Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

Sponsor
Universidade do Porto
Study ID
NCT06498167
Status
Recruiting
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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

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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