222187
    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1015
    Status
    Not applicable
    Location
    CIER Centro de Investigaciones en Enfermedades Reumaticas /ID# 231769
    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1055
    Status
    Not applicable
    Location
    Instituto CAICI S.R.L /ID# 222191
    Rosario, Santa Fe Province, Argentina, 2000
    Status
    Not applicable
    Location
    CIMER Centro Integral de Medicina Respiratoria /ID# 222188
    San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    Status
    Not applicable
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