A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa
NCT ID: NCT01704534
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2012-05-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ustekinumab
Ustekinumab 45 mg or 90 mg (dependent on patient's weight) administered on weeks 0-4-16-28
Ustekinumab
subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28
Interventions
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Ustekinumab
subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Janssen-Cilag B.V.
INDUSTRY
University Medical Center Groningen
OTHER
Responsible Party
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Principal Investigators
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Barbara Horváth, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Centre Groningen
Groningen, , Netherlands
Countries
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Other Identifiers
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2011-002091-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
662507
Identifier Type: -
Identifier Source: org_study_id
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