Clinical trial NCT02713295: 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
Official title: A Non-interventional Prospective Cohort 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: Moderate Plaque Psoriasis
Severe Plaque Psoriasis
Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Moderate to Severe Plaque Psoriasis in Greece

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 16 weeks post-treatment
Secondary outcomes:
measure: Proportion of participants achieving intermediate response
timeFrame: Up to 12 months
measure: Proportion of participant achieving treatment success
timeFrame: Up to 12 months
measure: Proportion of participant with treatment failure
timeFrame: Up to 12 months
measure: Proportion of participants achieving the treatment goals
timeFrame: Up to 12 months
measure: Time to the first missed dose during the study observation period
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: General Univ Hosp "Attikon" /ID# 149517
state: Attiki
city: Piraeus
country: Greece
facility: Tzaneio general hospital of Piraeus /ID# 149518
state: Attiki
city: Larissa
country: Greece
facility: General Uni hosp of Larissa /ID# 149688
state: Thessalia
city: Larissa
country: Greece
facility: General Uni hosp of Larissa /ID# 151442
state: Thessalia
city: Amaliada
country: Greece
facility: PP of Konstantinos Tsaousis /ID# 149704
city: Arkalochori
country: Greece
facility: PP of Maria Sifaki /ID# 149717
city: Athens, AGIA Paraskeui
country: Greece
facility: PP of Ekaterini Galaterou /ID# 149713
city: Athens, Ampelokipi
country: Greece
facility: PP of Ioannis Papaggelopoulos /ID# 149703
city: Athens, Chalandri
country: Greece
facility: PP of Antonios Seretis /ID# 149714
city: Athens, Glyfada
country: Greece
facility: PP of Despoina Arnaoutoglou /ID# 149707
city: Athens, Glyfada
country: Greece
facility: PP of Maria Loukatou /ID# 149706
city: Athens, NEA Filadelfeia
country: Greece
facility: PP of Eirini Stefanaki /ID# 149695
city: Athens, NEA Smyrni
country: Greece
facility: PP of Pantelis Aronis /ID# 149705
city: Athens, VARI
country: Greece
facility: PP of Theognosia Vergou /ID# 149694
city: Athens,neo Irakleio
country: Greece
facility: PP of Ioannis Mparkis /ID# 149711
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 158934
city: Athens
country: Greece
facility: PP of Michael Kakepis /ID# 149693
city: Athens
country: Greece
facility: PP of Georgios Papadopoulos /ID# 149712
city: Athens
country: Greece
facility: PP of Ioannis Krikellis /ID# 149715
city: Athens
country: Greece
facility: PP of Markos Papakonstantis /ID# 149702
city: Athens
country: Greece
facility: PP of Panagiotis Deligiannis /ID# 149708
city: Athens
country: Greece
facility: Genl Hospital Andreas Syggros /ID# 149516
city: Athens
country: Greece
facility: Genl Hospital Andreas Syggros /ID# 149687
city: Crete, Heraklion
country: Greece
facility: PP of Vasilios Chatzakis /ID# 149718
city: Crete, Heraklion
country: Greece
facility: PP of Kalliopi Karamanolaki /ID# 149720
city: Drama
country: Greece
facility: PP of Vasiliki Tzirka /ID# 149722
city: Kalamata
country: Greece
facility: Kontargiris, MD, Kalamata, GR /ID# 151444
city: Nea Ionia
country: Greece
facility: Konstantopouleio General Hospi /ID# 149690
city: Orestiada
country: Greece
facility: PP of Konstantinos Markakis /ID# 149723
city: Patras
country: Greece
facility: Rigatos, MD, Patra, GR /ID# 151446
city: Patras
country: Greece
facility: University Gen Hosp of Patra /ID# 149691
city: Stylida
country: Greece
facility: PP of Chrysa Zisimou Politopou /ID# 149728
city: Thessaloniki
country: Greece
facility: PP of Aimilios Lallas /ID# 149721
city: Thessaloniki
country: Greece
facility: PP of Pantelis Souvantzidis /ID# 149726
city: Thessaloniki
country: Greece
facility: PP of Stelios Charalampidis /ID# 149727
city: Thessaloniki
country: Greece
facility: PP of Georgios Chaidemenos /ID# 149724
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloni /ID# 149692
city: Thessaloniki
country: Greece
facility: Kallidis, MD, Thessaloniki, GR /ID# 151443
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki George Papanikolaou /ID# 149515
city: Veroia
country: Greece
facility: Manousari, MD, Veroia, GR /ID# 151445
city: Volos
country: Greece
facility: PP of Prodromos Christoforidis /ID# 149730
city: Xanthi
country: Greece
facility: General Hospital of Xanthi /ID# 149519
city: Xilokastro
country: Greece
facility: PP of Stathis Gkourvelos /ID# 149709
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: