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Hidradenitis SuppurativaHARMONYNCT02786576

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

An observational study of Hidradenitis Suppurativa, run by AbbVie at 83 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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'… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Hidradenitis Suppurativa
How many people
236 participants
Where
83 sitesin 13 countries
Study dates
5 Jul 2016to 7 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hidradenitis Suppurativa (HS) participants receiving adalimumab

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

83 sites in 13 countries.

83 sites in 13 countries

Belgium23 sites

  • CLIDERM Bruxelles /ID# 154232

    Anderlecht, 1070

  • PP Anderlecht /ID# 154230

    Anderlecht, 1070

  • CHIREC- City Clinic Louise /ID# 154227

    Brussels, 1000

  • ULB Erasme /ID# 154216

    Brussels, 1070

  • UZ Antwerp /ID# 154219

    Edegem, 2650

  • Boonen, Geel, BE /ID# 154233

    Geel, 2440

  • UZ Gent /ID# 154221

    Ghent, Oost-Vlaanderen, 9000

  • Coenen, Hasselt, BE /ID# 154234

    Hasselt, 3500

  • Polyclinique de Herstal /ID# 154226

    Herstal, 4040

  • UZ Brussel /ID# 154218

    Jette, Brussels Capital, 1090

  • Meuleman, Lede, BE /ID# 154238

    Lede, 9340

  • CHU de Liege /ID# 154220

    Liège, Liege, 4000

  • Grand Hopital de Charleroi /ID# 154222

    Loverval, 6280

  • Lanssens MD Maldegem BE /ID# 154237

    Maldegem, 9990

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

    Mons, 7000

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

    Mons, 7000

  • CHU UCL Namur /ID# 154223

    Namur, 5000

  • CHU UCL Namur /ID# 154224

    Namur, 5000

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

    Seraing, 4100

  • Lecuyer, Thuin, Belgium /ID# 154229

    Thuin, 6530

  • AZ Sint-Rembert Ziekenhuis /ID# 154231

    Torhout, 8820

  • Centre Medical 4 sapins /ID# 154236

    Wavre, 1300

  • Cliniques Universitaires Saint Luc /ID# 154217

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

United Kingdom11 sites

  • NHS Lanakshire (Monklands) /ID# 152885

    Airdire, ML6 0JS

  • Belfast City Hospital /ID# 168411

    Belfast, BT9 7AB

  • Univ Hospitals Birmingham NHS Foundation trust /ID# 152884

    Birmingham, B15 2TG

  • Heartlands Hospital /ID# 168409

    Birmingham, B9 5SS

  • Ninewells Hospital /ID# 168410

    Dundee, DD1 9SY

  • Hull and East Yorkshire NHS /ID# 168413

    Hull, HU8 9HE

  • St. James University Hospital /ID# 150200

    Leeds, LS9 7TF

  • Whipps Cross Univ Hospital /ID# 150195

    London, London, City of, E11 1NR

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

    London, SE1 9RT

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

    Newcastle upon Tyne, NE1 4LP

  • Norfolk and Norwich Univ Hosp /ID# 168412

    Norwich, NR4 7UY

Other trials in United Kingdom

Greece10 sites

  • University General Hospital Attikon /ID# 156761

    Athens, Attica, 12462

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

    Athens, 115 21

  • 251 Airforce General Hospital /ID# 156731

    Athens, 11525

  • Genl Hospital Andreas Syggros /ID# 156759

    Athens, 16121

  • Genl Hospital Andreas Syggros /ID# 156760

    Athens, 16121

  • General Uni hosp of Larissa /ID# 156734

    Larissa, Thessaly, 415 00

  • University Gen Hosp of Patra /ID# 156735

    Pátrai, 26504

  • General Hospital of Thessaloni /ID# 156728

    Thessaloniki, 55134

  • General Hospital of Thessaloniki George Papanikolaou /ID# 156758

    Thessaloniki, 57010

  • 401 GSNA - 401 Army Gen Hosp /ID# 156729

    Αthens, 11525

Other trials in Greece

Hungary8 sites

  • Semmelweis Egyetem /ID# 152613

    Budapest, 1085

  • Debreceni Egyetem Klinikai Központ /ID# 152615

    Debrecen, 4032

  • Somogy Megyei Kaposi Mor Oktat /ID# 160782

    Kaposvár, 7400

  • Bacs-Kiskun Megyei Korhaz /ID# 153180

    Kecskemét, 6000

  • Miskolci Semmelweis Korhaz es /ID# 153175

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Pecsi Tudomanyegyetem /ID# 152612

