Hidradenitis suppurativa is defined as a chronic inflammatory disease of the intertriginous area, including the axilla, groin and anogenital or submammary regions. The condition is characterized by inflammation, recurrent abscesses, fistulas and sinus tracts, leading to post-inflammatory contracture and accordion-like mutilating scars. Mostly this disease appears in younger patients from 15 - 45 years and is connected with a high burden of disease and decreased quality of life.
Conditions
Interventions
Trade Name: HUMIRA
Product Name: HUMIRA
Pharmaceutical Form: Solution for injection in pre-filled syringe
Sponsors
University Hospital Frankfurt for its Dermatology Department, Clinical Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria • Diagnosis of HS for minimum of six months • Disease state diagnosed to be active and moderate to severe HS, requiring systemic therapy • No severe or otherwise clinically significant abnormalities found within the patient’s medical/medication history, nor during physical examination • Minimum of one previously failed or insufficiently responded to systemic therapy for HS • Women of childbearing age who are sexually active must use a highly effective form of contraception (Pearl Index =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main exclusion criteria • Previous use of Adalimumab (Humira®) or any other TNF-a inhibitors Exclusion criteria related to IMP • According to SmPC • According to approval status of EMA • According to approval status of Adalimumab for treatement of HS in Germany • Known hypersensitivity to any component of the IMP Exclusion criteria related to general health • Active dermatologic conditions that may confound the diagnosis of HS or would interfere with the assessment of treatment (e.g., atopic dermatitis, seborrhoic dermatitis, ichthyosis, psoriasis vulgaris, folliculitis) • History of a clinically significant infection four weeks prior to baseline visit, which, in the opinion of the investigator, may compromise the safety of the subject • History of chronic alcohol/drug abuse within the last 12 months before screening • Pregnant or breastfeeding women • Severe kidney insufficiency (GFR < 30 ml/min) • Any severe diseases that may, in the opinion of the investigator, interfere or worsen the hidradenitis suppurativa or result in safety concerns for patients being treated with an anti-TNF-alpha Inhibitor • History or presence of human immunodeficiency virus (HIV), and/or hepatitis B (HBV) or C virus (HCV) infections • History of active tuberculosis (TB), or untreated or inadequately treated latent TB (LTBI). Subjects must have a negative QuantiFERON, T-SPOT, or purified protein derivative (PPD) test, performed less than three months before the screening visit. • Any active medication which suppresses the immune system • History, current signs, symptoms, or diagnosis of a demyelinating disorder • History of or current Class III or IV congestive heart failure, as defined by the New York Heart Association, • History or current signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma • Current malignancy or history of any malignancy, except for adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ; no more than a total of three lifetime basal cell or squamous cell carcinomas permitted • Concurrent enrolment in another clinical trial, in which the subject is receiving an investigational product • Any major surgery in the last four weeks, that in the opinion of investigator, study related procedures or treatment with an anti-TNF-alpha inhibitor is contraindicated. • Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease, including pleural effusions or ascites, which, in the opinion of the investigator pose an unacceptable safety risk • History of latex allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Considering that HS is a severe progressive disease that requires tight control and that might be under diagnosed, this prospective, open-label study provides a deeper view into the pathophysiological mechanism of HS and is furthermore aligned to detect potential biomarkers. Such biomarkers could allow researchers to predict early on whether anti-TNF-alpha treated patients will respond to anti-inflammatory therapy or not, even before clinical improvement can be seen. The Co-primary objective will be: • To analyze the pattern of inflammatory cytokines in patients with moderate-to-severe HS before treatment with a TNF-alpha antagonist. • To evaluate changes (quantitative) in the pattern of inflammatory cytokine expression in patients with moderate-to-severe HS, 2 and 6 weeks after initiation of an anti-TNF-alpha treatment. ;Secondary Objective: Furthermore clinical parameters should be evaluated after 2 and 6 weeks of treatment with adalimumab e.g. reduction of pain, reduction of itch, reduction of clinical parameters (clinical scores) and shroud be brought in connection with the clinical inflammatory pattern. ;Primary end point(s): • To analyze the pattern of inflammatory cytokines in patients with moderate-to-severe HS before treatment with a TNF-alpha antagonist. • To evaluate changes (quantitative) in the pattern of inflammatory cytokine expression in patients with moderate-to-severe HS, 2 and 6 weeks after initiation of an anti-TNF-alpha treatment. ;Timepoint(s) of evaluation of this end point: After 2 and 6 weeks go treatment with the TNF-alpha Inhibitor Adalimumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Evaluation of changes in HS severity, as assessed using the Hidradenitis Suppurativa Clinical Response Score (HiSCR), IHS4 Score (International Hidradenitis suppurativa 4), Modified sartorius score and HsPGA (Hidradenitis suppurativa physicians clinical assessment) at week 0, 2- and 6 will be determined. • Evaluation of subjective changes in pain on a VAS during 2- and 6-week courses of treatment with a TNF-alpha antagonist. • Evaluation of the subjects’ subjective changes in itching on a VAS during 2- and 6-week courses of treatment with a TNF-alpha antagonist. • Evaluation of the change in patients’ quality of life using the DLQI. ;Timepoint(s) of evaluation of this end point: After 2 and 6 weeks go treatment with the TNF-alpha Inhibitor Adalimumab. | — |
Countries
Germany
Contacts
Public ContactClinical Research KDVA
Dermatology Department, University Hospital Frankfurt
Outcome results
None listed