Adult-Onset Still's Disease Clinical Trial
Official title:
An Open, Randomized Study Treating Refractory Adult-onset Still's Disease With Interleukin-1 Receptor Antagonist Anakinra (Kineret), Compared to an Established, Single Anti-rheumatic Drug Treatment
An open, randomized, parallel-group, comparative, multicentre study. Patients on
corticosteroids (plus conventional therapy) will be randomized to receive anakinra
(Kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin A
or sulphasalazine. Patients enter the study if considered refractory to corticosteroids
(prednisolone equivalent ≥10 mg/day) at the time of randomization.
The randomized phase of the study will be followed by an open-label extension (OLE) phase,
to follow-up drug survival, efficacy, tolerability and disease-related parameters of
long-term treatment with anakinra or one of the study DMARDs or a combination of study drugs
for additional 28 weeks.
Product: Kineret (anakinra) Comparative agents: Methotrexate or azathioprine or leflunomide
or cyclosporin A or sulphasalazine Protocol title: An open, randomized study treating
refractory adult-onset Still's disease with IL-1ra anakinra (Kineret, compared to an
established, single anti-rheumatic treatment Target Disease: Adult-onset Still's disease
Patients: 23 patients diagnosed with AOSD, living in the four Nordic countries.
Study Objectives: To follow the changes in clinical status and disease activity in patients
receiving anakinra, compared to those treated with an established DMARD, in addition to
corticosteroids in patients with refractory AOSD. To compare the changes in disease-related
parameters (global health, patient's assessment on disease, laboratory values) in the two
randomized groups. To assess the safety of anakinra in AOSD. To follow-up drug survival,
efficacy, tolerability and disease-related parameters of long-term treatment in AOSD (open
phase).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT05432960 -
Efficacy and Safety Clinical Study of RPH-104 in Adult Onset Still's Disease (AOSD)
|
Phase 3 |