erfelijke periodieke koortssyndromen (TRAPS, HIDS of crFMF) hereditary periodic fevers
Conditions
Interventions
Treatment with canakinumab (in double blind epoch canakinumab or placebo).
Sponsors
Novartis
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male or female patients at least 2 years of age. Patients >28 days but 10mg/L (normal CRP range *10 mg/L) at randomization.
Exclusion criteria
Exclusion criteria: * Use of the following therapies (within varying protocol defined timeframes, see also protocol page 28-29): Corticosteroids, anakinra, canakinumab, rilonacept, tocilizumab, TNF inhibitors, abatacept, tofacitinib, rituximab, leflunomide, thalidomide, cyclosporine, intravenous immunoglobulin, 6-merceptopurine, azathioprine, cyclophosphamide, or chlorambucil, , any other investigational biologics * Significant medical diseases, including but not limited to the following: a) History of organ transplantation b) Elevated ALT *3x ULN c) Elevated AST *3x ULN d) Increase in total bilirubin CTC Grade *2 e) Serious hepatic disorder (Child-Pugh scores B or C) f) Chronic Kidney Disease NKF stages *4 g) Thyroid disease h) Diagnosis of active peptic ulcer disease i) Coagulopathy j) Significant CNS effects including vertigo and dizziness * Any conditions or significant medical problems which immunocompromise the patient and/ or places the patient at unacceptable risk for immunomodulatory therapy, e.g. a) Absolute neutrophil count decreased as per CTC Grade *1 b) Thrombocytopenia CTC * Grade 1 c) Any active or recurrent bacterial, fungal (with exception of onychomycosis) or viral infection d) HIV, Hepatitis B or C e) Tuberculosis f) Requirement for administration of antibiotics against latent TB g) Clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty*s syndrome * Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician*s global assessment of disease activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| CRP, SAA, responders in Epoch 2 who maintain a clinically meaningful response when switched to canakinumab every 8 weeks compared to placebo in epoch 3. Adverse events. PK/PD. | — |
Countries
Netherlands
Outcome results
None listed