drugset / Trial / NCT01033656
Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study
Phase 2
Completed
23 enrolled
University of Helsinki
Helse Stavanger HF · collabJyväskylä Central Hospital · collabKuopio University Hospital · collabOulu University Hospital · collabSatakunta Central Hospital · collabTampere University Hospital · collabTurku University Hospital · collabUniversity Hospital, Linkoeping · collabUniversity Hospital, Umeå · collabUppsala University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2005-12
- Primary completion
- 2010-03
- Completion
- 2010-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |
| Comparator | Azathioprine | Small molecule | — | Oral |
| Comparator | Cyclosporine | Peptide | — | Oral |
| Comparator | Leflunomide | Small molecule | — | Oral |
| Comparator | Methotrexate | Small molecule | — | Oral |
| Comparator | Sulfasalazine | Small molecule | — | Oral |