Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-02-18 @ 10:58 AM
Study NCT ID:
NCT02713295
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2016-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 273}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'timeFrame': '16 weeks post-treatment', 'description': 'Achievement of the treatment goals during the induction phase is defined as:\n\n* Treatment Success: i.e. \\>=75% Psoriasis Area Severity Index (PASI) score reduction OR\n* Intermediate Response with Dermatology Life Quality Index (DLQI) \\<=5: i.e. PASI score reduction \\>=50% but \\<75% with DLQI \\<=5.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants achieving intermediate response', 'timeFrame': 'Up to 12 months', 'description': 'Intermediate response is defined as participants with PASI score reduction \\>=50% but \\<75% compared to week 0 (baseline).'}, {'measure': 'Proportion of participant achieving treatment success', 'timeFrame': 'Up to 12 months', 'description': 'Treatment success rate is defined as participants with \\>=75% PASI score reduction compared to week 0 (baseline).'}, {'measure': 'Proportion of participant with treatment failure', 'timeFrame': 'Up to 12 months', 'description': 'Treatment failure is defined as participants with PASI score reduction \\<50% compared to week 0 (baseline).'}, {'measure': 'Proportion of participants achieving the treatment goals', 'timeFrame': 'Up to 12 months', 'description': 'According to the European Consensus Programme (ECP) guidelines, achievement of the treatment goals during the maintenance phase is defined as:\n\n* Treatment Success: i.e. \\>=75% Psoriasis Area Severity Index (PASI) score reduction compared to the time of therapy initiation (i.e. baseline) (or)\n* Intermediate Response with Dermatology Life Quality Index (DLQI) \\<=5: i.e. PASI score reduction \\>=50% but \\<75% compared to baseline, with DLQI \\<=5.'}, {'measure': 'Time to the first missed dose during the study observation period', 'timeFrame': 'Up to 12 months', 'description': 'Patient diary will be reviewed to assess this information'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderate Plaque Psoriasis', 'Severe Plaque Psoriasis', 'Plaque Psoriasis'], 'conditions': ['Moderate to Severe Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with Moderate to Severe Plaque Psoriasis in Greece', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* 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\n* Patients with an available Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores at the start of adalimumab treatment\n* Patients able and willing to provide written informed consent and to comply with the requirements of this study protocol\n* Patients with a signed informed consent document\n\nExclusion Criteria:\n\n* Patients should not have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular)\n* Patients for whom treatment with adalimumab has been initiated more than 2 weeks prior to their enrolment into the study\n* Patients that meet any of the contraindications to the administration of the study drug according to the latest version of the locally approved SmPC\n* Patients who have previously been exposed to adalimumab unless a period of at least 6 months from the last dose has elapsed\n* 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."}, 'identificationModule': {'nctId': 'NCT02713295', 'acronym': 'CONCORDIA', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'P15-693'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with Moderate to Severe Plaque Psoriasis', 'description': 'Subjects with Moderate to Severe Plaque Psoriasis in Greece'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12562', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'General Univ Hosp "Attikon" /ID# 149517', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '18536', 'city': 'Piraeus', 'state': 'Attica', 'country': 'Greece', 'facility': 'Tzaneio general hospital of Piraeus /ID# 149518', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'zip': '415 00', 'city': 'Larissa', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'General Uni hosp of Larissa /ID# 149688', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '415 00', 'city': 'Larissa', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'General Uni hosp of Larissa /ID# 151442', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '27200', 'city': 'Amaliáda', 'country': 'Greece', 'facility': 'PP of Konstantinos Tsaousis /ID# 149704', 'geoPoint': {'lat': 37.79842, 'lon': 21.35068}}, {'zip': '70300', 'city': 'Arkalochóri', 'country': 'Greece', 'facility': 'PP of Maria Sifaki /ID# 149717', 'geoPoint': {'lat': 35.14634, 'lon': 25.26538}}, {'zip': '10676', 'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 158934', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '10682', 'city': 'Athens', 'country': 'Greece', 'facility': 'PP of Michael Kakepis /ID# 149693', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11251', 'city': 'Athens', 'country': 'Greece', 'facility': 'PP of Georgios Papadopoulos /ID# 