A Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece

Completed

• Conditions: Moderate to Severe Plaque Psoriasis

• Registration Number: NCT02713295
• Lead Sponsor: AbbVie

Brief Summary

This study estimates the treatment goal achievement rate, depicts the implementation of the Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and transitioning, and assesses patient adherence and persistence with adalimumab therapy in the routine clinical practice in Greece.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-18
• Study Start: 2016-06-16
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-19
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• Clinical diagnosis of plaque psoriasis for at least 6 months, and moderate to severe disease course at the time of adalimumab treatment onset, defined as Body Surface Area (BSA) >10 or PASI >10 and DLQI >10
• Patients for whom the decision to prescribe therapy with adalimumab (Humira®) according to the locally approved summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study
• Patients with an available Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores at the start of adalimumab treatment
• Patients able and willing to provide written informed consent and to comply with the requirements of this study protocol
• Patients with a signed informed consent document

Exclusion Criteria

• Patients should not have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular)
• Patients for whom treatment with adalimumab has been initiated more than 2 weeks prior to their enrolment into the study
• Patients that meet any of the contraindications to the administration of the study drug according to the latest version of the locally approved SmPC
• Patients who have previously been exposed to adalimumab unless a period of at least 6 months from the last dose has elapsed
• Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with adalimumab.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants who will achieve the European Consensus Programme (ECP)-defined treatment goals at the end of the induction phase (i.e. 16 weeks post-treatment onset)	16 weeks post-treatment	Achievement of the treatment goals during the induction phase is defined as: * Treatment Success: i.e. \>=75% Psoriasis Area Severity Index (PASI) score reduction OR; * Intermediate Response with Dermatology Life Quality Index (DLQI) \<=5: i.e. PASI score reduction \>=50% but \<75% with DLQI \<=5.

Secondary Outcome Measures

Name	Time	Method
Proportion of participant achieving treatment success	Up to 12 months	Treatment success rate is defined as participants with \>=75% PASI score reduction compared to week 0 (baseline).
Time to the first missed dose during the study observation period	Up to 12 months	Patient diary will be reviewed to assess this information
Proportion of participants achieving intermediate response	Up to 12 months	Intermediate response is defined as participants with PASI score reduction \>=50% but \<75% compared to week 0 (baseline).
Proportion of participant with treatment failure	Up to 12 months	Treatment failure is defined as participants with PASI score reduction \<50% compared to week 0 (baseline).
Proportion of participants achieving the treatment goals	Up to 12 months	According to the European Consensus Programme (ECP) guidelines, achievement of the treatment goals during the maintenance phase is defined as: * Treatment Success: i.e. \>=75% Psoriasis Area Severity Index (PASI) score reduction compared to the time of therapy initiation (i.e. baseline) (or); * Intermediate Response with Dermatology Life Quality Index (DLQI) \<=5: i.e. PASI score reduction \>=50% but \<75% compared to baseline, with DLQI \<=5.

Trial Locations

Locations (43)

PP of Ekaterini Galaterou /ID# 149713; 🇬🇷 Athens, AGIA Paraskeui, Greece

PP of Antonios Seretis /ID# 149714; 🇬🇷 Athens, Chalandri, Greece

PP of Maria Loukatou /ID# 149706; 🇬🇷 Athens, Glyfada, Greece

PP of Michael Kakepis /ID# 149693; 🇬🇷 Athens, Greece

PP of Markos Papakonstantis /ID# 149702; 🇬🇷 Athens, Greece

Genl Hospital Andreas Syggros /ID# 149516; 🇬🇷 Athens, Greece

PP of Stelios Charalampidis /ID# 149727; 🇬🇷 Thessaloniki, Greece

General Uni hosp of Larissa /ID# 151442; 🇬🇷 Larissa, Thessalia, Greece

PP of Konstantinos Tsaousis /ID# 149704; 🇬🇷 Amaliada, Greece

PP of Ioannis Papaggelopoulos /ID# 149703; 🇬🇷 Athens, Ampelokipi, Greece

PP of Eirini Stefanaki /ID# 149695; 🇬🇷 Athens, NEA Filadelfeia, Greece

PP of Panagiotis Deligiannis /ID# 149708; 🇬🇷 Athens, Greece

Kontargiris, MD, Kalamata, GR /ID# 151444; 🇬🇷 Kalamata, Greece

PP of Konstantinos Markakis /ID# 149723; 🇬🇷 Orestiada, Greece

PP of Theognosia Vergou /ID# 149694; 🇬🇷 Athens, VARI, Greece

Genl Hospital Andreas Syggros /ID# 149687; 🇬🇷 Athens, Greece

PP of Chrysa Zisimou Politopou /ID# 149728; 🇬🇷 Stylida, Greece

Tzaneio general hospital of Piraeus /ID# 149518; 🇬🇷 Piraeus, Attiki, Greece

PP of Georgios Papadopoulos /ID# 149712; 🇬🇷 Athens, Greece

Manousari, MD, Veroia, GR /ID# 151445; 🇬🇷 Veroia, Greece

PP of Prodromos Christoforidis /ID# 149730; 🇬🇷 Volos, Greece

General Hospital of Thessaloni /ID# 149692; 🇬🇷 Thessaloniki, Greece

PP of Maria Sifaki /ID# 149717; 🇬🇷 Arkalochori, Greece

General Uni hosp of Larissa /ID# 149688; 🇬🇷 Larissa, Thessalia, Greece

General Univ Hosp "Attikon" /ID# 149517; 🇬🇷 Athens, Attiki, Greece

PP of Despoina Arnaoutoglou /ID# 149707; 🇬🇷 Athens, Glyfada, Greece

PP of Pantelis Aronis /ID# 149705; 🇬🇷 Athens, NEA Smyrni, Greece

PP of Kalliopi Karamanolaki /ID# 149720; 🇬🇷 Crete, Heraklion, Greece

Konstantopouleio General Hospi /ID# 149690; 🇬🇷 Nea Ionia, Greece

PP of Ioannis Krikellis /ID# 149715; 🇬🇷 Athens, Greece

PP of Pantelis Souvantzidis /ID# 149726; 🇬🇷 Thessaloniki, Greece

Kallidis, MD, Thessaloniki, GR /ID# 151443; 🇬🇷 Thessaloniki, Greece

General Hospital of Thessaloniki George Papanikolaou /ID# 149515; 🇬🇷 Thessaloniki, Greece

Rigatos, MD, Patra, GR /ID# 151446; 🇬🇷 Patras, Greece

University Gen Hosp of Patra /ID# 149691; 🇬🇷 Patras, Greece

PP of Aimilios Lallas /ID# 149721; 🇬🇷 Thessaloniki, Greece

General Hospital of Xanthi /ID# 149519; 🇬🇷 Xanthi, Greece

PP of Stathis Gkourvelos /ID# 149709; 🇬🇷 Xilokastro, Greece

PP of Georgios Chaidemenos /ID# 149724; 🇬🇷 Thessaloniki, Greece

PP of Ioannis Mparkis /ID# 149711; 🇬🇷 Athens,neo Irakleio, Greece

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 158934; 🇬🇷 Athens, Greece

PP of Vasilios Chatzakis /ID# 149718; 🇬🇷 Crete, Heraklion, Greece

PP of Vasiliki Tzirka /ID# 149722; 🇬🇷 Drama, Greece