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

Moderate to Severe Plaque Psoriasis Clinical Trial

— CONCORDIA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713295
• Other study ID #: P15-693
• Status: Completed
• Start date: June 16, 2016
• Est. completion date: April 19, 2019

Study information

• Verified date: April 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Locations

Country	Name	City	State
Greece	PP of Konstantinos Tsaousis /ID# 149704	Amaliada
Greece	PP of Maria Sifaki /ID# 149717	Arkalochori
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 158934	Athens
Greece	General Univ Hosp "Attikon" /ID# 149517	Athens	Attiki
Greece	Genl Hospital Andreas Syggros /ID# 149516	Athens
Greece	Genl Hospital Andreas Syggros /ID# 149687	Athens
Greece	PP of Georgios Papadopoulos /ID# 149712	Athens
Greece	PP of Ioannis Krikellis /ID# 149715	Athens
Greece	PP of Markos Papakonstantis /ID# 149702	Athens
Greece	PP of Michael Kakepis /ID# 149693	Athens
Greece	PP of Panagiotis Deligiannis /ID# 149708	Athens
Greece	PP of Ekaterini Galaterou /ID# 149713	Athens, AGIA Paraskeui
Greece	PP of Ioannis Papaggelopoulos /ID# 149703	Athens, Ampelokipi
Greece	PP of Antonios Seretis /ID# 149714	Athens, Chalandri
Greece	PP of Despoina Arnaoutoglou /ID# 149707	Athens, Glyfada
Greece	PP of Maria Loukatou /ID# 149706	Athens, Glyfada
Greece	PP of Eirini Stefanaki /ID# 149695	Athens, NEA Filadelfeia
Greece	PP of Pantelis Aronis /ID# 149705	Athens, NEA Smyrni
Greece	PP of Theognosia Vergou /ID# 149694	Athens, VARI
Greece	PP of Ioannis Mparkis /ID# 149711	Athens,neo Irakleio
Greece	PP of Kalliopi Karamanolaki /ID# 149720	Crete, Heraklion
Greece	PP of Vasilios Chatzakis /ID# 149718	Crete, Heraklion
Greece	PP of Vasiliki Tzirka /ID# 149722	Drama
Greece	Kontargiris, MD, Kalamata, GR /ID# 151444	Kalamata
Greece	General Uni hosp of Larissa /ID# 149688	Larissa	Thessalia
Greece	General Uni hosp of Larissa /ID# 151442	Larissa	Thessalia
Greece	Konstantopouleio General Hospi /ID# 149690	Nea Ionia
Greece	PP of Konstantinos Markakis /ID# 149723	Orestiada
Greece	Rigatos, MD, Patra, GR /ID# 151446	Patras
Greece	University Gen Hosp of Patra /ID# 149691	Patras
Greece	Tzaneio general hospital of Piraeus /ID# 149518	Piraeus	Attiki
Greece	PP of Chrysa Zisimou Politopou /ID# 149728	Stylida
Greece	General Hospital of Thessaloni /ID# 149692	Thessaloniki
Greece	General Hospital of Thessaloniki George Papanikolaou /ID# 149515	Thessaloniki
Greece	Kallidis, MD, Thessaloniki, GR /ID# 151443	Thessaloniki
Greece	PP of Aimilios Lallas /ID# 149721	Thessaloniki
Greece	PP of Georgios Chaidemenos /ID# 149724	Thessaloniki
Greece	PP of Pantelis Souvantzidis /ID# 149726	Thessaloniki
Greece	PP of Stelios Charalampidis /ID# 149727	Thessaloniki
Greece	Manousari, MD, Veroia, GR /ID# 151445	Veroia
Greece	PP of Prodromos Christoforidis /ID# 149730	Volos
Greece	General Hospital of Xanthi /ID# 149519	Xanthi
Greece	PP of Stathis Gkourvelos /ID# 149709	Xilokastro

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	16 weeks post-treatment
Secondary	Proportion of participants achieving intermediate response	Intermediate response is defined as participants with PASI score reduction >=50% but <75% compared to week 0 (baseline).	Up to 12 months
Secondary	Proportion of participant achieving treatment success	Treatment success rate is defined as participants with >=75% PASI score reduction compared to week 0 (baseline).	Up to 12 months
Secondary	Proportion of participant with treatment failure	Treatment failure is defined as participants with PASI score reduction <50% compared to week 0 (baseline).	Up to 12 months
Secondary	Proportion of participants achieving the treatment goals	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.	Up to 12 months
Secondary	Time to the first missed dose during the study observation period	Patient diary will be reviewed to assess this information	Up to 12 months

External Links

•   clinical study report synopsis