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A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa (HiTS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704534
First Posted: October 11, 2012
Last Update Posted: February 13, 2015
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.
Collaborator:
Janssen-Cilag B.V.
Information provided by (Responsible Party):
Barbara Horváth, Principal Investigator, University Medical Centre Groningen
  Purpose
The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.

Condition Intervention Phase
Hidradenitis Suppurativa Drug: Ustekinumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)

Resource links provided by NLM:


Further study details as provided by Barbara Horváth, Principal Investigator, University Medical Centre Groningen:

Primary Outcome Measures:
  • Change in Sartorius score [ Time Frame: 76 weeks ]
    Clinical response is defined as an improvement of the Sartorius score of at least 50%


Enrollment: 20
Study Start Date: May 2012
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ustekinumab
Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28
Drug: Ustekinumab
subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28
Other Name: Stelara

Detailed Description:
An open label prospective study is performed to investigate the effectiveness and safety of ustekinumab in hidradenitis suppurativa. Twenty patients will be included. They will receive ustekinumab 45 or 90 mg on weeks 0-4-16-28. Patients will be followed up untill week 40.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Hidradenitis suppurativa Hurley stage II or III
  • No response to conventional local and oral antibiotics, or immunnesuppressive medication, or TNF-alpha inhibitors or surgery
  • The patient has to be able to complete a dutch questionnaire
  • Informed consent must be obtained

Exclusion Criteria:

  • Not able to complete a Dutch questionnaire
  • Pregnancy or breast feeding
  • Active hepatitis B or C infection, HIV or tuberculosis
  • Treatment with biologics or other immunosuppressive medicine in the previous 3 months
  • Malignancies in the last 10 years with the exception of basal cell carcinoma
  • Demyelinating disorders
  • Heart failure
  • Known allergy to ustekinumab or to its preservatives
  • Live vaccins in the next 3 months Sever liver or renal failure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704534


Locations
Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
Janssen-Cilag B.V.
Investigators
Principal Investigator: Barbara Horváth, MD-PhD University Medical Center Groningen
  More Information

Responsible Party: Barbara Horváth, Principal Investigator, MD PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01704534     History of Changes
Other Study ID Numbers: 662507
2011-002091-16 ( EudraCT Number )
First Submitted: August 7, 2012
First Posted: October 11, 2012
Last Update Posted: February 13, 2015
Last Verified: February 2015

Keywords provided by Barbara Horváth, Principal Investigator, University Medical Centre Groningen:
Hidradenitis suppurativa
Acne ectopica
Inverse acne
Ustekinumab
Stelara

Additional relevant MeSH terms:
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Ustekinumab
Dermatologic Agents