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Moderate to Severe Plaque PsoriasisCONCORDIANCT02713295

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

An observational study of Moderate to Severe Plaque Psoriasis, run by AbbVie at 43 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Moderate to Severe Plaque Psoriasis
How many people
273 participants
Where
43 sitesGreece
Study dates
16 Jun 2016to 19 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects with Moderate to Severe Plaque Psoriasis in Greece

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Greece43 sites

  • PP of Konstantinos Tsaousis /ID# 149704

    Amaliáda, 27200

  • PP of Maria Sifaki /ID# 149717

    Arkalochóri, 70300

  • General Univ Hosp "Attikon" /ID# 149517

    Athens, Attica, 12562

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

    Athens, 10676

  • PP of Michael Kakepis /ID# 149693

    Athens, 10682

  • PP of Georgios Papadopoulos /ID# 149712

    Athens, 11251

  • PP of Ioannis Krikellis /ID# 149715

    Athens, 11525

  • PP of Markos Papakonstantis /ID# 149702

    Athens, 11526

  • PP of Panagiotis Deligiannis /ID# 149708

    Athens, 11634

  • Genl Hospital Andreas Syggros /ID# 149516

    Athens, 16121

  • Genl Hospital Andreas Syggros /ID# 149687

    Athens, 16121

  • PP of Ekaterini Galaterou /ID# 149713

    Athens, AGIA Paraskeui, 15343

  • PP of Ioannis Papaggelopoulos /ID# 149703

    Athens, Ampelokipi, 11626

  • PP of Antonios Seretis /ID# 149714

    Athens, Chalandri, 15231

  • PP of Despoina Arnaoutoglou /ID# 149707

    Athens, Glyfada, 16562

  • PP of Maria Loukatou /ID# 149706

    Athens, Glyfada, 16675

  • PP of Eirini Stefanaki /ID# 149695

    Athens, NEA Filadelfeia, 14341

  • PP of Pantelis Aronis /ID# 149705

    Athens, NEA Smyrni, 17124

  • PP of Theognosia Vergou /ID# 149694

    Athens, VARI, 16672

  • PP of Ioannis Mparkis /ID# 149711

    Athens,neo Irakleio, 14121

  • PP of Vasilios Chatzakis /ID# 149718

    Crete, Heraklion, 71201

  • PP of Kalliopi Karamanolaki /ID# 149720

    Crete, Heraklion, 71305

  • PP of Vasiliki Tzirka /ID# 149722

    Drama, 66100

  • Kontargiris, MD, Kalamata, GR /ID# 151444

    Kalamata, 24100

  • General Uni hosp of Larissa /ID# 149688

    Larissa, Thessaly, 415 00

  • General Uni hosp of Larissa /ID# 151442

    Larissa, Thessaly, 415 00

  • Konstantopouleio General Hospi /ID# 149690

    Nea Ionia, 14233

  • PP of Konstantinos Markakis /ID# 149723

    Orestiáda, 68200

  • Rigatos, MD, Patra, GR /ID# 151446

    Pátrai, 26221

  • University Gen Hosp of Patra /ID# 149691

    Pátrai, 26504

  • Tzaneio general hospital of Piraeus /ID# 149518

    Piraeus, Attica, 18536

  • PP of Chrysa Zisimou Politopou /ID# 149728

    Stilís, 35300

  • PP of Aimilios Lallas /ID# 149721

    Thessaloniki, 54623

  • PP of Pantelis Souvantzidis /ID# 149726

    Thessaloniki, 54623

  • PP of Stelios Charalampidis /ID# 149727

    Thessaloniki, 54623

  • PP of Georgios Chaidemenos /ID# 149724

    Thessaloniki, 54643

  • General Hospital of Thessaloni /ID# 149692

    Thessaloniki, 55134

  • Kallidis, MD, Thessaloniki, GR /ID# 151443

    Thessaloniki, 55236

  • General Hospital of Thessaloniki George Papanikolaou /ID# 149515

    Thessaloniki, 57010

  • Manousari, MD, Veroia, GR /ID# 151445

    Véroia, 59132

  • PP of Prodromos Christoforidis /ID# 149730

    Volos, 38221

  • General Hospital of Xanthi /ID# 149519

    Xánthi, 67100

  • PP of Stathis Gkourvelos /ID# 149709

    Xilokastro, 20400

Other trials in Greece

About this study

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

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.

Keywords
Moderate Plaque Psoriasis, Severe Plaque Psoriasis, Plaque Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02713295
Study groupRoleWhat they receive
Subjects with Moderate to Severe Plaque PsoriasisSubjects with Moderate to Severe Plaque Psoriasis in Greece

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks post-treatment

Secondary outcomes (5)

  1. Proportion of participants achieving intermediate response

    Intermediate response is defined as participants with PASI score reduction >=50% but <75% compared to week 0 (baseline).

    Measured: Up to 12 months

  2. Proportion of participant achieving treatment success

    Treatment success rate is defined as participants with >=75% PASI score reduction compared to week 0 (baseline).

    Measured: Up to 12 months

  3. Proportion of participant with treatment failure

    Treatment failure is defined as participants with PASI score reduction <50% compared to week 0 (baseline).

    Measured: Up to 12 months

  4. 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.

    Measured: Up to 12 months

  5. Time to the first missed dose during the study observation period

    Patient diary will be reviewed to assess this information

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2016 (estimated)
  2. Study start16 Jun 2016
  3. Primary completion19 Apr 2019
  4. Study completion19 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02713295
Sponsor's protocol ID
P15-693
Acronym
CONCORDIA
Status last verified
Apr 2020
First submitted
15 Mar 2016
Last updated
15 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Moderate to Severe Plaque Psoriasis, run by AbbVie at 43 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 16 weeks post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02713295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.

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