Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

Sponsor
Universidade do Porto
Study ID
NCT06498167
Status
Unknown

Conditions

  • Adverse Drug Event
  • Adverse Drug Reaction
  • Drug Side Effect
  • Drug Use
  • Inflammatory Disease
  • Safety Issues

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Exposure to upadacitinib (Rinvoq™) in its different formulations approved by the Portuguese regulatory authority (15, 30, or 45mg extended-release tablets).

Study Details

The LOOK-UP is an investigator-initiated clinical study with the aim of monitoring the post-marketing safety of the medicine Rinvoq™ (upadacitinib), which is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. The Marketing Authorisation Holder is AbbVie Deutschland GmbH \& Co. KG.

Key Dates

First listed
Jul 12, 2024
Start date
Jul 1, 2024
Status verified
Jul 2024
Primary completion
Oct 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Upadatacinib Arm
    Patients exposed to upadacitinib (Rinvoq™)

Primary Outcome Measure

Incidence of adverse events [ Time Frame: For the prospective cohort, the follow-up includes contacts at baseline (t=0), 2 weeks (t=1), 1 month (t=2), 2 months (t=3), and 3 months (t=4) after starting treatment. ]

Central Contacts

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