A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and… (NCT03265132) | Clinical Trial Compass
TerminatedPhase 3
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)
Stopped: Meeting enrolment target (81 pat) will not be feasible within reasonable time.
United States13 participantsStarted 2017-09-26
Plain-language summary
The aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset Still's disease).
Who can participate
SexALL
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Inclusion criteria
✓. Signed informed consent.
✓. Male and female patients with a body weight ≥ 10 kg.
✓. Diagnosis of Still's disease.
✓. If currently on glucocorticoid treatment, a stable dose for at least 1 week prior to randomization.
✓. If currently on methotrexate treatment, a stable dose for at least 8 weeks prior to randomization.
✓. Active disease.
✓. Female patients of childbearing potential must use an effective method of contraception during the study (abstinence being a possible option) as well as present a negative pregnancy test prior to randomization.
✓. Negative interferon-gamma release assay or Purified protein derivative ( PPD) test within 2 months prior to randomization. If not available, a test should be performed at day of randomization.
Exclusion criteria
✕. Diagnosis of Still's disease more than 6 months prior to randomization.
✕. Previous randomization into this study.
✕. Participation in another concurrent clinical interventional study within 30 days of randomization.
✕. Treatment with an investigational drug within 5 half-lives prior to randomization.
What they're measuring
1
Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.
. Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor.
✕. Use of the following therapies prior to randomization:
✕. Live vaccines within 1 month prior to randomization.
✕. Known presence or suspicion of active, chronic or recurrent bacterial, fungal or viral infections, including tuberculosis, HIV infection or hepatitis B or C infection.