Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting

Completed

• 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

Study Timeline

• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Study Start: 2016-07-05
• Primary Completion: 2019-01-07
• Study Completion: 2019-01-07
• Status Verified: 2019-09
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

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; 🇧🇪 Lede, Belgium

Vojenska nemocnice /ID# 163592; 🇨🇿 Olomouc, Czechia

Kozni sanatorium /ID# 163591; 🇨🇿 Praha, Czechia

Kurzen, Freising, DE /ID# 153913; 🇩🇪 Freising, Germany

Genl Hospital Andreas Syggros /ID# 156760; 🇬🇷 Athens, Greece

Miskolci Semmelweis Korhaz es /ID# 153175; 🇭🇺 Miskolc, Borsod-Abauj-Zemplen, Hungary

Pecsi Tudomanyegyetem /ID# 152612; 🇭🇺 Pécs, Pecs, Hungary

Markusovszky Egyetemi Oktatókórház /ID# 152616; 🇭🇺 Szombathely, Vas, Hungary

Szegedi Tudomanyegyetem /ID# 152614; 🇭🇺 Szeged, Hungary

South Infirmary Victoria Univ /ID# 151095; 🇮🇪 Cork, Ireland

St Vincent's University Hosp /ID# 151084; 🇮🇪 Dublin, Ireland

University Hospital Waterford /ID# 153191; 🇮🇪 Waterford, Ireland

University Medical Ctr Maribor /ID# 164672; 🇸🇮 Maribor, Slovenia

Hopitaux Universitaires de Geneve /ID# 160090; 🇨🇭 Genève, Geneve, Switzerland

Whipps Cross Univ Hospital /ID# 150195; 🇬🇧 London, London, City Of, United Kingdom

NHS Lanakshire (Monklands) /ID# 152885; 🇬🇧 Airdire, United Kingdom

Belfast City Hospital /ID# 168411; 🇬🇧 Belfast, United Kingdom

Univ Hospitals Birmingham NHS Foundation trust /ID# 152884; 🇬🇧 Birmingham, United Kingdom

Heartlands Hospital /ID# 168409; 🇬🇧 Birmingham, United Kingdom

Hull and East Yorkshire NHS /ID# 168413; 🇬🇧 Hull, United Kingdom

Ninewells Hospital /ID# 168410; 🇬🇧 Dundee, United Kingdom

Norfolk and Norwich Univ Hosp /ID# 168412; 🇬🇧 Norwich, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 150199; 🇬🇧 Newcastle Upon Tyne, United Kingdom

St. John's Institute of Dermat /ID# 150197; 🇬🇧 London, United Kingdom

Krankenanstalt Rudolfstiftung /ID# 166804; 🇦🇹 Vienna, Wien, Austria

PP Anderlecht /ID# 154230; 🇧🇪 Anderlecht, Belgium

ULB Erasme /ID# 154216; 🇧🇪 Brussels, Belgium

UZ Antwerp /ID# 154219; 🇧🇪 Edegem, Belgium

Cliniques Universitaires Saint Luc /ID# 154217; 🇧🇪 Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium

CHIREC- City Clinic Louise /ID# 154227; 🇧🇪 Brussels, Belgium

Boonen, Geel, BE /ID# 154233; 🇧🇪 Geel, Belgium

Polyclinique de Herstal /ID# 154226; 🇧🇪 Herstal, Belgium

UZ Gent /ID# 154221; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

Grand Hopital de Charleroi /ID# 154222; 🇧🇪 Loverval, Belgium

Lanssens MD Maldegem BE /ID# 154237; 🇧🇪 Maldegem, Belgium

University Hospital Zurich /ID# 160091; 🇨🇭 Zurich, Switzerland

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

Centre Medical 4 sapins /ID# 154236; 🇧🇪 Wavre, Belgium

Ctr Hosp du Bois de l'Abbaye /ID# 154235; 🇧🇪 Seraing, Belgium

General Uni hosp of Larissa /ID# 156734; 🇬🇷 Larissa, Thessalia, Greece

251 Airforce General Hospital /ID# 156731; 🇬🇷 Athens, Greece

General Hospital of Thessaloniki George Papanikolaou /ID# 156758; 🇬🇷 Thessaloniki, Greece

Somogy Megyei Kaposi Mor Oktat /ID# 160782; 🇭🇺 Kaposvár, Hungary

Duplicate_General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens P /ID# 156762; 🇬🇷 Athens, Greece

Genl Hospital Andreas Syggros /ID# 156759; 🇬🇷 Athens, Greece

University Gen Hosp of Patra /ID# 156735; 🇬🇷 Patras, Greece

General Hospital of Thessaloni /ID# 156728; 🇬🇷 Thessaloniki, Greece

Bacs-Kiskun Megyei Korhaz /ID# 153180; 🇭🇺 Kecskemét, Hungary

Semmelweis Egyetem /ID# 152613; 🇭🇺 Budapest, Hungary

Debreceni Egyetem Klinikai Központ /ID# 152615; 🇭🇺 Debrecen, Hungary

Rizk Hospital /ID# 166027; 🇱🇧 Beirut, Lebanon

Adelaide and Meath Hosp,IE /ID# 151096; 🇮🇪 Dublin 24, Ireland

Saint Georges Hosp Med Cent /ID# 166024; 🇱🇧 Beirut, Lebanon

Galway University Hospital /ID# 151097; 🇮🇪 Galway, Ireland

Rabin Medical Center /ID# 149530; 🇮🇱 Petakh Tikva, Tel-Aviv, Israel

Tel Aviv Sourasky Medical Ctr /ID# 149528; 🇮🇱 Tel Aviv-Yafo, Tel-Aviv, Israel

HaEmek Medical Center /ID# 164387; 🇮🇱 Afula, Israel

C/O Hotel Dieu de France /ID# 166028; 🇱🇧 Beirut, Lebanon

Inselspital, Universitaetsklinik /ID# 160089; 🇨🇭 Bern, Switzerland

GH Novo Mesto /ID# 164674; 🇸🇮 Novo Mesto, Slovenia

Coenen, Hasselt, BE /ID# 154234; 🇧🇪 Hasselt, Belgium

CHU UCL Namur /ID# 154224; 🇧🇪 Namur, Belgium

AZ Sint-Rembert Ziekenhuis /ID# 154231; 🇧🇪 Torhout, Belgium

University General Hospital Attikon /ID# 156761; 🇬🇷 Athens, Attiki, Greece

Lecuyer, Thuin, Belgium /ID# 154229; 🇧🇪 Thuin, Belgium

Sanatorium, s.r.o /ID# 163593; 🇨🇿 Chotoviny, Czechia

CLIDERM Bruxelles /ID# 154232; 🇧🇪 Anderlecht, Belgium

Klinikum Wels - Grieskirchen /ID# 158017; 🇦🇹 Wels, Austria

CHU de Liege /ID# 154220; 🇧🇪 Liège, Liege, Belgium

401 GSNA - 401 Army Gen Hosp /ID# 156729; 🇬🇷 Αthens, Greece

LKH-Univ. Klinikum Graz /ID# 166802; 🇦🇹 Graz, Austria

UZ Brussel /ID# 154218; 🇧🇪 Jette, Bruxelles-Capitale, Belgium

Rambam Health Care Campus /ID# 149529; 🇮🇱 Haifa, Israel

St. James University Hospital /ID# 150200; 🇬🇧 Leeds, United Kingdom

Marmara University Med Faculty /ID# 157903; 🇹🇷 Istanbul, Turkey

Hadassah University Hospital /ID# 149532; 🇮🇱 Jerusalem, Israel

American Uni of Beirut Med Cen /ID# 166026; 🇱🇧 Beirut, Lebanon

General Hospital Celje /ID# 164673; 🇸🇮 Celje, Slovenia

Univ Medical Ctr Ljubljana /ID# 164671; 🇸🇮 Ljubljana, Slovenia

Sheba Medical Center /ID# 149531; 🇮🇱 Ramat Gan, Israel

Trad Hospital and Medical Cent /ID# 166025; 🇱🇧 Beirut, Lebanon