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

NCT02786576 | Completed

• 1 other identifier: P15-769
• Study Type: observational
• Target: 236
• Locations: 13 countries
• Sites: 83

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.

Conditions

Hidradenitis Suppurativa

Keywords

Moderate to Severe Hidradenitis Suppurativa; Adalimumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of participants with moderate to severe HS who achieve a clinical response

  Up to week 52

• Changes from baseline in Dermatology Quality of Life Index (DLQI)

  From Week 0 to Week 52

Study Arms (1)

Participants receiving adalimumab

Hidradenitis Suppurativa (HS) participants receiving adalimumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hidradenitis Suppurativa (HS) participants receiving adalimumab

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (83)

Krankenanstalt Rudolfstiftung /ID# 166804

Vienna, Vienna, 1030, Austria

Location

LKH-Univ. Klinikum Graz /ID# 166802

Graz, 8036, Austria

Location

Klinikum Wels - Grieskirchen /ID# 158017

Wels, 4600, Austria

Location

UZ Brussel /ID# 154218

Jette, Brussels Capital, 1090, Belgium

Location

Cliniques Universitaires Saint Luc /ID# 154217

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

CHU de Liege /ID# 154220

Liège, Liege, 4000, Belgium

Location

UZ Gent /ID# 154221

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

CLIDERM Bruxelles /ID# 154232

Anderlecht, 1070, Belgium

Location

PP Anderlecht /ID# 154230

Anderlecht, 1070, Belgium

Location

CHIREC- City Clinic Louise /ID# 154227

Brussels, 1000, Belgium

Location

ULB Erasme /ID# 154216

Brussels, 1070, Belgium

Location

UZ Antwerp /ID# 154219

Edegem, 2650, Belgium

Location

Boonen, Geel, BE /ID# 154233

Geel, 2440, Belgium

Location

Coenen, Hasselt, BE /ID# 154234

Hasselt, 3500, Belgium

Location

Polyclinique de Herstal /ID# 154226

Herstal, 4040, Belgium

Location

Meuleman, Lede, BE /ID# 154238

Lede, 9340, Belgium

Location

Grand Hopital de Charleroi /ID# 154222

Loverval, 6280, Belgium

Location

Lanssens MD Maldegem BE /ID# 154237

Maldegem, 9990, Belgium

Location

C.H.U.de Mons Borinage /ID# 154215

Mons, 7000, Belgium

Location

Dr. Pierre-Dominique Ghislain, Mons, BE /ID# 154228

Mons, 7000, Belgium

Location

CHU UCL Namur /ID# 154223

Namur, 5000, Belgium

Location

CHU UCL Namur /ID# 154224

Namur, 5000, Belgium

Location

Ctr Hosp du Bois de l'Abbaye /ID# 154235

Seraing, 4100, Belgium

Location

Lecuyer, Thuin, Belgium /ID# 154229

Thuin, 6530, Belgium

Location

AZ Sint-Rembert Ziekenhuis /ID# 154231

Torhout, 8820, Belgium

Location

Centre Medical 4 sapins /ID# 154236

Wavre, 1300, Belgium

Location

Sanatorium, s.r.o /ID# 163593

Chotoviny, 391 32, Czechia

Location

Vojenska nemocnice /ID# 163592

Olomouc, 779 00, Czechia

Location

Kozni sanatorium /ID# 163591

Prague, 110 00, Czechia

Location

Kurzen, Freising, DE /ID# 153913

Freising, 85354, Germany

Location

University General Hospital Attikon /ID# 156761

Athens, Attica, 12462, Greece

Location

General Uni hosp of Larissa /ID# 156734

Larissa, Thessaly, 415 00, Greece

Location

Duplicate_General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens P /ID# 156762

