Status:
TERMINATED
Treatment of Refractory Hemochromatosis Rheumatism by Anakinra: a Preliminary Phase II Study
Lead Sponsor:
Rennes University Hospital
Conditions:
Refractory Hemochromatosis Rheumatism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Treatment of refractory hemochromatosis rheumatism by Anakinra. Prospective, multicenter, non-randomised, single-arm, open-label, phase II trial.
Detailed Description
Hereditary hemochromatosis (HH) is a genetic disease characterized by tissue iron overload. The most common genotype is homozygosity for the p.Cys282Tyr mutation of the HFE gene (MIM 235200). It is a ...
Eligibility Criteria
Inclusion
- Patients with age equal to or over 18 years old,
- Patients with proved hereditary hemochromatosis with homozygosity for the C282Y mutation of the HFE gene,
- Patients with rheumatism related to hemochromatosis, considered by the rheumatologist refractory to usual treatment defined by a persistent painful symptomatology despite a treatment of at least one month with level 2 analgesics (weak opioids) at maximal dose, NSAID, colchicine, steroid injection or a combination of these treatments,
- Patients with pain \> 40/100mm measured by VAS (pain of the last 48 hours),
- Effective contraception to be used during treatment and until 48h after the last administration for women of reproductive age,
- Patients who have given written informed consent.
Exclusion
- Other cause of inflammatory rheumatisms such as Rheumatoid Arthritis, Spondyloarthropathies, psoriatic arthritis, or systemic diseases,
- Ongoing treatment with Methotrexate, Hydroxychloroquine, biologic or immunosuppressive drugs
- Malignant pathology, monoclonal gammopathy,
- Intolerance to anakinra,
- Contraindications to the use of anakinra: pregnancy or breastfeeding, hypersensitivity to any of the excipients or to proteins from E. coli, severe renal impairment (creatinine clearance \<30 ml / minute), neutropenia (neutrophil count \<1.5 x 109 / l), ongoing infection
- Patients that cannot follow the protocol,
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
Key Trial Info
Start Date :
February 4 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02263638
Start Date
February 4 2015
End Date
September 4 2018
Last Update
March 12 2019
Active Locations (3)
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1
CHRU de Lille
Lille, France
2
Groupe Hospitalier Lariboisière
Paris, France
3
Rennes University Hospital
Rennes, France, 35033