Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

NCT06498167 | Recruiting DMC FDA Drug

• 2 other identifiers: LookUpEUPAS1000000227
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Upadacitinib; Rinvoq; Rheumatoid arthritis; Psoriatic arthritis; Axial spondyloarthritis; Atopic dermatitis; Ulcerative colitis; Crohn's disease; Pharmacovigilance risk; Drug safety monitoring; Patient Safety

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Incidence of adverse events occurring during the established follow-up period, coded according to MedDRA terminology. The outcome will be assessed through an ad-hoc questionnaire. The occurrence of adverse events will be queried in an open-ended, non-directed manner. Patients will be encouraged to report any undesired events they experience during the treatment, without being limited to predefined specific adverse events.

  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.

Secondary Outcomes (1)

• Rate of non-compliance with PRAC recommendations

  This outcome will be assessed at any time during the three-month monitoring period of each patient.

Study Arms (1)

Upadatacinib Arm

Patients exposed to upadacitinib (Rinvoq™)

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

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

Also known as: Rinvoq, ATC 200000041628

Upadatacinib Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients exposed to upadacitinib (Rinvoq™).

You may qualify if:

• Prescription of Rinvoq™ from January 1, 2024;
• years of age or older at the time of recruitment; and
• Expressed consent to participate in the study.

You may not qualify if:

• They have any degree of cognitive impairment that prevents them from responding to a questionnaire administered by telephone;
• They are participating in a phase I, II, or III clinical trial;
• They have a life expectancy of less than 1 month; or
• They do not have a valid telephone contact.

Sponsors & Collaborators

• Universidade do Porto: lead
• INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.: collaborator
• Unidade de Farmacovigilância do Porto: collaborator
• Unidade Local de Saúde São João: collaborator
• Unidade Local de Saúde de Santo António, E.P.E.: collaborator
• Unidade Local de Saude de Gaia e Espinho EPE: collaborator
• RISE Health: collaborator

Study Sites (3)

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

Porto, 4050-366, Portugal

ACTIVE NOT RECRUITING

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

Porto, 4200-319, Portugal

RECRUITING

Unidade Local de Saúde de Gaia/Espinho, E.P.E.

Porto, 4434-502, Portugal

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Arthritis, Rheumatoid; Arthritis, Psoriatic; Axial Spondyloarthritis; Dermatitis, Atopic; Colitis, Ulcerative; Crohn Disease

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Ankylosis; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Inês Ribeiro Vaz, PharmD, MPH, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inês Ribeiro Vaz, PharmD, MPH, PhD

CONTACT

+ 351220426952; inesvaz@med.up.pt

Renato Ferreira da Silva, PharmD

CONTACT

+351220426913; rsilva@med.up.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

PT (3)