Athens, 115 21, Greece

Location

251 Airforce General Hospital /ID# 156731

Athens, 11525, Greece

Location

Genl Hospital Andreas Syggros /ID# 156759

Athens, 16121, Greece

Location

Genl Hospital Andreas Syggros /ID# 156760

Athens, 16121, Greece

Location

University Gen Hosp of Patra /ID# 156735

Pátrai, 26504, Greece

Location

General Hospital of Thessaloni /ID# 156728

Thessaloniki, 55134, Greece

Location

General Hospital of Thessaloniki George Papanikolaou /ID# 156758

Thessaloniki, 57010, Greece

Location

401 GSNA - 401 Army Gen Hosp /ID# 156729

Αthens, 11525, Greece

Location

Miskolci Semmelweis Korhaz es /ID# 153175

Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary

Location

Pecsi Tudomanyegyetem /ID# 152612

Pécs, Pecs, 7624, Hungary

Location

Markusovszky Egyetemi Oktatókórház /ID# 152616

Szombathely, Vas County, 9700, Hungary

Location

Semmelweis Egyetem /ID# 152613

Budapest, 1085, Hungary

Location

Debreceni Egyetem Klinikai Központ /ID# 152615

Debrecen, 4032, Hungary

Location

Somogy Megyei Kaposi Mor Oktat /ID# 160782

Kaposvár, 7400, Hungary

Location

Bacs-Kiskun Megyei Korhaz /ID# 153180

Kecskemét, 6000, Hungary

Location

Szegedi Tudomanyegyetem /ID# 152614

Szeged, 6720, Hungary

Location

South Infirmary Victoria Univ /ID# 151095

Cork, Ireland

Location

St Vincent's University Hosp /ID# 151084

Dublin, D04 T6F4, Ireland

Location

Adelaide and Meath Hosp,IE /ID# 151096

Dublin, Ireland

Location

Galway University Hospital /ID# 151097

Galway, H91 YR71, Ireland

Location

University Hospital Waterford /ID# 153191

Waterford, X91 ER8E, Ireland

Location

Rabin Medical Center /ID# 149530

Petakh Tikva, Tel Aviv, 4941492, Israel

Location

Tel Aviv Sourasky Medical Ctr /ID# 149528

Tel Aviv, Tel Aviv, 6423906, Israel

Location

HaEmek Medical Center /ID# 164387

Afula, 1834111, Israel

Location

Rambam Health Care Campus /ID# 149529

Haifa, 3109601, Israel

Location

Hadassah University Hospital /ID# 149532

Jerusalem, 91120, Israel

Location

Sheba Medical Center /ID# 149531

Ramat Gan, 5262100, Israel

Location

Rizk Hospital /ID# 166027

Beirut, 1100, Lebanon

Location

Saint Georges Hosp Med Cent /ID# 166024

Beirut, 1100, Lebanon

Location

American Uni of Beirut Med Cen /ID# 166026

Beirut, 1103, Lebanon

Location

Trad Hospital and Medical Cent /ID# 166025

Beirut, 1103, Lebanon

Location

C/O Hotel Dieu de France /ID# 166028

Beirut, Lebanon

Location

General Hospital Celje /ID# 164673

Celje, 3000, Slovenia

Location

Univ Medical Ctr Ljubljana /ID# 164671

Ljubljana, 1000, Slovenia

Location

University Medical Ctr Maribor /ID# 164672

Maribor, 2000, Slovenia

Location

GH Novo Mesto /ID# 164674

Novo Mesto, 8000, Slovenia

Location

Hopitaux Universitaires de Geneve /ID# 160090

Geneva, Canton of Geneva, 1205, Switzerland

Location

Inselspital, Universitaetsklinik /ID# 160089

Bern, 3010, Switzerland

Location

University Hospital Zurich /ID# 160091

Zurich, 8091, Switzerland

Location

Marmara University Med Faculty /ID# 157903

Istanbul, 34662, Turkey (Türkiye)

Location

Whipps Cross Univ Hospital /ID# 150195

London, London, City of, E11 1NR, United Kingdom

Location

NHS Lanakshire (Monklands) /ID# 152885

Airdire, ML6 0JS, United Kingdom

Location

Belfast City Hospital /ID# 168411

Belfast, BT9 7AB, United Kingdom

Location

Univ Hospitals Birmingham NHS Foundation trust /ID# 152884

Birmingham, B15 2TG, United Kingdom

Location

Heartlands Hospital /ID# 168409

Birmingham, B9 5SS, United Kingdom

Location

Ninewells Hospital /ID# 168410

Dundee, DD1 9SY, United Kingdom

Location

Hull and East Yorkshire NHS /ID# 168413

Hull, HU8 9HE, United Kingdom

Location

St. James University Hospital /ID# 150200

Leeds, LS9 7TF, United Kingdom

Location

St. John's Institute of Dermat /ID# 150197

London, SE1 9RT, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 150199

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Norfolk and Norwich Univ Hosp /ID# 168412

Norwich, NR4 7UY, United Kingdom

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: July 5, 2016
• Primary Completion: January 7, 2019
• Study Completion: January 7, 2019
• Last Updated: January 9, 2020

Record last verified: 2019-09

Locations

BE (23); IE (5); HU (8); LE (5); CH (3); GB (11); GR (10); CZ (3); AU (3); DE (1); IL (6); SL (4); TU (1)