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 (CONCORDIA)

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

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.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Plaque Psoriasis

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• Greece
  • Amaliada, Greece, 27200
    • PP of Konstantinos Tsaousis /ID# 149704
  • Arkalochori, Greece, 70300
    • PP of Maria Sifaki /ID# 149717
  • Athens, Greece, 10676
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 158934
  • Athens, Greece, 10682
    • PP of Michael Kakepis /ID# 149693
  • Athens, Greece, 11251
    • PP of Georgios Papadopoulos /ID# 149712
  • Athens, Greece, 11525
    • PP of Ioannis Krikellis /ID# 149715
  • Athens, Greece, 11526
    • PP of Markos Papakonstantis /ID# 149702
  • Athens, Greece, 11634
    • PP of Panagiotis Deligiannis /ID# 149708
  • Athens, Greece, 16121
    • Genl Hospital Andreas Syggros /ID# 149516
  • Athens, Greece, 16121
    • Genl Hospital Andreas Syggros /ID# 149687
  • Athens, AGIA Paraskeui, Greece, 15343
    • PP of Ekaterini Galaterou /ID# 149713
  • Athens, Ampelokipi, Greece, 11626
    • PP of Ioannis Papaggelopoulos /ID# 149703
  • Athens, Chalandri, Greece, 15231
    • PP of Antonios Seretis /ID# 149714
  • Athens, Glyfada, Greece, 16562
    • PP of Despoina Arnaoutoglou /ID# 149707
  • Athens, Glyfada, Greece, 16675
    • PP of Maria Loukatou /ID# 149706
  • Athens, NEA Filadelfeia, Greece, 14341
    • PP of Eirini Stefanaki /ID# 149695
  • Athens, NEA Smyrni, Greece, 17124
    • PP of Pantelis Aronis /ID# 149705
  • Athens, VARI, Greece, 16672
    • PP of Theognosia Vergou /ID# 149694
  • Athens,neo Irakleio, Greece, 14121
    • PP of Ioannis Mparkis /ID# 149711
  • Crete, Heraklion, Greece, 71201
    • PP of Vasilios Chatzakis /ID# 149718
  • Crete, Heraklion, Greece, 71305
    • PP of Kalliopi Karamanolaki /ID# 149720
  • Drama, Greece, 66100
    • PP of Vasiliki Tzirka /ID# 149722
  • Kalamata, Greece, 24100
    • Kontargiris, MD, Kalamata, GR /ID# 151444
  • Nea Ionia, Greece, 14233
    • Konstantopouleio General Hospi /ID# 149690
  • Orestiada, Greece, 68200
    • PP of Konstantinos Markakis /ID# 149723
  • Patras, Greece, 26221
    • Rigatos, MD, Patra, GR /ID# 151446
  • Patras, Greece, 26504
    • University Gen Hosp of Patra /ID# 149691
  • Stylida, Greece, 35300
    • PP of Chrysa Zisimou Politopou /ID# 149728
  • Thessaloniki, Greece, 54623
    • PP of Aimilios Lallas /ID# 149721
  • Thessaloniki, Greece, 54623
    • PP of Pantelis Souvantzidis /ID# 149726
  • Thessaloniki, Greece, 54623
    • PP of Stelios Charalampidis /ID# 149727
  • Thessaloniki, Greece, 54643
    • PP of Georgios Chaidemenos /ID# 149724
  • Thessaloniki, Greece, 55134
    • General Hospital of Thessaloni /ID# 149692
  • Thessaloniki, Greece, 55236
    • Kallidis, MD, Thessaloniki, GR /ID# 151443
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki George Papanikolaou /ID# 149515
  • Veroia, Greece, 59132
    • Manousari, MD, Veroia, GR /ID# 151445
  • Volos, Greece, 38221
    • PP of Prodromos Christoforidis /ID# 149730
  • Xanthi, Greece, 67100
    • General Hospital of Xanthi /ID# 149519
  • Xilokastro, Greece, 20400
    • PP of Stathis Gkourvelos /ID# 149709
  • Attiki
    • Athens, Attiki, Greece, 12562
      • General Univ Hosp "Attikon" /ID# 149517
    • Piraeus, Attiki, Greece, 18536
      • Tzaneio general hospital of Piraeus /ID# 149518
  • Thessalia
    • Larissa, Thessalia, Greece, 415 00
      • General Uni hosp of Larissa /ID# 149688
    • Larissa, Thessalia, Greece, 415 00
      • General Uni hosp of Larissa /ID# 151442

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with Moderate to Severe Plaque Psoriasis in Greece

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects with Moderate to Severe Plaque Psoriasis; Subjects with Moderate to Severe Plaque Psoriasis in Greece

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Time to the first missed dose during the study observation period	Patient diary will be reviewed to assess this information	Up to 12 months

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2016
• Primary Completion (Actual): April 19, 2019
• Study Completion (Actual): April 19, 2019

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Plaque Psoriasis; Moderate Plaque Psoriasis; Severe Plaque Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: P15-693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No