Hidradenitis Suppurativa Clinical Trial
— HARMONYOfficial title:
Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting - HARMONY Study
| NCT number | NCT02786576 |
| Other study ID # | P15-769 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 5, 2016 |
| Est. completion date | January 7, 2019 |
| Verified date | September 2019 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 236 |
| Est. completion date | January 7, 2019 |
| Est. primary completion date | January 7, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | LKH-Univ. Klinikum Graz /ID# 166802 | Graz | |
| Austria | Krankenanstalt Rudolfstiftung /ID# 166804 | Vienna | Wien |
| Austria | Klinikum Wels - Grieskirchen /ID# 158017 | Wels | |
| Belgium | CLIDERM Bruxelles /ID# 154232 | Anderlecht | |
| Belgium | PP Anderlecht /ID# 154230 | Anderlecht | |
| Belgium | CHIREC- City Clinic Louise /ID# 154227 | Brussels | |
| Belgium | ULB Erasme /ID# 154216 | Brussels | |
| Belgium | UZ Antwerp /ID# 154219 | Edegem | |
| Belgium | Boonen, Geel, BE /ID# 154233 | Geel | |
| Belgium | UZ Gent /ID# 154221 | Gent | Oost-Vlaanderen |
| Belgium | Coenen, Hasselt, BE /ID# 154234 | Hasselt | |
| Belgium | Polyclinique de Herstal /ID# 154226 | Herstal | |
| Belgium | UZ Brussel /ID# 154218 | Jette | Bruxelles-Capitale |
| Belgium | Meuleman, Lede, BE /ID# 154238 | Lede | |
| Belgium | CHU de Liege /ID# 154220 | Liège | Liege |
| Belgium | Grand Hopital de Charleroi /ID# 154222 | Loverval | |
| Belgium | Lanssens MD Maldegem BE /ID# 154237 | Maldegem | |
| Belgium | C.H.U.de Mons Borinage /ID# 154215 | Mons | |
| Belgium | Dr. Pierre-Dominique Ghislain, Mons, BE /ID# 154228 | Mons | |
| Belgium | CHU UCL Namur /ID# 154223 | Namur | |
| Belgium | CHU UCL Namur /ID# 154224 | Namur | |
| Belgium | Ctr Hosp du Bois de l'Abbaye /ID# 154235 | Seraing | |
| Belgium | Lecuyer, Thuin, Belgium /ID# 154229 | Thuin | |
| Belgium | AZ Sint-Rembert Ziekenhuis /ID# 154231 | Torhout | |
| Belgium | Centre Medical 4 sapins /ID# 154236 | Wavre | |
| Belgium | Cliniques Universitaires Saint Luc /ID# 154217 | Woluwe-Saint-Lambert | Bruxelles-Capitale |
| Czechia | Sanatorium, s.r.o /ID# 163593 | Chotoviny | |
| Czechia | Vojenska nemocnice /ID# 163592 | Olomouc | |
| Czechia | Kozni sanatorium /ID# 163591 | Praha | |
| Germany | Kurzen, Freising, DE /ID# 153913 | Freising | |
| Greece | 401 GSNA - 401 Army Gen Hosp /ID# 156729 | ?thens | |
| Greece | 251 Airforce General Hospital /ID# 156731 | Athens | |
| Greece | Duplicate_General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens P /ID# 156762 | Athens | |
| Greece | Genl Hospital Andreas Syggros /ID# 156759 | Athens | |
| Greece | Genl Hospital Andreas Syggros /ID# 156760 | Athens | |
| Greece | University General Hospital Attikon /ID# 156761 | Athens | Attiki |
| Greece | General Uni hosp of Larissa /ID# 156734 | Larissa | Thessalia |
| Greece | University Gen Hosp of Patra /ID# 156735 | Patras | |
| Greece | General Hospital of Thessaloni /ID# 156728 | Thessaloniki | |
| Greece | General Hospital of Thessaloniki George Papanikolaou /ID# 156758 | Thessaloniki | |
| Hungary | Semmelweis Egyetem /ID# 152613 | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Központ /ID# 152615 | Debrecen | |
| Hungary | Somogy Megyei Kaposi Mor Oktat /ID# 160782 | Kaposvár | |
| Hungary | Bacs-Kiskun Megyei Korhaz /ID# 153180 | Kecskemét | |
