Participant flow

Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome · Source last updated 2017-08-28

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

groups

1. description

   ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.

   id

   FG000

   title

   ACZ885

2. description

   Placebo subcutaneous injection every 8 weeks.

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      Unsatisfactory therapeutic effect

   milestones

   1. achievements

      1. comment

         All patients received treatment with ACZ885 in Part I of the study.

         group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. comment

         Only patients with a complete response completed Part I and entered Part II of the study.

         group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Part I - Open-label Treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         12

      type

      Unsatisfactory therapeutic effect

   milestones

   1. achievements

      1. comment

         Patients with complete response to treatment entered Part II and were randomized to ACZ885 ,placebo.

         group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         16

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         4

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         12

      type

      NOT COMPLETED

   title

   Part II - 1:1 ACZ885:Placebo

3. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Unsatisfactory therapeutic effect

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   milestones

   1. achievements

      1. comment

         All patients received treatment with ACZ885 in Part III of the study.

         group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Part III - Open-label Treatment Period

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Preserved source evidence · Not medical advice