Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 101 for:    hidradenitis suppurativa
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786576
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date May 26, 2016
First Posted Date June 1, 2016
Last Update Posted Date January 9, 2020
Actual Study Start Date July 5, 2016
Actual Primary Completion Date January 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2016)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 26, 2016)
  • 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)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting
Official Title Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting - HARMONY Study
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hidradenitis Suppurativa (HS) participants receiving adalimumab
Condition Hidradenitis Suppurativa
Intervention Not Provided
Study Groups/Cohorts Participants receiving adalimumab
Hidradenitis Suppurativa (HS) participants receiving adalimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 13, 2018)
236
Original Estimated Enrollment
 (submitted: May 26, 2016)
400
Actual Study Completion Date January 7, 2019
Actual Primary Completion Date January 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   Czechia,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Lebanon,   Slovenia,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries Croatia
 
Administrative Information
NCT Number NCT02786576
Other Study ID Numbers P15-769
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date September 2019