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Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients · Source last updated 2014-01-29

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

groups

1. description

   Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.

   id

   FG000

   title

   Canakinumab, Pre-filled Syringes (PFS)

2. description

   The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.

   id

   FG001

   title

   Canakinumab, Lyophilizate (LYO)

3. description

   The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.

   id

   FG002

   title

   Triamcinolone Acetonide

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Protocol Deviation

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         5

      type

      Administrative Problems

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         6

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         7

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         4

      type

      Lack of Efficacy

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Adverse Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         133

      2. group Id

         FG001

         num Subjects

         132

      3. group Id

         FG002

         num Subjects

         132

      type

      STARTED

   2. achievements

      1. comment

         In this arm, 1 patient had only 3 placebo injections and 3 patients also took other active drug.

         group Id

         FG000

         num Subjects

         133

      2. comment

         In this arm, 3 patients also took other active drug.

         group Id

         FG001

         num Subjects

         133

      3. comment

         In this arm, 3 patients also took other active drug.

         group Id

         FG002

         num Subjects

         133

      type

      Safety Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         131

      2. group Id

         FG001

         num Subjects

         129

      3. group Id

         FG002

         num Subjects

         129

      type

      Full Analysis Set

   4. achievements

      1. group Id

         FG000

         num Subjects

         124

      2. group Id

         FG001

         num Subjects

         117

      3. group Id

         FG002

         num Subjects

         108

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         24

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Number of subjects randomized was 397. Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to a safety set of 399 subjects. Subjects who did not receive study drug were excluded from analysis.

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Preserved source evidence · Not medical advice