Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2019
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Lebanon,  Slovenia,  Switzerland,  Turkey,  United Kingdom, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT02904902 - Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa Phase 3
Completed NCT03628924 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Not yet recruiting NCT05531747 - Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa N/A
Recruiting NCT06028230 - A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Completed NCT03275870 - Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa Phase 1/Phase 2
Completed NCT03248531 - A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa. Phase 2
Withdrawn NCT04100083 - Spironolactone for Hidradenitis Suppurativa Phase 4
Completed NCT00329823 - Etanercept in Hidradenitis Suppurativa Phase 2
Recruiting NCT05710393 - Hidradenitis - an Analysis of Genetic Traits and Linkages in Families
Completed NCT04019041 - A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa Phase 2
Completed NCT05286567 - A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa. Phase 1
Withdrawn NCT03929835 - Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa Phase 2
Terminated NCT04325607 - Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa N/A
Terminated NCT03238469 - Microwave Ablation in Mild Axillary Hidradenitis Suppurativa N/A
Completed NCT04449354 - HidraWear AX HS Study N/A
Recruiting NCT06123429 - Mindfulness in Hidradenitis Suppurativa N/A
Recruiting NCT05934825 - Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa Phase 1/Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT06046729 - A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2

External Links