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Etanercept for Treatment of Hidradenitis

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ClinicalTrials.gov Identifier: NCT00107991
Recruitment Status : Completed
First Posted : April 12, 2005
Results First Posted : January 14, 2011
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Gelfand, University of Pennsylvania

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hidradenitis Suppurativa
Intervention Drug: etanercept
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept
Hide Arm/Group Description 50 mg/week subcutaneously
Period Title: Eligibility Assessment
Started 38
Completed 15
Not Completed 23
Reason Not Completed
Disease not severe enough             7
Unwilling to participate             7
Positive purified protein derivative             4
Abnormal labs             2
Ongoing treatment with antibiotics             1
chronic uncontrolled asthma             1
hx of alcohol abuse in past 12 months             1
Period Title: 12 Week Treatment Period
Started 15
Completed 10
Not Completed 5
Reason Not Completed
Lack of Efficacy             2
Adverse Event             1
Protocol Violation             1
Incarcerated             1
Period Title: 18-Week Post Treatment Assessment
Started 10
Completed 8
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Etanercept
Hide Arm/Group Description 50 mg/week subcutaneously
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants
45
(30 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
13
  86.7%
Male
2
  13.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  20.0%
White
12
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Dermatology Life Quality Index (DLQI)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
19
(14 to 29)
[1]
Measure Description: The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large
Physician's Global Assessment Score (PGA)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
4.35
(3.1 to 4.8)
[1]
Measure Description: PGA score on a 100 mm visual analog scale, with 0 mm corresponding to no active disease and 100 mm corresponding to very severe disease with multiple, painful inflammatory lesions.
No. of lesions   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Lesions
Number Analyzed 15 participants
14
(8 to 19)
[1]
Measure Description: numbers of lesions (nodules and abscesses) as assessed by a physician
Patient Pain Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
6.4
(4.5 to 7.4)
[1]
Measure Description: Patient self-report of pain on a 100-mm visual analog scale with 0 corresponding to no pain and 100 mm corresponding to severe pain
Duration of disease   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
12
(1 to 36)
[1]
Measure Description: Duration of time patient had hidradenitis suppurativa prior to trial (in years)
Prior systemic and intralesional therapies  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants
Oral antibiotics 14
Accutane 9
Surgery 8
Intralesional corticosteroids 3
Oral contraceptives 2
Oral corticosteroids 1
Injected antibiotics 1
Ketoconazole 1
Nicomide 1
Spironolactone 1
Cimetidine 1
BMI   [1] 
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants
35.1
(17.9 to 47.5)
[1]
Measure Description: Body mass index in kg/meters squared
1.Primary Outcome
Title 50% Reduction in Physician's Global Assessment Score (Percent of Participants)
Hide Description

Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks.

PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
50 mg/week subcutaneously
Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20
(4.3 to 48.1)
2.Secondary Outcome
Title 50% Reduction in Number of Lesions (Percent of Participants)
Hide Description A physician assessed number of lesions as baseline and week 12. Responders were defined as those achieving at least a 50% reduction in number of lesions. A response rate was calculated as percentage of patients classified as responders.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
50 mg/week subcutaneously
Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.3
(1.66 to 40.5)
3.Secondary Outcome
Title Patient Global Assessment
Hide Description

The Patient Global Assessment asked patients to rate the extent of hidradenitis activity compared to when the patient started treatment with etanercept (day 0 of study). The scale included a selection of:

Much worse than before treatment Moderately worse (about 50% more disease activity) A little worse Same A little improved Moderately improved (about 50% reduction in disease activity) Much better than before treatment (no active disease or almost no active disease)

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
50 mg/week subcutaneously
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Much worse 0
Moderately worse (~50% more disease activity) 3
A little worse 1
Same 2
A little improved 4
Moderately improved (~50% reduction in disease) 4
Much better (almost no active disease) 0
4.Secondary Outcome
Title Patient's Pain Score
Hide Description Patient's were asked to self-report their pain on a 100-mm visual analog scale (with 0 corresponding to no pain and 100 mm corresponding to severe pain). Responders were defined as those achieving at least a 50% reduction in pain score from baseline to week 12. Response rate was calculated as the percentage of patients classified as responders.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
50 mg/week subcutaneously
Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Response Rate - % of participants
26.7
(7.8 to 55.1)
5.Secondary Outcome
Title Dermatology Life Quality Index Score (DLQI)
Hide Description

The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large. Responders were defined as those who achieved a 50% improvement in the DLQI score.

Response rates were calculated as the percentage of participants achieving a response.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept
Hide Arm/Group Description:
50 mg/week subcutaneously
Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Response Rate - % of participants
20
(4.3 to 48.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept
Hide Arm/Group Description 50 mg/week subcutaneously
All-Cause Mortality
Etanercept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etanercept
Affected / at Risk (%)
Total   14/15 (93.33%) 
Gastrointestinal disorders   
Nausea   3/15 (20.00%) 
Infections and infestations   
Flu-like symptoms   1/15 (6.67%) 
Metabolism and nutrition disorders   
Elevated cholesterol   1/15 (6.67%) 
Musculoskeletal and connective tissue disorders   
Muscle cramps   1/15 (6.67%) 
Nervous system disorders   
Paresthesias   2/15 (13.33%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract infection   4/15 (26.67%) 
Chest pain   1/15 (6.67%) 
Skin and subcutaneous tissue disorders   
Injection site erythema, bruising, or irritation   2/15 (13.33%) 
Cellulitis   2/15 (13.33%) 
Vascular disorders   
Hypertension   1/15 (6.67%) 
Indicates events were collected by systematic assessment
This study did not have a control group, and therefore, it is possible that observed benefits could be as a result of natural remission or a placebo effect.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Goldfarb
Organization: UPenn
Phone: 215-662-2540
EMail: jennifer.goldfarb@uphs.upenn.edu
Layout table for additonal information
Responsible Party: Joel Gelfand, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00107991     History of Changes
Other Study ID Numbers: 802687
0305
First Submitted: April 11, 2005
First Posted: April 12, 2005
Results First Submitted: January 4, 2011
Results First Posted: January 14, 2011
Last Update Posted: March 21, 2018