Clinical trial NCT02786576: Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting
Official title: Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting - HARMONY Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Keywords: Moderate to Severe Hidradenitis Suppurativa
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-06-01
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hidradenitis Suppurativa (HS) participants receiving adalimumab

Brief summary: This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis Suppurativa (HS) patients in the real world setting. The objectives of this study are to estimate the effectiveness of adalimumab treatment on disease severity, to estimate the impact of adalimumab treatment on patients' quality of life, psychological effect, work productivity and healthcare resource utilization and to describe treatment practices over the study period.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of moderate to severe Hidradenitis Suppurativa
* The decision to treat with adalimumab (Humira) is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the participant to participate in this study
* Participants willing to be involved in the study and to sign patient authorization form to use and disclose personal health information (or informed consent, where applicable)

Exclusion Criteria:

* Participants in a clinical interventional study
* Participants treated with adalimumab prior to baseline visit

Primary outcomes:
measure: Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response
timeFrame: At Week 12
Secondary outcomes:
measure: Proportion of participants with moderate to severe HS who achieve a clinical response
timeFrame: Up to week 52
measure: Changes from baseline in Dermatology Quality of Life Index (DLQI)
timeFrame: From Week 0 to Week 52
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Krankenanstalt Rudolfstiftung /ID# 166804
state: Wien
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz /ID# 166802
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen /ID# 158017
city: Jette
country: Belgium
facility: UZ Brussel /ID# 154218
state: Bruxelles-Capitale
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc /ID# 154217
state: Bruxelles-Capitale
city: Liège
country: Belgium
facility: CHU de Liege /ID# 154220
state: Liege
city: Gent
country: Belgium
facility: UZ Gent /ID# 154221
state: Oost-Vlaanderen
city: Anderlecht
country: Belgium
facility: CLIDERM Bruxelles /ID# 154232
city: Anderlecht
country: Belgium
facility: PP Anderlecht /ID# 154230
city: Brussels
country: Belgium
facility: CHIREC- City Clinic Louise /ID# 154227
city: Brussels
country: Belgium
facility: ULB Erasme /ID# 154216
city: Edegem
country: Belgium
facility: UZ Antwerp /ID# 154219
city: Geel
country: Belgium
facility: Boonen, Geel, BE /ID# 154233
city: Hasselt
country: Belgium
facility: Coenen, Hasselt, BE /ID# 154234
city: Herstal
country: Belgium
facility: Polyclinique de Herstal /ID# 154226
city: Lede
country: Belgium
facility: Meuleman, Lede, BE /ID# 154238
city: Loverval
country: Belgium
facility: Grand Hopital de Charleroi /ID# 154222
city: Maldegem
country: Belgium
facility: Lanssens MD Maldegem BE /ID# 154237
city: Mons
country: Belgium
facility: C.H.U.de Mons Borinage /ID# 154215
city: Mons
country: Belgium
facility: Dr. Pierre-Dominique Ghislain, Mons, BE /ID# 154228
city: Namur
country: Belgium
facility: CHU UCL Namur /ID# 154223
city: Namur
country: Belgium
facility: CHU UCL Namur /ID# 154224
city: Seraing
country: Belgium
facility: Ctr Hosp du Bois de l'Abbaye /ID# 154235
city: Thuin
country: Belgium
facility: Lecuyer, Thuin, Belgium /ID# 154229
city: Torhout
country: Belgium
facility: AZ Sint-Rembert Ziekenhuis /ID# 154231
city: Wavre
country: Belgium
facility: Centre Medical 4 sapins /ID# 154236
city: Chotoviny
country: Czechia
facility: Sanatorium, s.r.o /ID# 163593
city: Olomouc
country: Czechia
facility: Vojenska nemocnice /ID# 163592
city: Praha
country: Czechia
facility: Kozni sanatorium /ID# 163591
city: Freising
country: Germany
facility: Kurzen, Freising, DE /ID# 153913
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 156761
state: Attiki
city: Larissa
country: Greece
facility: General Uni hosp of Larissa /ID# 156734
state: Thessalia
city: Athens
country: Greece
facility: Duplicate_General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens P /ID# 156762
city: Athens
country: Greece
facility: 251 Airforce General Hospital /ID# 156731
city: Athens
country: Greece
facility: Genl Hospital Andreas Syggros /ID# 156759
city: Athens
country: Greece
facility: Genl Hospital Andreas Syggros /ID# 156760
city: Patras
country: Greece
facility: University Gen Hosp of Patra /ID# 156735
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloni /ID# 156728
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki George Papanikolaou /ID# 156758
city: Αthens
country: Greece
facility: 401 GSNA - 401 Army Gen Hosp /ID# 156729
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Korhaz es /ID# 153175
state: Borsod-Abauj-Zemplen
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem /ID# 152612
state: Pecs
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház /ID# 152616
state: Vas
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 152613
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ /ID# 152615
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktat /ID# 160782
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz /ID# 153180
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem /ID# 152614
city: Cork
country: Ireland
facility: South Infirmary Victoria Univ /ID# 151095
city: Dublin 24
country: Ireland
facility: Adelaide and Meath Hosp,IE /ID# 151096
city: Dublin
country: Ireland
facility: St Vincent's University Hosp /ID# 151084
city: Galway
country: Ireland
facility: Galway University Hospital /ID# 151097
city: Waterford
country: Ireland
facility: University Hospital Waterford /ID# 153191
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 149530
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Ctr /ID# 149528
state: Tel-Aviv
city: Afula
country: Israel
facility: HaEmek Medical Center /ID# 164387
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 149529
city: Jerusalem
country: Israel
facility: Hadassah University Hospital /ID# 149532
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 149531
city: Beirut
country: Lebanon
facility: Rizk Hospital /ID# 166027
city: Beirut
country: Lebanon
facility: Saint Georges Hosp Med Cent /ID# 166024
city: Beirut
country: Lebanon
facility: American Uni of Beirut Med Cen /ID# 166026
city: Beirut
country: Lebanon
facility: Trad Hospital and Medical Cent /ID# 166025
city: Beirut
country: Lebanon
facility: C/O Hotel Dieu de France /ID# 166028
city: Celje
country: Slovenia
facility: General Hospital Celje /ID# 164673
city: Ljubljana
country: Slovenia
facility: Univ Medical Ctr Ljubljana /ID# 164671
city: Maribor
country: Slovenia
facility: University Medical Ctr Maribor /ID# 164672
city: Novo Mesto
country: Slovenia
facility: GH Novo Mesto /ID# 164674
city: Genève
country: Switzerland
facility: Hopitaux Universitaires de Geneve /ID# 160090
state: Geneve
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsklinik /ID# 160089
city: Zurich
country: Switzerland
facility: University Hospital Zurich /ID# 160091
city: Istanbul
country: Turkey
facility: Marmara University Med Faculty /ID# 157903
city: London
country: United Kingdom
facility: Whipps Cross Univ Hospital /ID# 150195
state: London, City Of
city: Airdire
country: United Kingdom
facility: NHS Lanakshire (Monklands) /ID# 152885
city: Belfast
country: United Kingdom
facility: Belfast City Hospital /ID# 168411
city: Birmingham
country: United Kingdom
facility: Univ Hospitals Birmingham NHS Foundation trust /ID# 152884
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital /ID# 168409
city: Dundee
country: United Kingdom
facility: Ninewells Hospital /ID# 168410
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire NHS /ID# 168413
city: Leeds
country: United Kingdom
facility: St. James University Hospital /ID# 150200
city: London
country: United Kingdom
facility: St. John's Institute of Dermat /ID# 150197
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 150199
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Univ Hosp /ID# 168412
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: