Primary objective: 1. To evaluate the effect of ustekinumab in patients with moderate to severe hidradenitis suppurativa (Hurley II-III), measured by disease specific score systmes: Sartorius/HS-LASI and PGA 2. To evaluate possible changes in scores…
ID
Source
Brief title
Condition
- Skin appendage conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters:
• Number of patients with a clinical response to ustekinimab using the
Sartorius/HS-LASI score. Clinical response is defined as >50% improvement at
week 40.
• Number of patients with a clinical response to ustekinimab using the PGA.
Clinical response is defined as a score of 0 (no disease activity) or 1 (mild
disease activity).
• Number of patients with improved quality of life using the DLQI questionnaire
and improvement in pain score using the VAS. A meaningfull improvement is
defined as an improvement of the DLQI with at least 5 points and at least 50%
improvement on the VAS.
Secondary outcome
• The correlation between serum Interleukine 2 Receptor (sIL2R) and HS disease
activity measured by means of the Sartorius/HS-LASI score, PGA and CRP.
• The mean reduction in the serum inflammation parameter (CRP).
• The mean improvement of Skindex-29.
• Description of the histopathological characteristics of HS and the
histopathological differences before and after treatment by means of skin
biopsies. To evaluate if we can find an explanation for the cause of HS at RNA
levels.
• The percentual difference in clinical response between patients who have been
treated before with biologics (TNF-α non-responders) and patients who have
never been treated with biologics (bio-naive patients).
Background summary
Hidradenitis suppurativa, also known as acne inversa, is a chronic, often
debilitating disease primarily affecting the axillae, perineum, and
inframammary regions. Clinically, the disease often presents with tender
subcutaneous nodules beginning around puberty. The nodules may spontaneously
rupture or coalesce, forming painful, deep dermal abscesses. Eventually,
fibrosis and the formation of extensive sinus tracts may result. The location
of the lesions may lead to social embarrassment and the failure to seek medical
treatment. Therapies in the past have consisted of long-term antibiotics,
anti-androgens, and surgery. New treatments like tumor necrosis factor alfa
(TNF-α) inhibitors have given clinicians more options against this difficult
disease.
Study objective
Primary objective:
1. To evaluate the effect of ustekinumab in patients with moderate to severe
hidradenitis suppurativa (Hurley II-III), measured by disease specific score
systmes: Sartorius/HS-LASI and PGA
2. To evaluate possible changes in scores of patient reported outcome
quationnaires (DLQI, VAS)
Secondary objectives:
1. measurement of infectionparameters in the blood (CRP, WBC, neutrophils in
the blood)
2. To evaluate whether serum solubleIL2R (IL2R)is correlated to hidradenitis
disease activity
- to evaluate a possible association between baseline sIL2R levels and the
Hurley stage
-tot evaluate a possible association between sIL2R levels and the clinical
aspect of HS during treatment with ustekunimab
3. To describe the histopathological characteristics of patients with HS and
the possible changes in the histopathology after treatment with ustekinumab to
evaluate whether on RNA level there is an explanation for the development of HS.
4. To describe the improvement in quality of life using the Skindex-29
questionnaire.
5.To evaluate if there is a difference in efficacy of ustekinumab in patients
already treated with biologics (TNF-α non-responders) and patients never
treated with a biologic .
6. To evaluate inflammation parameters on gene-expression level in the blood.
Study design
this is a prospective 'proof of concept' study with one treatment arm.
Intervention
patients < 100 kg receive a 45 mg subcutaneous injection with ustekinumab and
patients > 100 kg a 90 mg subcutaneous injection with ustekinumab on week
0-4-16 and 28
Study burden and risks
On week 0-6-12-18-24-30-36-40 a total of 3 tubes of blood per visit are taken
(1 of 4 1/2 cc, 2 of 4 cc) to monitor effect and side effect(s) of
ustekinumab.
Furthermore we perform biopsies on week 0, 16 and 28 of lesional and healthy
skin for histopathologic and immunohistochemical research, to monitor (possible
differences in) effect before and after treatment.
On week 0-4-10-16-22-28-34-40-52 and 76 patients are asked to fill in
questionnaires to measure quality of life before and after ustekinumab
treatment. This will take 15-20 minutes at a time.
Risks associated with participation consist of side effects as described in the
patientinformationfolder pages 4-6.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Patient above 18 to 65 years old
Patient with hidradenitis suppurativa Hurley stage II-III
Failure on conventional therapy with topical and oral antibiotics or immunosuppresiva or surgical intervention or on previous TNF alpha therapy (is not obligatory)
Patient has to be able to fill in a dutch formulated questionnaire
Signed informed consent
Women of childbaring age should use contraception
Exclusion criteria
Patients unable to fill in the questionnaires (mentally or physically)
Pregnancy or breast feeding patients
Patients with an active (chronic) infection, e.g. hepatitis B or C, HIV, tuberculosis
History of malignancy in past 10 years, except a basal cell carcinoma
Patients with demyelinating disease
Heartfailure NYHA class III-IV
Patients with a known allergy/hypersensitivity reaction to ustekinumab or one of the preservatives
Vaccination with living virus/bacterium < 3 months before starting ustekinumab
Severe liver or kidney dysfunction > 1.5 times of the maximum allowable value
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002091-16-NL |
| CCMO | NL36169.042.11 |