Treatment of Refractory Hemochromatosis Rheumatism by Anakinra: a Preliminary Phase II Study

• Status: Terminated
• Trial end date: 2018-09-04
• Target enrollment: 0
• Participant gender: All

Summary

Treatment of refractory hemochromatosis rheumatism by Anakinra. Prospective, multicenter, non-randomised, single-arm, open-label, phase II trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.