149712', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11525', 'city': 'Athens', 'country': 'Greece', 'facility': 'PP of Ioannis Krikellis /ID# 149715', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11526', 'city': 'Athens', 'country': 'Greece', 'facility': 'PP of Markos Papakonstantis /ID# 149702', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11634', 'city': 'Athens', 'country': 'Greece', 'facility': 'PP of Panagiotis Deligiannis /ID# 149708', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '16121', 'city': 'Athens', 'country': 'Greece', 'facility': 'Genl Hospital Andreas Syggros /ID# 149516', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '16121', 'city': 'Athens', 'country': 'Greece', 'facility': 'Genl Hospital Andreas Syggros /ID# 149687', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '15343', 'city': 'Athens, AGIA Paraskeui', 'country': 'Greece', 'facility': 'PP of Ekaterini Galaterou /ID# 149713', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11626', 'city': 'Athens, Ampelokipi', 'country': 'Greece', 'facility': 'PP of Ioannis Papaggelopoulos /ID# 149703'}, {'zip': '15231', 'city': 'Athens, Chalandri', 'country': 'Greece', 'facility': 'PP of Antonios Seretis /ID# 149714'}, {'zip': '16562', 'city': 'Athens, Glyfada', 'country': 'Greece', 'facility': 'PP of Despoina Arnaoutoglou /ID# 149707'}, {'zip': '16675', 'city': 'Athens, Glyfada', 'country': 'Greece', 'facility': 'PP of Maria Loukatou /ID# 149706'}, {'zip': '14341', 'city': 'Athens, NEA Filadelfeia', 'country': 'Greece', 'facility': 'PP of Eirini Stefanaki /ID# 149695'}, {'zip': '17124', 'city': 'Athens, NEA Smyrni', 'country': 'Greece', 'facility': 'PP of Pantelis Aronis /ID# 149705'}, {'zip': '16672', 'city': 'Athens, VARI', 'country': 'Greece', 'facility': 'PP of Theognosia Vergou /ID# 149694'}, {'zip': '14121', 'city': 'Athens,neo Irakleio', 'country': 'Greece', 'facility': 'PP of Ioannis Mparkis /ID# 149711'}, {'zip': '71201', 'city': 'Crete, Heraklion', 'country': 'Greece', 'facility': 'PP of Vasilios Chatzakis /ID# 149718', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'zip': '71305', 'city': 'Crete, Heraklion', 'country': 'Greece', 'facility': 'PP of Kalliopi Karamanolaki /ID# 149720', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'zip': '66100', 'city': 'Drama', 'country': 'Greece', 'facility': 'PP of Vasiliki Tzirka /ID# 149722', 'geoPoint': {'lat': 41.15283, 'lon': 24.1473}}, {'zip': '24100', 'city': 'Kalamata', 'country': 'Greece', 'facility': 'Kontargiris, MD, Kalamata, GR /ID# 151444', 'geoPoint': {'lat': 37.03913, 'lon': 22.11265}}, {'zip': '14233', 'city': 'Nea Ionia', 'country': 'Greece', 'facility': 'Konstantopouleio General Hospi /ID# 149690', 'geoPoint': {'lat': 38.0357, 'lon': 23.75733}}, {'zip': '68200', 'city': 'Orestiáda', 'country': 'Greece', 'facility': 'PP of Konstantinos Markakis /ID# 149723', 'geoPoint': {'lat': 41.50306, 'lon': 26.52972}}, {'zip': '26221', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'Rigatos, MD, Patra, GR /ID# 151446', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '26504', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'University Gen Hosp of Patra /ID# 149691', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '35300', 'city': 'Stilís', 'country': 'Greece', 'facility': 'PP of Chrysa Zisimou Politopou /ID# 149728', 'geoPoint': {'lat': 38.91667, 'lon': 22.61667}}, {'zip': '54623', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'PP of Aimilios Lallas /ID# 149721', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54623', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'PP of Pantelis Souvantzidis /ID# 149726', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54623', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'PP of Stelios Charalampidis /ID# 149727', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '54643', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'PP of Georgios Chaidemenos /ID# 149724', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '55134', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'General Hospital of Thessaloni /ID# 149692', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '55236', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Kallidis, MD, Thessaloniki, GR /ID# 151443', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '57010', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'General Hospital of Thessaloniki George Papanikolaou /ID# 149515', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '59132', 'city': 'Véroia', 'country': 'Greece', 'facility': 'Manousari, MD, Veroia, GR /ID# 151445', 'geoPoint': {'lat': 40.52437, 'lon': 22.20242}}, {'zip': '38221', 'city': 'Volos', 'country': 'Greece', 'facility': 'PP of Prodromos Christoforidis /ID# 149730', 'geoPoint': {'lat': 39.36923, 'lon': 22.94769}}, {'zip': '67100', 'city': 'Xánthi', 'country': 'Greece', 'facility': 'General Hospital of Xanthi /ID# 149519', 'geoPoint': {'lat': 41.13488, 'lon': 24.888}}, {'zip': '20400', 'city': 'Xilokastro', 'country': 'Greece', 'facility': 'PP of Stathis Gkourvelos /ID# 149709'}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}