Canakinumab for Treatment of Adult-onset Still's Disease
Condition: Adult-Onset Still´s Disease
MeSH terms: Arthritis, Juvenile; Still's Disease, Adult-Onset
Intervention: Canakinumab; Placebo
Intervention description: Canakinumab, single-dose 4 mg/kg up to 300 mg administered subcutaneously.; Matching placebo administered subcutaneously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Adult-Onset Still´s Disease; Canakinumab; Joint involvement; AOSD

Summary:

      The purpose of this trial is to investigate the efficacy of the treatment with canakinumab in
      participants with Adult-onset Still's Disease (AOSD) and active joint involvement.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written and signed consent from the participant to take part in the study

          2. Men and women aged ≥ 18 years and ≤ 75 years

          3. Fulfilment of AOSD classification criteria (according to Yamaguchi et al, J.
             Rheumatology, 1992)

          4. Disease activity based on Disease Activity Score 28 (DAS28) of ≥3.2 at screening

          5. At least 4 painful and 4 swollen joints at screening and baseline (of the 28 joints
             according to DAS28)

          6. If undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), stable
             dose for at least 4 weeks prior to randomisation

          7. If undergoing treatment with glucocorticoids, stable dose of ≤10 milligrams per day
             (mg/day) (prednisolone or equivalent) for at least 4 weeks prior to randomisation

          8. If undergoing treatment with conventional disease-modifying anti-rheumatic drugs
             (DMARD), stable dose for at least 3 months prior to randomisation

          9. Normalisation period for biological DMARDS (anakinra 1 week, etanercept 1 month,
             adalimumab and certolizumab 2 months, infliximab, golimumab, abatacept and tocilizumab
             3 months, rituximab 9 months, canakinumab 6 months) prior to randomisation

         10. In participants of reproductive age, use of an effective method of contraception as
             well as negative pregnancy test prior to the study commencing.

        Exclusion Criteria:

          1. Previous treatment with the study drug with repeated administration of canakinumab

          2. Intraarticular or intravenous administration of glucocorticoids within 4 weeks prior
             to the baseline or use of narcotic analgesics except for analgesics permitted within
             the framework of the investigation (codeine and tramadol)

          3. Presence of another, serious chronic-inflammatory disease

          4. Positive hepatitis B antigen (HBsAg), hepatitis C antibodies and/or human
             immunodeficiency virus (HIV) antibodies.

          5. Presence of a relevant, active infection or other diseases, which entail a tendency
             towards infection

          6. Positive screening for latent tuberculosis, in accordance with usual local practice

          7. Raised liver count (raised bilirubin; alanine aminotransferase (ALT) or aspartate
             aminotransferase (AST) ≥ 3-fold the normal range)

          8. Serum-creatinine concentration >1.5 milligrams per deciliter (mg/dL)

          9. Inadequate haematological findings (hemoglobin [Hb] ≤ 10 grams per deciliter (g/dL),
             neutrophils ≤2,500/microliter (µl) and thrombocytes ≤100,000/µl)

         10. Simultaneous participation in any other interventional clinical study within the last
             30 days preceding the commencement of the study

         11. History of neoplasia with the exception of a curatively treated non-melanoma skin
             tumour or carcinoma of the cervix treated in situ without any indication of recurrence
             within the last 10 years

         12. Relevant cardiac or pulmonary disorders

         13. Severe intercurrent neurological or psychiatric disorders

         14. Macrophage activation syndrome (MAS) as part of previous treatment with IL-1 blockade
             (e.g. anakinra, rilonacept)

         15. Vaccination with a live vaccine within 3 months before the baseline

         16. Alcohol or drug abuse in the past 12 months

         17. ≥400 milliliter (mL) donation of blood or loss up to 8 weeks before the baseline

         18. Pregnancy or breast-feeding

         19. Commitment of the patient to an institution at the direction of an authority or court