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

January 6, 2020 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • LKH-Univ. Klinikum Graz /ID# 166802
      • Wels, Austria, 4600
        • Klinikum Wels - Grieskirchen /ID# 158017
    • Wien
      • Vienna, Wien, Austria, 1030
        • Krankenanstalt Rudolfstiftung /ID# 166804
  • Belgium
      • Anderlecht, Belgium, 1070
        • CLIDERM Bruxelles /ID# 154232
      • Anderlecht, Belgium, 1070
        • PP Anderlecht /ID# 154230
      • Brussels, Belgium, 1000
        • CHIREC- City Clinic Louise /ID# 154227
      • Brussels, Belgium, 1070
        • ULB Erasme /ID# 154216
      • Edegem, Belgium, 2650
        • UZ Antwerp /ID# 154219
      • Geel, Belgium, 2440
        • Boonen, Geel, BE /ID# 154233
      • Hasselt, Belgium, 3500
        • Coenen, Hasselt, BE /ID# 154234
      • Herstal, Belgium, 4040
        • Polyclinique de Herstal /ID# 154226
      • Lede, Belgium, 9340
        • Meuleman, Lede, BE /ID# 154238
      • Loverval, Belgium, 6280
        • Grand Hopital de Charleroi /ID# 154222
      • Maldegem, Belgium, 9990
        • Lanssens MD Maldegem BE /ID# 154237
      • Mons, Belgium, 7000
        • C.H.U.de Mons Borinage /ID# 154215
      • Mons, Belgium, 7000
        • Dr. Pierre-Dominique Ghislain, Mons, BE /ID# 154228
      • Namur, Belgium, 5000
        • CHU UCL Namur /ID# 154223
      • Namur, Belgium, 5000
        • CHU UCL Namur /ID# 154224
      • Seraing, Belgium, 4100
        • Ctr Hosp du Bois de l'Abbaye /ID# 154235
      • Thuin, Belgium, 6530
        • Lecuyer, Thuin, Belgium /ID# 154229
      • Torhout, Belgium, 8820
        • AZ Sint-Rembert Ziekenhuis /ID# 154231
      • Wavre, Belgium, 1300
        • Centre Medical 4 sapins /ID# 154236
    • Bruxelles-Capitale
      • Jette, Bruxelles-Capitale, Belgium, 1090
        • UZ Brussel /ID# 154218
      • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
        • Cliniques Universitaires Saint Luc /ID# 154217
    • Liege
      • Liège, Liege, Belgium, 4000
        • CHU de Liege /ID# 154220
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 154221
  • Czechia
      • Chotoviny, Czechia, 391 32
        • Sanatorium, s.r.o /ID# 163593
      • Olomouc, Czechia, 779 00
        • Vojenska nemocnice /ID# 163592
      • Praha, Czechia, 110 00
        • Kozni sanatorium /ID# 163591
  • Germany
      • Freising, Germany, 85354
        • Kurzen, Freising, DE /ID# 153913
  • Greece
      • Athens, Greece, 115 21
        • Duplicate_General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens P /ID# 156762
      • Athens, Greece, 11525
        • 251 Airforce General Hospital /ID# 156731
      • Athens, Greece, 16121
        • Genl Hospital Andreas Syggros /ID# 156759
      • Athens, Greece, 16121
        • Genl Hospital Andreas Syggros /ID# 156760
      • Patras, Greece, 26504
        • University Gen Hosp of Patra /ID# 156735
      • Thessaloniki, Greece, 55134
        • General Hospital of Thessaloni /ID# 156728
      • Thessaloniki, Greece, 57010
        • General Hospital of Thessaloniki George Papanikolaou /ID# 156758
      • Αthens, Greece, 11525
        • 401 GSNA - 401 Army Gen Hosp /ID# 156729
    • Attiki
      • Athens, Attiki, Greece, 12462
        • University General Hospital Attikon /ID# 156761
    • Thessalia
      • Larissa, Thessalia, Greece, 415 00
        • General Uni hosp of Larissa /ID# 156734
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 152613
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Központ /ID# 152615
      • Kaposvár, Hungary, 7400
        • Somogy Megyei Kaposi Mor Oktat /ID# 160782
      • Kecskemét, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz /ID# 153180
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem /ID# 152614
    • Borsod-Abauj-Zemplen
      • Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
        • Miskolci Semmelweis Korhaz es /ID# 153175
    • Pecs
      • Pécs, Pecs, Hungary, 7624
        • Pecsi Tudomanyegyetem /ID# 152612
    • Vas
      • Szombathely, Vas, Hungary, 9700
