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Trial record 23 of 762 for:    plaque | "Psoriasis"

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)

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ClinicalTrials.gov Identifier: NCT02713295
Recruitment Status : Active, not recruiting
First Posted : March 18, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease
Moderate to Severe Plaque Psoriasis

Study Type : Observational
Actual Enrollment : 273 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 16, 2016
Estimated Primary Completion Date : April 21, 2019
Estimated Study Completion Date : April 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

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



Primary Outcome Measures :
  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) [ 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with Moderate to Severe Plaque Psoriasis in Greece
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713295


Locations
Greece
General Univ Hosp "Attikon" /ID# 149517
Athens, Attiki, Greece, 124 61
Tzaneio general hospital of Piraeus /ID# 149518
Piraeus, Attiki, Greece, 18536
General Uni hosp of Larissa /ID# 149688
Larissa, Thessalia, Greece, 415 00
General Uni hosp of Larissa /ID# 151442
Larissa, Thessalia, Greece, 415 00
PP of Konstantinos Tsaousis /ID# 149704
Amaliada, Greece, 27200
PP of Maria Sifaki /ID# 149717
Arkalochori, Greece, 70300
PP of Ekaterini Galaterou /ID# 149713
Athens, AGIA Paraskeui, Greece, 15343
PP of Ioannis Papaggelopoulos /ID# 149703
Athens, Ampelokipi, Greece, 11626
PP of Antonios Seretis /ID# 149714
Athens, Chalandri, Greece, 15231
PP of Despoina Arnaoutoglou /ID# 149707
Athens, Glyfada, Greece, 16562
PP of Maria Loukatou /ID# 149706
Athens, Glyfada, Greece, 16675
PP of Eirini Stefanaki /ID# 149695
Athens, NEA Filadelfeia, Greece, 14341
PP of Pantelis Aronis /ID# 149705
Athens, NEA Smyrni, Greece, 17124
PP of Theognosia Vergou /ID# 149694
Athens, VARI, Greece, 16672
PP of Ioannis Mparkis /ID# 149711
Athens,neo Irakleio, Greece, 14121
PP of Michael Kakepis /ID# 149693
Athens, Greece, 10682
PP of Georgios Papadopoulos /ID# 149712
Athens, Greece, 11251
Gen Hosp Athens Evangelismos /ID# 158934
Athens, Greece, 115 21
PP of Ioannis Krikellis /ID# 149715
Athens, Greece, 11525
PP of Markos Papakonstantis /ID# 149702
Athens, Greece, 11526
PP of Panagiotis Deligiannis /ID# 149708
Athens, Greece, 11634
Genl Hospital Andreas Syggros /ID# 149516
Athens, Greece, 16121
Genl Hospital Andreas Syggros /ID# 149687
Athens, Greece, 16121
PP of Vasilios Chatzakis /ID# 149718
Crete, Heraklion, Greece, 71201
PP of Kalliopi Karamanolaki /ID# 149720
Crete, Heraklion, Greece, 71305
PP of Vasiliki Tzirka /ID# 149722
Drama, Greece, 66100
Kontargiris, MD, Kalamata, GR /ID# 151444
Kalamata, Greece, 24100
Konstantopouleio General Hospi /ID# 149690
Nea Ionia, Greece, 14233
PP of Konstantinos Markakis /ID# 149723
Orestiada, Greece, 68200
Rigatos, MD, Patra, GR /ID# 151446
Patras, Greece, 26221
University Gen Hosp of Patra /ID# 149691
Patras, Greece, 26504
PP of Chrysa Zisimou Politopou /ID# 149728
Stylida, Greece, 35300
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, 54623
PP of Georgios Chaidemenos /ID# 149724
Thessaloniki, Greece, 54643
General Hospital of Thessaloni /ID# 149692
Thessaloniki, Greece, 55134
Kallidis, MD, Thessaloniki, GR /ID# 151443
Thessaloniki, Greece, 55236
General Hospital of Thessaloniki "George Papanikolaou" /ID# 149515
Thessaloniki, Greece, 57010
Manousari, MD, Veroia, GR /ID# 151445
Veroia, Greece, 59132
PP of Prodromos Christoforidis /ID# 149730
Volos, Greece, 38221
General Hospital of Xanthi /ID# 149519
Xanthi, Greece, 67100
PP of Stathis Gkourvelos /ID# 149709
Xilokastro, Greece, 20400
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02713295     History of Changes
Other Study ID Numbers: P15-693
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by AbbVie:
Moderate Plaque Psoriasis
Severe Plaque Psoriasis
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents