Anakinra (Kineret®) for a hereditary autoinflammatory disease with MEFV mutation and inflammasome activation.

Phase 1

• Conditions: hereditary autoinflammatory disease with MEFV mutation and inflammasome activation; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-004292-69-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-03
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Adult patients with a hereditary autoinflammatory syndrome and S242R MEFV mutation, manifesting active disease both clinically (cutaneous and articular inflammation) and biologically (increased acute phase reactants).
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 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Patients with underlying active infectious disorder, and/or visceral organ involvement constituting a potential risk according to the investigator, will be excluded
2.Treatment with biological agents (esp. TNF antagonists) is not allowed during the trial, they will be stopped as follows:
Infliximab therapy will be stopped at least 8 weeks, and adalimumab/Etanercept will be stopped at least 4 weeks prior to baseline visit and first treatment with Anakinra
3.Treatment with classical DMARDS (esp. methotrexate and cyclosporine) is not allowed during the trial and will be stopped at least 4 weeks prior to baseline/first treatment with Anakinra
4.Corticosteroids are not allowed except for low-dose corticosteroids (<= 10mg prednisone equivalent daily) which can be kept stable during the trial.
5.Pregnant or breastfeeding women.
6.Participation in any clinical trial investigation within 4 weeks prior to dosing or longer if
required by local regulation.
7.Positive test for or prior history of HIV (ELISA and Western blot), Hepatitis B (Hepatitis B surface antigen) or Hepatitis C.
8.Presence of active infections or a history of pulmonary TB infection with or without
documented adequate therapy. Subjects with current active TB, or recent close exposure to an individual with active TB are excluded from the study.
9.Treatment with a live virus vaccine during 3 months prior to baseline visit. No live vaccines were allowed throughout the course of this study and up to 3 months following the last dose.
10.History of malignancy except for treated basal cell carcinoma
11.History of recurrent and/or evidence of active bacterial, fungal or viral infection(s).
12.Presence of any of the following laboratory abnormalities: ALT or AST greater than 2 times the upper limit of normal (ULN), platelet count less than 100x109/L.
13.Patients with neutropenia (absolute neutrophil count [ANC] < 1.5 x 109/l)
14.History of significant medical conditions, which in the investigator’s opinion would exclude the patient from participating in this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified