Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting
- Conditions
- Hidradenitis Suppurativa
- Registration Number
- NCT02786576
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
- 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)
- Participants in a clinical interventional study
- Participants treated with adalimumab prior to baseline visit
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response At Week 12 Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)
- Secondary Outcome Measures
Name Time Method Changes from baseline in Dermatology Quality of Life Index (DLQI) From Week 0 to Week 52 Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Proportion of participants with moderate to severe HS who achieve a clinical response Up to week 52 Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)
Trial Locations
- Locations (83)
Meuleman, Lede, BE /ID# 154238
๐ง๐ชLede, Belgium
Vojenska nemocnice /ID# 163592
๐จ๐ฟOlomouc, Czechia
Kozni sanatorium /ID# 163591
๐จ๐ฟPraha, Czechia
Kurzen, Freising, DE /ID# 153913
๐ฉ๐ชFreising, Germany
Genl Hospital Andreas Syggros /ID# 156760
๐ฌ๐ทAthens, Greece
Miskolci Semmelweis Korhaz es /ID# 153175
๐ญ๐บMiskolc, Borsod-Abauj-Zemplen, Hungary
Pecsi Tudomanyegyetem /ID# 152612
๐ญ๐บPรฉcs, Pecs, Hungary
Markusovszky Egyetemi Oktatรณkรณrhรกz /ID# 152616
๐ญ๐บSzombathely, Vas, Hungary
Szegedi Tudomanyegyetem /ID# 152614
๐ญ๐บSzeged, Hungary
South Infirmary Victoria Univ /ID# 151095
๐ฎ๐ชCork, Ireland
St Vincent's University Hosp /ID# 151084
๐ฎ๐ชDublin, Ireland
University Hospital Waterford /ID# 153191
๐ฎ๐ชWaterford, Ireland
University Medical Ctr Maribor /ID# 164672
๐ธ๐ฎMaribor, Slovenia
Hopitaux Universitaires de Geneve /ID# 160090
๐จ๐ญGenรจve, Geneve, Switzerland
Whipps Cross Univ Hospital /ID# 150195
๐ฌ๐งLondon, London, City Of, United Kingdom
NHS Lanakshire (Monklands) /ID# 152885
๐ฌ๐งAirdire, United Kingdom
Belfast City Hospital /ID# 168411
๐ฌ๐งBelfast, United Kingdom
Univ Hospitals Birmingham NHS Foundation trust /ID# 152884
๐ฌ๐งBirmingham, United Kingdom
Heartlands Hospital /ID# 168409
๐ฌ๐งBirmingham, United Kingdom
Hull and East Yorkshire NHS /ID# 168413
๐ฌ๐งHull, United Kingdom
Ninewells Hospital /ID# 168410
๐ฌ๐งDundee, United Kingdom
Norfolk and Norwich Univ Hosp /ID# 168412
๐ฌ๐งNorwich, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 150199
๐ฌ๐งNewcastle Upon Tyne, United Kingdom
St. John's Institute of Dermat /ID# 150197
๐ฌ๐งLondon, United Kingdom
Krankenanstalt Rudolfstiftung /ID# 166804
๐ฆ๐นVienna, Wien, Austria
PP Anderlecht /ID# 154230
๐ง๐ชAnderlecht, Belgium
ULB Erasme /ID# 154216
๐ง๐ชBrussels, Belgium
UZ Antwerp /ID# 154219
๐ง๐ชEdegem, Belgium
Cliniques Universitaires Saint Luc /ID# 154217
๐ง๐ชWoluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
CHIREC- City Clinic Louise /ID# 154227
๐ง๐ชBrussels, Belgium
Boonen, Geel, BE /ID# 154233
๐ง๐ชGeel, Belgium
Polyclinique de Herstal /ID# 154226
๐ง๐ชHerstal, Belgium
UZ Gent /ID# 154221
๐ง๐ชGent, Oost-Vlaanderen, Belgium
Grand Hopital de Charleroi /ID# 154222