    Pécs, Pecs, 7624

  • Szegedi Tudomanyegyetem /ID# 152614

    Szeged, 6720

  • Markusovszky Egyetemi Oktatókórház /ID# 152616

    Szombathely, Vas County, 9700

Other trials in Hungary

Israel6 sites

  • HaEmek Medical Center /ID# 164387

    Afula, 1834111

  • Rambam Health Care Campus /ID# 149529

    Haifa, 3109601

  • Hadassah University Hospital /ID# 149532

    Jerusalem, 91120

  • Rabin Medical Center /ID# 149530

    Petakh Tikva, Tel Aviv, 4941492

  • Sheba Medical Center /ID# 149531

    Ramat Gan, 5262100

  • Tel Aviv Sourasky Medical Ctr /ID# 149528

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Ireland5 sites

  • South Infirmary Victoria Univ /ID# 151095

    Cork

  • St Vincent's University Hosp /ID# 151084

    Dublin, D04 T6F4

  • Adelaide and Meath Hosp,IE /ID# 151096

    Dublin

  • Galway University Hospital /ID# 151097

    Galway, H91 YR71

  • University Hospital Waterford /ID# 153191

    Waterford, X91 ER8E

Other trials in Ireland

Lebanon5 sites

  • Rizk Hospital /ID# 166027

    Beirut, 1100

  • Saint Georges Hosp Med Cent /ID# 166024

    Beirut, 1100

  • American Uni of Beirut Med Cen /ID# 166026

    Beirut, 1103

  • Trad Hospital and Medical Cent /ID# 166025

    Beirut, 1103

  • C/O Hotel Dieu de France /ID# 166028

    Beirut

Other trials in Lebanon

Slovenia4 sites

  • General Hospital Celje /ID# 164673

    Celje, 3000

  • Univ Medical Ctr Ljubljana /ID# 164671

    Ljubljana, 1000

  • University Medical Ctr Maribor /ID# 164672

    Maribor, 2000

  • GH Novo Mesto /ID# 164674

    Novo Mesto, 8000

Other trials in Slovenia

Austria3 sites

  • LKH-Univ. Klinikum Graz /ID# 166802

    Graz, 8036

  • Krankenanstalt Rudolfstiftung /ID# 166804

    Vienna, State of Vienna, 1030

  • Klinikum Wels - Grieskirchen /ID# 158017

    Wels, 4600

Other trials in Austria

Czechia3 sites

  • Sanatorium, s.r.o /ID# 163593

    Chotoviny, 391 32

  • Vojenska nemocnice /ID# 163592

    Olomouc, 779 00

  • Kozni sanatorium /ID# 163591

    Prague, 110 00

Other trials in Czechia

Switzerland3 sites

  • Inselspital, Universitaetsklinik /ID# 160089

    Bern, 3010

  • Hopitaux Universitaires de Geneve /ID# 160090

    Geneva, Canton of Geneva, 1205

  • University Hospital Zurich /ID# 160091

    Zurich, 8091

Other trials in Switzerland

Germany1 site

  • Kurzen, Freising, DE /ID# 153913

    Freising, 85354

Other trials in Germany

Turkey (Türkiye)1 site

  • Marmara University Med Faculty /ID# 157903

    Istanbul, 34662

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Keywords
Moderate to Severe Hidradenitis Suppurativa, Adalimumab
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02786576
Study groupRoleWhat they receive
Participants receiving adalimumabHidradenitis Suppurativa (HS) participants receiving adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: At Week 12

Secondary outcomes (2)

  1. 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)

    Measured: Up to week 52

  2. 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.

    Measured: From Week 0 to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study start5 Jul 2016
  3. Primary completion7 Jan 2019
  4. Study completion7 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02786576
Sponsor's protocol ID
P15-769
Acronym
HARMONY
Status last verified
Sep 2019
First submitted
26 May 2016
Last updated
9 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hidradenitis Suppurativa, run by AbbVie at 83 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in Belgium, United Kingdom, Greece, Hungary, Israel and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response (time frame: At Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02786576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.

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