| Hungary | Miskolci Semmelweis Korhaz es /ID# 153175 | Miskolc | Borsod-Abauj-Zemplen |
| Hungary | Pecsi Tudomanyegyetem /ID# 152612 | Pécs | Pecs |
| Hungary | Szegedi Tudomanyegyetem /ID# 152614 | Szeged | |
| Hungary | Markusovszky Egyetemi Oktatókórház /ID# 152616 | Szombathely | Vas |
| Ireland | South Infirmary Victoria Univ /ID# 151095 | Cork | |
| Ireland | St Vincent's University Hosp /ID# 151084 | Dublin | |
| Ireland | Adelaide and Meath Hosp,IE /ID# 151096 | Dublin 24 | |
| Ireland | Galway University Hospital /ID# 151097 | Galway | |
| Ireland | University Hospital Waterford /ID# 153191 | Waterford | |
| Israel | HaEmek Medical Center /ID# 164387 | Afula | |
| Israel | Rambam Health Care Campus /ID# 149529 | Haifa | |
| Israel | Hadassah University Hospital /ID# 149532 | Jerusalem | |
| Israel | Rabin Medical Center /ID# 149530 | Petakh Tikva | Tel-Aviv |
| Israel | Sheba Medical Center /ID# 149531 | Ramat Gan | |
| Israel | Tel Aviv Sourasky Medical Ctr /ID# 149528 | Tel Aviv-Yafo | Tel-Aviv |
| Lebanon | American Uni of Beirut Med Cen /ID# 166026 | Beirut | |
| Lebanon | C/O Hotel Dieu de France /ID# 166028 | Beirut | |
| Lebanon | Rizk Hospital /ID# 166027 | Beirut | |
| Lebanon | Saint Georges Hosp Med Cent /ID# 166024 | Beirut | |
| Lebanon | Trad Hospital and Medical Cent /ID# 166025 | Beirut | |
| Slovenia | General Hospital Celje /ID# 164673 | Celje | |
| Slovenia | Univ Medical Ctr Ljubljana /ID# 164671 | Ljubljana | |
| Slovenia | University Medical Ctr Maribor /ID# 164672 | Maribor | |
| Slovenia | GH Novo Mesto /ID# 164674 | Novo Mesto | |
| Switzerland | Inselspital, Universitaetsklinik /ID# 160089 | Bern | |
| Switzerland | Hopitaux Universitaires de Geneve /ID# 160090 | Genève | Geneve |
| Switzerland | University Hospital Zurich /ID# 160091 | Zurich | |
| Turkey | Marmara University Med Faculty /ID# 157903 | Istanbul | |
| United Kingdom | NHS Lanakshire (Monklands) /ID# 152885 | Airdire | |
| United Kingdom | Belfast City Hospital /ID# 168411 | Belfast | |
| United Kingdom | Heartlands Hospital /ID# 168409 | Birmingham | |
| United Kingdom | Univ Hospitals Birmingham NHS Foundation trust /ID# 152884 | Birmingham | |
| United Kingdom | Ninewells Hospital /ID# 168410 | Dundee | |
| United Kingdom | Hull and East Yorkshire NHS /ID# 168413 | Hull | |
| United Kingdom | St. James University Hospital /ID# 150200 | Leeds | |
| United Kingdom | St. John's Institute of Dermat /ID# 150197 | London | |
| United Kingdom | Whipps Cross Univ Hospital /ID# 150195 | London | London, City Of |
| United Kingdom | The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 150199 | Newcastle Upon Tyne | |
| United Kingdom | Norfolk and Norwich Univ Hosp /ID# 168412 | Norwich |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Austria, Belgium, Czechia, Germany, Greece, Hungary, Ireland, Israel, Lebanon, Slovenia, Switzerland, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response | Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR) | At Week 12 | |
| Secondary | Proportion of participants with moderate to severe HS who achieve a clinical response | Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR) | Up to week 52 | |
| Secondary | Changes from baseline in Dermatology Quality of Life Index (DLQI) | 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. | From Week 0 to Week 52 |
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