A Study of the Real-life Management of Psoriasis Patients Treated With Otezla® (Apremilast) in Belgium

NCT03097003 | Completed

• 2 other identifiers: CC-10004-PSOR-016U1111-1194-1580
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 22

Brief Summary

OTELO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study. The study will include a representative sample of approximately 250 patients with moderate-to-severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label and reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after commencing the study treatment. As this study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice.

Conditions

Psoriasis

Keywords

Proriasis; Real-life management; Observational; Otezla; CC-10004; Apremilast; Belgium; OTELO

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Patient Benefit Index for skin diseases (standard version) (PBI-S) ≥ 1 at 6 months after apremilast initiation.

  The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.

  Up to 6 Months

Secondary Outcomes (15)

• Characteristics of the patients treated with apremilast

  Baseline

• Proportion of patients with PBI-S = 4 at 6 months after apremilast initiation

  Up to 6 Months

• PBI-S outcome score after apremilast initiation

  up to 18 months

• Proportion of patients having clear/no psoriasis based on Patient Global Assessment (PtGA) at 6 months after apremilast initiation

  up to 6 months

• Change from baseline in the PtGA after apremilast initiation

  up to 18 months

Study Arms (1)

Use of Apremilast in patient with plaque psoriasis

Psoriasis patients treated with Otezla® (Apremilast) in Belgium

Drug: Apremilast

Interventions

Apremilast DRUG

Psoriasis patients treated with Otezla® (Apremilast) in Belgium

Use of Apremilast in patient with plaque psoriasis

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

Adult patients with moderate-to-severe plaque psoriasis visiting dermatology practices in Belgium and eligible for treatment with apremilast according to the local label and reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after commencing the treatment with apremilast. 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 moderate-to-severe chronic plaque psoriasis. As per Belgian National Institute for Health and Disability Insurance (NIHDI), moderate-to-severe plaque psoriasis in adult patients is defined by a Body Surface Area (BSA) \> 10% or aPsoriasis Area and Severity Index (PASI) \> 10.
• For whom the treating dermatologist has made the decision to commence apremilast treatment in accordance with the local label and reimbursement criteria
• Able to follow the instructions of the study.
• Having signed an Informed Consent Form (ICF)

You may not qualify if:

• Patients who have received apremilast \> 4 weeks prior to the enrolment visit.
• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (22)

AZ Sint Jan

Bruges, 8000, Belgium

Location

CHU St Pierre

Brussels, 1000, Belgium

Location

CHU Brugmann (Victor Horta)

Brussels, 1020, Belgium

Location

Clin Univ de Bxl Hôpital Erasme

Brussels, 1070, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

Private Practice Geel

Geel, 2440, Belgium

Location

Private Practice Genk

Genk, 3600, Belgium

Location

AZ Sint Lucas

Ghent, 9000, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

CHU UCL Mont-Godinne

Godinne, 5530, Belgium

Location

Clinique André Renard d'Herstal

Herstal, 4040, Belgium

Location

Private Practice Lede

Lede, 9340, Belgium

Location

UZ Leuven Sint Rafael

Leuven, 3000, Belgium

Location

CHU Sart-Tilman

Liège, 4000, Belgium

Location

GHdC - site IMTR

Loverval, 6280, Belgium

Location

Dermatologie Maldegem

Malgegem, 9990, Belgium

Location

Private Practice Mons

Mons, 7000, Belgium

Location

Private Practice Namur

Namur, 5000, Belgium

Location

Ste Elisabeth - Namur

Namur, 5000, Belgium

Location

CH Bois Abbaye-Hesbaye

Seraing, 4100, Belgium

Location

Related Publications (1)

• Ghislain PD, Lambert J, Lam Hoai XL, Hillary T, Roquet-Gravy PP, de la Brassinne M, Segaert S. Real-Life Effectiveness of Apremilast for the Treatment of Psoriasis in Belgium: Results From the Observational OTELO Study. Adv Ther. 2022 Feb;39(2):1068-1080. doi: 10.1007/s12325-021-01981-7. Epub 2022 Jan 3.

  PMID: 34977985 DERIVED

Related Links

• Expanded Access for CC-10004

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

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 6, 2017
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

BE (22)