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Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

NCT06498167 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-07-15

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Upadacitinib

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

Sponsors & Collaborators

  • INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.

    collaborator UNKNOWN

  • Unidade de Farmacovigilância do Porto

    collaborator UNKNOWN

  • Unidade Local de Saúde de São João, E.P.E.

    collaborator UNKNOWN

  • Unidade Local de Saúde de Santo António, E.P.E.

    collaborator UNKNOWN

  • Unidade Local de Saude de Gaia e Espinho EPE

    collaborator OTHER

  • RISE Health

    collaborator UNKNOWN

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Inês Ribeiro Vaz, PharmD, MPH, PhD · Universidade do Porto

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-10-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06498167 on ClinicalTrials.gov