๐ง๐ชLoverval, Belgium
Lanssens MD Maldegem BE /ID# 154237
๐ง๐ชMaldegem, Belgium
University Hospital Zurich /ID# 160091
๐จ๐ญZurich, Switzerland
C.H.U.de Mons Borinage /ID# 154215
๐ง๐ชMons, Belgium
Dr. Pierre-Dominique Ghislain, Mons, BE /ID# 154228
๐ง๐ชMons, Belgium
CHU UCL Namur /ID# 154223
๐ง๐ชNamur, Belgium
Centre Medical 4 sapins /ID# 154236
๐ง๐ชWavre, Belgium
Ctr Hosp du Bois de l'Abbaye /ID# 154235
๐ง๐ชSeraing, Belgium
General Uni hosp of Larissa /ID# 156734
๐ฌ๐ทLarissa, Thessalia, Greece
251 Airforce General Hospital /ID# 156731
๐ฌ๐ทAthens, Greece
General Hospital of Thessaloniki George Papanikolaou /ID# 156758
๐ฌ๐ทThessaloniki, Greece
Somogy Megyei Kaposi Mor Oktat /ID# 160782
๐ญ๐บKaposvรกr, Hungary
Duplicate_General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens P /ID# 156762
๐ฌ๐ทAthens, Greece
Genl Hospital Andreas Syggros /ID# 156759
๐ฌ๐ทAthens, Greece
University Gen Hosp of Patra /ID# 156735
๐ฌ๐ทPatras, Greece
General Hospital of Thessaloni /ID# 156728
๐ฌ๐ทThessaloniki, Greece
Bacs-Kiskun Megyei Korhaz /ID# 153180
๐ญ๐บKecskemรฉt, Hungary
Semmelweis Egyetem /ID# 152613
๐ญ๐บBudapest, Hungary
Debreceni Egyetem Klinikai Kรถzpont /ID# 152615
๐ญ๐บDebrecen, Hungary
Rizk Hospital /ID# 166027
๐ฑ๐งBeirut, Lebanon
Adelaide and Meath Hosp,IE /ID# 151096
๐ฎ๐ชDublin 24, Ireland
Saint Georges Hosp Med Cent /ID# 166024
๐ฑ๐งBeirut, Lebanon
Galway University Hospital /ID# 151097
๐ฎ๐ชGalway, Ireland
Rabin Medical Center /ID# 149530
๐ฎ๐ฑPetakh Tikva, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Ctr /ID# 149528
๐ฎ๐ฑTel Aviv-Yafo, Tel-Aviv, Israel
HaEmek Medical Center /ID# 164387
๐ฎ๐ฑAfula, Israel
C/O Hotel Dieu de France /ID# 166028
๐ฑ๐งBeirut, Lebanon
Inselspital, Universitaetsklinik /ID# 160089
๐จ๐ญBern, Switzerland
GH Novo Mesto /ID# 164674
๐ธ๐ฎNovo Mesto, Slovenia
Coenen, Hasselt, BE /ID# 154234
๐ง๐ชHasselt, Belgium
CHU UCL Namur /ID# 154224
๐ง๐ชNamur, Belgium
AZ Sint-Rembert Ziekenhuis /ID# 154231
๐ง๐ชTorhout, Belgium
University General Hospital Attikon /ID# 156761
๐ฌ๐ทAthens, Attiki, Greece
Lecuyer, Thuin, Belgium /ID# 154229
๐ง๐ชThuin, Belgium
Sanatorium, s.r.o /ID# 163593
๐จ๐ฟChotoviny, Czechia
CLIDERM Bruxelles /ID# 154232
๐ง๐ชAnderlecht, Belgium
Klinikum Wels - Grieskirchen /ID# 158017
๐ฆ๐นWels, Austria
CHU de Liege /ID# 154220
๐ง๐ชLiรจge, Liege, Belgium
401 GSNA - 401 Army Gen Hosp /ID# 156729
๐ฌ๐ทฮthens, Greece
LKH-Univ. Klinikum Graz /ID# 166802
๐ฆ๐นGraz, Austria
UZ Brussel /ID# 154218
๐ง๐ชJette, Bruxelles-Capitale, Belgium
Rambam Health Care Campus /ID# 149529
๐ฎ๐ฑHaifa, Israel
St. James University Hospital /ID# 150200
๐ฌ๐งLeeds, United Kingdom
Marmara University Med Faculty /ID# 157903
๐น๐ทIstanbul, Turkey
Hadassah University Hospital /ID# 149532
๐ฎ๐ฑJerusalem, Israel
American Uni of Beirut Med Cen /ID# 166026
๐ฑ๐งBeirut, Lebanon
General Hospital Celje /ID# 164673
๐ธ๐ฎCelje, Slovenia
Univ Medical Ctr Ljubljana /ID# 164671
๐ธ๐ฎLjubljana, Slovenia
Sheba Medical Center /ID# 149531
๐ฎ๐ฑRamat Gan, Israel
Trad Hospital and Medical Cent /ID# 166025
๐ฑ๐งBeirut, Lebanon