Participant flow

Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) · Source last updated 2012-10-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.

   id

   FG000

   title

   Canakinumab

2. description

   Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         72

      2. group Id

         FG001

         num Subjects

         0

      type

      Unsatisfactory therapeutic effect

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         177

      2. comment

         No participants received placebo in Part I.

         group Id

         FG001

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         145

      2. group Id

         FG001

         num Subjects

         0

      type

      Entered Part Ia

   3. achievements

      1. group Id

         FG000

         num Subjects

         142

      2. group Id

         FG001

         num Subjects

         0

      type

      Entered Part Ib

   4. achievements

      1. comment

         Patients steroid free at study entry entered Part Id directly and did not participate in Part Ic.

         group Id

         FG000

         num Subjects

         92

      2. group Id

         FG001

         num Subjects

         0

      type

      Entered Part Ic

   5. achievements

      1. group Id

         FG000

         num Subjects

         103

      2. group Id

         FG001

         num Subjects

         0

      type

      Entered Part 1d

   6. achievements

      1. group Id

         FG000

         num Subjects

         100

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         77

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Part I: Open Label

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         20

      type

      Unsatisfactory therapeutic effect

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol deviation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         50

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         39

      2. group Id

         FG001

         num Subjects

         24

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         26

      type

      NOT COMPLETED

   title

   Part II: Randomized Double Blind

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Preserved source evidence · Not medical advice