TREATMENT OF HIDRADENITIS SUPPURATIVE WITH ANAKINRA

Conditions: Hidradenitis suppurativa
MedDRA version: 14.1Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-005145-12-GR

Lead Sponsor: niversity of Athens, Medical School

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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