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

NCT02713295 | Completed

• 1 other identifier: P15-693
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 43

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.

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Moderate Plaque Psoriasis; Severe Plaque Psoriasis; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of participants achieving intermediate response

  Up to 12 months

• Proportion of participant achieving treatment success

  Up to 12 months

• Proportion of participant with treatment failure

  Up to 12 months

• Proportion of participants achieving the treatment goals

  Up to 12 months

• Time to the first missed dose during the study observation period

  Up to 12 months

Study Arms (1)

Subjects with Moderate to Severe Plaque Psoriasis

Subjects with Moderate to Severe Plaque Psoriasis in Greece

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with Moderate to Severe Plaque Psoriasis in Greece

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (43)

General Univ Hosp "Attikon" /ID# 149517

Athens, Attica, 12562, Greece

Location

Tzaneio general hospital of Piraeus /ID# 149518

Piraeus, Attica, 18536, Greece

Location

General Uni hosp of Larissa /ID# 149688

Larissa, Thessaly, 415 00, Greece

Location

General Uni hosp of Larissa /ID# 151442

Larissa, Thessaly, 415 00, Greece

Location

PP of Konstantinos Tsaousis /ID# 149704

Amaliáda, 27200, Greece

Location

PP of Maria Sifaki /ID# 149717

Arkalochóri, 70300, Greece

Location

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 158934

Athens, 10676, Greece

Location

PP of Michael Kakepis /ID# 149693

Athens, 10682, Greece

Location

PP of Georgios Papadopoulos /ID# 149712

Athens, 11251, Greece

Location

PP of Ioannis Krikellis /ID# 149715

Athens, 11525, Greece

Location

PP of Markos Papakonstantis /ID# 149702

Athens, 11526, Greece

Location

PP of Panagiotis Deligiannis /ID# 149708

Athens, 11634, Greece

Location

Genl Hospital Andreas Syggros /ID# 149516

Athens, 16121, Greece

Location

Genl Hospital Andreas Syggros /ID# 149687

Athens, 16121, Greece

Location

PP of Ekaterini Galaterou /ID# 149713

Athens, AGIA Paraskeui, 15343, Greece

Location

PP of Ioannis Papaggelopoulos /ID# 149703

Athens, Ampelokipi, 11626, Greece

Location

PP of Antonios Seretis /ID# 149714

Athens, Chalandri, 15231, Greece

Location

PP of Despoina Arnaoutoglou /ID# 149707

Athens, Glyfada, 16562, Greece

Location

PP of Maria Loukatou /ID# 149706

Athens, Glyfada, 16675, Greece

Location

PP of Eirini Stefanaki /ID# 149695

Athens, NEA Filadelfeia, 14341, Greece

Location

PP of Pantelis Aronis /ID# 149705

Athens, NEA Smyrni, 17124, Greece

Location

PP of Theognosia Vergou /ID# 149694

Athens, VARI, 16672, Greece

Location

PP of Ioannis Mparkis /ID# 149711

Athens,neo Irakleio, 14121, Greece

Location

PP of Vasilios Chatzakis /ID# 149718

Crete, Heraklion, 71201, Greece

Location

PP of Kalliopi Karamanolaki /ID# 149720

Crete, Heraklion, 71305, Greece

Location

PP of Vasiliki Tzirka /ID# 149722

Drama, 66100, Greece

Location

Kontargiris, MD, Kalamata, GR /ID# 151444

Kalamata, 24100, Greece

Location

Konstantopouleio General Hospi /ID# 149690

Nea Ionia, 14233, Greece

Location

PP of Konstantinos Markakis /ID# 149723

Orestiáda, 68200, Greece

Location

Rigatos, MD, Patra, GR /ID# 151446

Pátrai, 26221, Greece

Location

University Gen Hosp of Patra /ID# 149691

Pátrai, 26504, Greece

Location

PP of Chrysa Zisimou Politopou /ID# 149728

Stilís, 35300, Greece

Location

PP of Aimilios Lallas /ID# 149721

Thessaloniki, 54623, Greece

Location

PP of Pantelis Souvantzidis /ID# 149726

Thessaloniki, 54623, Greece

Location

PP of Stelios Charalampidis /ID# 149727

Thessaloniki, 54623, Greece

Location

PP of Georgios Chaidemenos /ID# 149724

Thessaloniki, 54643, Greece

Location

General Hospital of Thessaloni /ID# 149692

Thessaloniki, 55134, Greece

Location

Kallidis, MD, Thessaloniki, GR /ID# 151443

Thessaloniki, 55236, Greece

Location

General Hospital of Thessaloniki George Papanikolaou /ID# 149515

Thessaloniki, 57010, Greece

Location

Manousari, MD, Veroia, GR /ID# 151445

Véroia, 59132, Greece

Location

PP of Prodromos Christoforidis /ID# 149730

Volos, 38221, Greece

Location

General Hospital of Xanthi /ID# 149519

Xánthi, 67100, Greece

Location

PP of Stathis Gkourvelos /ID# 149709

Xilokastro, 20400, Greece

Location

Related Links

• clinical study report synopsis

Study Officials

• AbbVie Inc.

  AbbVie

  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 15, 2016
• First Posted: March 18, 2016
• Study Start: June 16, 2016
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

GR (43)