Inflammatory DiseaseLOOK-UPNCT06498167
Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)
An observational study of Inflammatory Disease and Drug Side Effect, run by Universidade do Porto at 3 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Disease, Drug Side Effect, Drug Use
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 3 sitesPortugal
- Study dates
- 1 Jul 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients exposed to upadacitinib (Rinvoq™).
Who may be able to join
- Prescription of Rinvoq™ from January 1, 2024;
- 18 years of age or older at the time of recruitment; and
- Expressed consent to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites, 1 recruiting
- Active, not recruiting
Unidade Local de Saúde de Santo António, E.P.E.
Porto, 4050-366
- Recruiting
Unidade Local de Saúde de São João, E.P.E.
Porto, 4200-319
Manuela Pinto, PharmD, +351225512143, manuela.milne@ulssjoao.min-saud.pt
Manuela Pinto, PharmD
- Active, not recruiting
Unidade Local de Saúde de Gaia/Espinho, E.P.E.
Porto, 4434-502
About this study
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.
Read the detailed description
The LOOK-UP study is an investigator-initiated clinical study conducted by INFARMED, the Portuguese Authority of Medicines and Health Products, I.P., and coordinated by the Porto Pharmacovigilance Centre at the Faculty of Medicine, University of Porto. The study aims to monitor the post-marketing safety of Rinvoq™ (upadacitinib), a medicine indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. Rinvoq™, a selective and reversible Janus Kinase (JAK) 1 inhibitor, has been under additional monitoring by the European Medicines Agency (EMA) since its approval in December 2019, necessitating active safety surveillance in real-world settings.
The primary objective of the LOOK-UP study is to quantify the incidence of adverse events in patients prescribed Rinvoq™, with a focus on serious adverse events such as malignant neoplasms, non-melanoma skin cancer, major adverse cardiovascular events, venous thromboembolism, serious and opportunistic infections, gastrointestinal perforations, liver injuries, bone fractures, and all-cause mortality. Secondary objectives include describing the incidence of adverse events among specific subgroups, such as very elderly patients, patients with moderate hepatic impairment, and patients with severe renal impairment. Additionally, the study aims to characterize patient-reported adverse events using MedDRA terms. An exploratory objective is to evaluate adherence to risk minimization measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) for the safe use of Rinvoq™.
The study is designed as a Phase 4 post-authorization safety study (PASS), utilizing an observational cohort approach that is both multicentric and ambispective. This design includes prospective and retrospective monitoring of patients, ensuring comprehensive safety analysis. The study will be conducted exclusively in hospital settings within the Porto district, reflecting the prescription and usage constraints of Rinvoq™.
- Conditions
- Inflammatory Disease, Drug Side Effect, Drug Use, Adverse Drug Event, Adverse Drug Reaction, Safety Issues
- Being tested
- Upadacitinib
- Keywords
- Upadacitinib, Rinvoq, Rheumatoid arthritis, Psoriatic arthritis, Axial spondyloarthritis, Atopic dermatitis, Ulcerative colitis, Crohn's disease, Pharmacovigilance risk, Drug safety monitoring, Patient Safety
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Arthritis, Rheumatoid, Arthritis, Psoriatic, Axial Spondyloarthritis, Dermatitis, Atopic, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Also called Rinvoq, ATC 200000041628
Exposure to upadacitinib (Rinvoq™) in its different formulations approved by the Portuguese regulatory authority (15, 30, or 45mg extended-release tablets).
| Study group | Role | What they receive |
|---|---|---|
| Upadatacinib Arm | Patients exposed to upadacitinib (Rinvoq™) Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Rate at which patients identified with risk factors are prescribed Rinvoq™ despite the availability of viable therapeutic alternatives. Patients considered to have risk factors include: (i) individuals aged 65 or older; (ii) current smokers or those with a long history of smoking; (iii) individuals at high risk of serious cardiovascular problems, such as heart attacks or strokes, or those more likely to develop cancer.
The outcome will be assessed through direct contact with clinical specialists (prescribers) to confirm the availability of therapeutic alternatives. A case is non-compliant if a patient with risk factors is prescribed Rinvoq™ despite an available alternative.
Measured: This outcome will be assessed at any time during the three-month monitoring period of each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., Unidade de Farmacovigilância do Porto, Unidade Local de Saúde São João, Oporto, Unidade Local de Saúde de Santo António, E.P.E., Unidade Local de Saude de Gaia e Espinho EPE, RISE Health
- Responsible party
- Sponsor
- Investigators
- Inês Ribeiro Vaz, PharmD, MPH, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498167
- Sponsor's protocol ID
- LookUp
- Other IDs
- EUPAS1000000227
- Acronym
- LOOK-UP
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)
- ClinicalTrials.gov ID
- NCT06498167
- Acronym / sponsor ID
- LOOK-UP / LookUp
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., Unidade de Farmacovigilância do Porto, Unidade Local de Saúde São João, Oporto, Unidade Local de Saúde de Santo António, E.P.E., Unidade Local de Saude de Gaia e Espinho EPE, RISE Health
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The LOOK-UP study is an investigator-initiated clinical study conducted by INFARMED, the Portuguese Authority of Medicines and Health Products, I.P., and coordinated by the Porto Pharmacovigilance Centre at the Faculty of Medicine, University of Porto. The study aims to monitor the post-marketing safety of Rinvoq™ (upadacitinib), a medicine indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. Rinvoq™, a selective and reversible Janus Kinase (JAK) 1 inhibitor, has been under additional monitoring by the European Medicines Agency (EMA) since its approval in December 2019, necessitating active safety surveillance in real-world settings.
The primary objective of the LOOK-UP study is to quantify the incidence of adverse events in patients prescribed Rinvoq™, with a focus on serious adverse events such as malignant neoplasms, non-melanoma skin cancer, major adverse cardiovascular events, venous thromboembolism, serious and opportunistic infections, gastrointestinal perforations, liver injuries, bone fractures, and all-cause mortality. Secondary objectives include describing the incidence of adverse events among specific subgroups, such as very elderly patients, patients with moderate hepatic impairment, and patients with severe renal impairment. Additionally, the study aims to characterize patient-reported adverse events using MedDRA terms. An exploratory objective is to evaluate adherence to risk minimization measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) for the safe use of Rinvoq™.
The study is designed as a Phase 4 post-authorization safety study (PASS), utilizing an observational cohort approach that is both multicentric and ambispective. This design includes prospective and retrospective monitoring of patients, ensuring comprehensive safety analysis. The study will be conducted exclusively in hospital settings within the Porto district, reflecting the prescription and usage constraints of Rinvoq™.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upadatacinib Arm | – | Drug: UpadacitinibPatients exposed to upadacitinib (Rinvoq™) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients exposed to upadacitinib (Rinvoq™).
Key inclusion criteria (3 listed)
- Prescription of Rinvoq™ from January 1, 2024;
- 18 years of age or older at the time of recruitment; and
- Expressed consent to participate in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibAlso: Rinvoq, ATC 200000041628Exposure to upadacitinib (Rinvoq™) in its different formulations approved by the Portuguese regulatory authority (15, 30, or 45mg extended-release tablets). | Drug | Upadatacinib Arm |
Primary outcome
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.
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.
1 secondary outcome
Rate of non-compliance with PRAC recommendations
Time frame: This outcome will be assessed at any time during the three-month monitoring period of each patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inês Ribeiro Vaz, PharmD, MPH, PhD principal investigator
Universidade do Porto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Disease and Drug Side Effect, run by Universidade do Porto at 3 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inês Ribeiro Vaz, PharmD, MPH, PhD (+ 351220426952, inesvaz@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.