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)

April 14, 2020 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
273

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Subjects with Moderate to Severe Plaque Psoriasis
Subjects with Moderate to Severe Plaque Psoriasis in Greece

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: 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.
16 weeks post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving intermediate response
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
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
Time Frame: 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.
Up to 12 months
Time to the first missed dose during the study observation period
Time Frame: Up to 12 months
Patient diary will be reviewed to assess this information
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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