        • Markusovszky Egyetemi Oktatókórház /ID# 152616
  • Ireland
      • Cork, Ireland
        • South Infirmary Victoria Univ /ID# 151095
      • Dublin, Ireland, D04 T6F4
        • St Vincent's University Hosp /ID# 151084
      • Dublin 24, Ireland
        • Adelaide and Meath Hosp,IE /ID# 151096
      • Galway, Ireland, H91 YR71
        • Galway University Hospital /ID# 151097
      • Waterford, Ireland, X91 ER8E
        • University Hospital Waterford /ID# 153191
  • Israel
      • Afula, Israel, 1834111
        • HaEmek Medical Center /ID# 164387
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 149529
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital /ID# 149532
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center /ID# 149531
    • Tel-Aviv
      • Petakh Tikva, Tel-Aviv, Israel, 4941492
        • Rabin Medical Center /ID# 149530
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Ctr /ID# 149528
  • Lebanon
      • Beirut, Lebanon, 1100
        • Rizk Hospital /ID# 166027
      • Beirut, Lebanon, 1100
        • Saint Georges Hosp Med Cent /ID# 166024
      • Beirut, Lebanon, 1103
        • American Uni of Beirut Med Cen /ID# 166026
      • Beirut, Lebanon, 1103
        • Trad Hospital and Medical Cent /ID# 166025
      • Beirut, Lebanon
        • C/O Hotel Dieu de France /ID# 166028
  • Slovenia
      • Celje, Slovenia, 3000
        • General Hospital Celje /ID# 164673
      • Ljubljana, Slovenia, 1000
        • Univ Medical Ctr Ljubljana /ID# 164671
      • Maribor, Slovenia, 2000
        • University Medical Ctr Maribor /ID# 164672
      • Novo Mesto, Slovenia, 8000
        • GH Novo Mesto /ID# 164674
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitaetsklinik /ID# 160089
      • Zurich, Switzerland, 8091
        • University Hospital Zurich /ID# 160091
    • Geneve
      • Genève, Geneve, Switzerland, 1205
        • Hopitaux Universitaires de Geneve /ID# 160090
  • Turkey
      • Istanbul, Turkey, 34662
        • Marmara University Med Faculty /ID# 157903
  • United Kingdom
      • Airdire, United Kingdom, ML6 0JS
        • NHS Lanakshire (Monklands) /ID# 152885
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital /ID# 168411
      • Birmingham, United Kingdom, B15 2TG
        • Univ Hospitals Birmingham NHS Foundation trust /ID# 152884
      • Birmingham, United Kingdom, B9 5SS
        • Heartlands Hospital /ID# 168409
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital /ID# 168410
      • Hull, United Kingdom, HU8 9HE
        • Hull and East Yorkshire NHS /ID# 168413
      • Leeds, United Kingdom, LS9 7TF
        • St. James University Hospital /ID# 150200
      • London, United Kingdom, SE1 9RT
        • St. John's Institute of Dermat /ID# 150197
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 150199
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich Univ Hosp /ID# 168412
    • London, City Of
      • London, London, City Of, United Kingdom, E11 1NR
        • Whipps Cross Univ Hospital /ID# 150195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hidradenitis Suppurativa (HS) participants receiving adalimumab

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Participants receiving adalimumab
Hidradenitis Suppurativa (HS) participants receiving adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response
Time Frame: At Week 12
Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)
At Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with moderate to severe HS who achieve a clinical response
Time Frame: Up to week 52
Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)
Up to week 52
Changes from baseline in Dermatology Quality of Life Index (DLQI)
Time Frame: 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.
From Week 0 to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2016

Primary Completion (Actual)

January 7, 2019

Study Completion (Actual)

January 7, 2019

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-769

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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