Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patient… (NCT00991146) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase
Japan19 participantsStarted 2009-10
Plain-language summary
To date there are no approved effective therapies for the treatment of cryopyrin-associated periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), or Neonatal Onset Multisystem Inflammatory Disease (NOMID) in Japan.
The study will assess the efficacy and safety of canakinumab in Japanese patients with cryopyrin-associated periodic syndromes (CAPS). In previous and currently ongoing CAPS studies (CACZ885A2102, CACZ885D2201, CACZ885D2304, CACZ885D2306), it has been observed that treatment with canakinumab in patients with CAPS contributed to ensure absence of relapse, to improve signs and symptoms and to prevent secondary disease complications. However, no Japanese patients have been included in those studies. This study will allow access for Japanese patients to a new potentially efficacious treatment for CAPS patients with a convenient dosing regimen.
Who can participate
Age range2 Years
SexALL
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Inclusion criteria
✓. At study entry, patients should have a clinical diagnosis of FCAS, MWS or NOMID and require medication. At the time of screening, patients can be either untreated or treated with other medication.
✓. Presence, or history of at least 2 of the following symptoms:
✓. Patients requiring oral steroids, NSAIDs and/or disease-modifying antirheumatic drugs (DMARDs) can be enrolled if they are on a stable dose (oral steroids: \< 20 mg/day or \< or = 0.4 mg/kg prednisone or prednisone equivalent, whichever applies) for at least 4 weeks prior to the screening visit.
✓. Able to communicate with the investigator and comply with the requirements of the study (for children the parent can assist when necessary).
Exclusion criteria
✕. Pregnant or nursing (lactating) women.
✕. All women capable of becoming pregnant unless they are postmenopausal or are using one or more methods of contraception.
✕. Participation in any other study within 30 days