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Study Complete
Sponsor ID
CC-10004-PSA-010

A study of the real-life management of psoriatic arthritis patients treated with Otezla® (apremilast) in BelgiumAPOLO

Sponsor ID
CC-10004-PSA-010
Clinicaltrials.gov ID
NCT03096990
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
N/A
Type
Observational
Masking
N/A
Enrollment
106
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 6 months after Apremilast initiation

Secondary Outcome Measures

Characteristics of the patients treated with apremilast

Timeframe: 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)

Timeframe: up to 18 months

Change from Baseline in Psoriatic Arthritis Impact Of Disease 12 [PsAID12] score

Timeframe: up to 18 months

Change from Baseline in Health Assessment Questionnaire Disability Index [HAQ-DI] score

Timeframe: up to 18 months

Change from Baseline in disease activity Numerical Rating Scale (NRS)

Timeframe: up to 18 months

Change from Baseline in pain/itch Visual Analogue Scale [VAS]

Timeframe: up to 18 months

Change from Baseline in body surface area (BSA)

Timeframe: up to 18 months

Change from Baseline in Leeds Enthesitis Index (LEI)

Timeframe: up to 18 months

Change from Baseline in Dactylitis score

Timeframe: up to 18 months

Mean duration of treatment with apremilast in biologic-naïve patients and in patients having received a previous biological treatment.

Timeframe: up to 18 months

Rate and reasons for discontinuation of apremilast treatment within 6 months after initiation

Timeframe: Up to 6 months

Adverse Events (AEs)

Timeframe: up to 18 months

Locations

Location
Status
Contact Us
Location
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Status
Recruiting
Location
CHU UCL Mont-Godinne
Godinne, Belgium, 5530
Status
Recruiting
Location
UZ Antwerpen
Edegem, Belgium, 2650
Status
Not yet recruiting
Location
CHU St Pierre (César de Paepe)
Bruxelles, Belgium, 1000
Status
Recruiting
Location
ASZ Aalst
Aalst, Belgium, 9300
Status
Recruiting
Location
CHU Sart-Tilman
Liège, Belgium, 4000
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Psoriatic Arthritis
    • Sex
    All
    Trial Dates
    Apr 2017 - Dec 2018
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - 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).
    Exclusion Criteria:
    - Patients who meet AT LEAST one of the following exclusion criteria will be excluded: • 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.