Participant flow

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis · Source last updated 2014-02-17

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

groups

1. description

   Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).

   id

   FG000

   title

   Placebo

2. description

   Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.

   id

   FG001

   title

   Golimumab 100 mg -> 50 mg

3. description

   Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).

   id

   FG002

   title

   Golimumab 200 mg -> 100 mg

4. description

   Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).

   id

   FG003

   title

   Golimumab 400 mg -> 200 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      type

      Unsatisfactory therapeutic effect

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         2

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         331

      2. group Id

         FG001

         num Subjects

         72

      3. group Id

         FG002

         num Subjects

         331

      4. group Id

         FG003

         num Subjects

         331

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         324

      2. group Id

         FG001

         num Subjects

         69

      3. group Id

         FG002

         num Subjects

         328

      4. group Id

         FG003

         num Subjects

         327

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were assigned to Placebo, Golimumab 100 mg-\>50 mg, Golimumab 200 mg-\>100 mg and Golimumab 400 mg-\>200 mg groups for dose selection. Efficacy results were reported for only newly enrolled participants assigned to Placebo, Golimumab 200 mg-\>100 mg and Golimumab 400 mg-\>200 mg groups after dose-selection as per planned analysis.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice