MedTrace Logo

Anakinra in Hidradenitis Suppurativa

NCT01558375 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-05-27

No results posted yet for this study

Summary

Aim of this double-blind, randomized, controlled clinical trial is to compare the safety and the efficacy of anakinra over placebo for the management of patients with hidradenitis suppurativa (HS) of Hurley II and Hurley III disease stage. Patients will be evaluated on subsequent follow-up visits. Two scores will be applied: disease activity as assessed in the protocol by the investigator; and Sartorius score. Primary efficacy endpoint will be the comparisons of visual analogue scores, of disease activity, of Sartorius score and of dermatology life quality index between the two groups of treatment over follow-up.

Conditions

Interventions

DRUG

Water for injection

Placebo syringes will contain 0.67ml of sterile water for injection. This will be injecteda daily for 12 weeks.

DRUG

Anakinra

Anakinra will be supplied in single use pre-filed glass syringes with 27-gauge needles. Anakinra syringe will contain 100mg of anakinra at a volume of 0.67 ml. This will be injected subcutaneously daily for 12 weeks.

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Evangelos J Giamarellos-Bourboulis, MD, PhD · University of Athens, Medical School, Greece

  • Dimitrios Rigopoulos, MD, PhD · University of Athens, Medical School, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01558375 on ClinicalTrials.gov