A Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium
APOLO
An Observational Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium
2 other identifiers
observational
106
1 country
22
Brief Summary
The study will include a representative sample of 150 patients with active Psoriatic Arthritis (PsA) for whom the treating rheumatologist has decided to begin treatment with apremilast. This study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating rheumatologist, in accordance with the local label and daily clinical practice. APOLO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2017
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2017
CompletedFirst Posted
Study publicly available on registry
March 31, 2017
CompletedStudy Start
First participant enrolled
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2018
CompletedApril 29, 2020
April 1, 2020
1.7 years
March 24, 2017
April 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients showing response assessed by improvement for at least 2 out of 4 measures which compose the Psoriatic Arthritis Response Criteria (PsARC) at 6 months after apremilast initiation with respect to baseline
The PsARC tool is a composite response measure that has been specifically developed to assess response to treatment in Psoriatic Arthritis (PsA). PsARC is considered as an acceptable primary endpoint by the European Medicines Agency (EMA) The response for a given subject is defined by an improvement for at least 2 out of 4 measures which compose the PsARC (Patient Global Assessment \[PtGA\] of disease activity, Patient Global Assessment \[PGA\] of disease activity, 68-joint count for pain/tenderness and 66 joint count for swelling) and no worsening in any of the 4 measures.
6 months after Apremilast initiation
Secondary Outcomes (12)
Characteristics of the patients treated with apremilast
Baseline
Change from baseline in measures which compose the PsARC (PtGA of disease activity, PGA of disease activity, 68-joint count for pain/tenderness, and 66-joint count for swelling)
up to 18 months
Change from Baseline in Psoriatic Arthritis Impact Of Disease 12 [PsAID12] score
up to 18 months
Change from Baseline in Health Assessment Questionnaire Disability Index [HAQ-DI] score
up to 18 months
Change from Baseline in disease activity Numerical Rating Scale (NRS)
up to 18 months
- +7 more secondary outcomes
Study Arms (1)
Use of apremilast in patients with active PsA
Psoriatic arthritis patients treated with Otezla® (apremilast) in Belgium
Interventions
Psoriatic arthritis patients treated with Otezla® (apremilast) in Belgium
Eligibility Criteria
Adult patients with active PsA visiting rheumatology practices in Belgium and eligible for treatment with apremilast according to the local label and reimbursement criteria. The decision to treat the patient with apremilast will be made prior to the decision to enter the patient into the study.
You may qualify if:
- \- Patients who meet ALL the following criteria can be enrolled:
- Male or female aged at least 18 years,
- With a diagnosis of active Psoriatic Arthritis (PsA),
- For whom the treating physician has made the decision to commence apremilast treatment in accordance with the local label and reimbursement criteria (refer to the reimbursement conditions mentioned in Section 1.2),
- Able to follow the instructions of the study,
- Having signed an Informed Consent Form (ICF).
You may not qualify if:
- Women who are pregnant, breastfeeding or planning on becoming pregnant,
- Non-menopausal women who are not using an adequate contraception method,
- Patients with hypersensitivity to apremilast or to one of its excipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (22)
ASZ Aalst
Aalst, 9300, Belgium
Onze Lieve Vrouw Aalst
Aalst, 9300, Belgium
AZ Sint-Jan
Bruges, 8000, Belgium
CHU St Pierre (César de Paepe)
Brussels, 1000, Belgium
Clinicque Saint-Jean Botanique
Brussels, 1000, Belgium
CHU Brugmann
Brussels, 1020, Belgium
Clin Univ de Bxl Hôpital Erasme
Brussels, 1170, Belgium
Cliniques Universiatires Saint-Luc
Brussels, 1200, Belgium
Private Practice
Céroux-Mousty, 1341, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
Reumacentrum Genk
Genk, 3600, Belgium
Reumaclinic
Genk, 3600, Belgium
UZ Gent
Ghent, 9000, Belgium
GHdC Site Saint-Joseph
Gilly, 6060, Belgium
CHU UCL Mont-Godinne
Godinne, 5530, Belgium
Reuma Instituut
Hasselt, 3500, Belgium
AZ Zeno campus Knokke-Heist
Knokke-Heist, 8300, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Reumatologie Medizorg
Merksem, 2170, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
Private Practice
Uccle, 1180, Belgium
Related Publications (1)
de Vlam K, Toukap AN, Kaiser MJ, Vanhoof J, Remans P, Van den Berghe M, Di Romana S, Van den Bosch F, Lories R. Real-World Efficacy and Safety of Apremilast in Belgian Patients with Psoriatic Arthritis: Results from the Prospective Observational APOLO Study. Adv Ther. 2022 Feb;39(2):1055-1067. doi: 10.1007/s12325-021-02016-x. Epub 2022 Jan 3.
PMID: 34977986DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2017
First Posted
March 31, 2017
Study Start
April 21, 2017
Primary Completion
December 27, 2018
Study Completion
December 27, 2018
Last Updated
April 29, 2020
Record last verified: 2020-04