Hidradenitis suppurativa MedDRA version: 14.1 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Anakinra
Pharmaceutical Form: Injection
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharm
Sponsors
University of Athens, Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • written informed consent provided by the patient; • age above 18 years; • diagnosis of HS; and • HS of Hurley II or III stage disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: • history of systemic lupus erythematosus, of rheumatoid arthritis of of seronegative inflammatory arthritis; • any prior administration of any type of anti-TNF therapy over the last six months; • administration of any live (attenuated) vaccine over the last 4 weeks; • history of recurrent vein thrombosis or embolism compatible with anti-cardiolipin syndrome; • any present or smoldering infection; • hepatic dysfunction defined as any value of transaminases, of ?-glutamyl transpeptidase or of bilirubin> 2 x upper normal limit; • history of haematological or solid tumor malignancy, arterial hypertension, liver cirrhosis, HIV infection, and hepatitis virus B or C infection • history of episodes mimicking demyelinating disorders or a definite diagnosis of multiple sclerosis • any creatinine value above 1.5 mg/dl • intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1mg/kg for the last three weeks; • neutropenia defined as <1000 neutrophils/mm3; and • pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The safety and efficacy of anakinra in patients with HS of Hurley II and III stage disease. ;Secondary Objective: The effect of anakinra in the ex vivo function of PBMCs of patients with HS. ;Primary end point(s): The safety and efficacy of anakinra in patients with HS of Hurley II and III stage disease. This will be defined by the differences of VAS, of severity scores and of DLQI between the two study groups over visits.;Timepoint(s) of evaluation of this end point: Weeks 0, 4, 8, 12, 16, 20 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The effect of anakinra in the ex vivo function of PBMCs of patients with HS. This will be defined by the differences of cytokines produced by PBMCs between the two study groups over visits;Timepoint(s) of evaluation of this end point: Weeks 0, 12 and 24 | — |
Countries
Greece
Contacts
Public ContactTheodora Kanni
University of Athens, Medical School
Outcome results
None listed