Participant flow

A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis · Source last updated 2017-07-28

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

groups

1. description

   Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.

   id

   FG000

   title

   Placebo + Methotrexate

2. description

   Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6

   id

   FG001

   title

   Rituximab (0.5 g x 2) + Methotrexate

3. description

   Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6

   id

   FG002

   title

   Rituximab (1.0 g x 2) + Methotrexate

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         7

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         34

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         8

      type

      Insufficient therapeutic response

   4. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         8

      type

      Failure to return

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Violation of selection criteria

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Violation

   7. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      type

      Refused treatment

   8. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         19

      3. group Id

         FG002

         num Subjects

         9

      type

      Withdrew consent

   9. reasons

      1. group Id

         FG000

         num Subjects

         106

      2. group Id

         FG001

         num Subjects

         120

      3. group Id

         FG002

         num Subjects

         137

      type

      Administrative reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         251

      2. group Id

         FG001

         num Subjects

         252

      3. group Id

         FG002

         num Subjects

         252

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         249

      2. group Id

         FG001

         num Subjects

         249

      3. group Id

         FG002

         num Subjects

         250

      type

      Safety/ITT: Received Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         227

      2. group Id

         FG001

         num Subjects

         240

      3. group Id

         FG002

         num Subjects

         241

      type

      Completed Week 24

   4. achievements

      1. group Id

         FG000

         num Subjects

         213

      2. group Id

         FG001

         num Subjects

         227

      3. group Id

         FG002

         num Subjects

         232

      type

      Completed Week 52

   5. achievements

      1. group Id

         FG000

         num Subjects

         178

      2. group Id

         FG001

         num Subjects

         213

      3. group Id

         FG002

         num Subjects

         216

      type

      Completed Week 104

   6. achievements

      1. comment

         Completed Week 152

         group Id

         FG000

         num Subjects

         62

      2. group Id

         FG001

         num Subjects

         77

      3. group Id

         FG002

         num Subjects

         80

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         189

      2. group Id

         FG001

         num Subjects

         175

      3. group Id

         FG002

         num Subjects

         172

      type

      NOT COMPLETED

   title

   Treatment Period

2. 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

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         20

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         21

      3. group Id

         FG002

         num Subjects

         11

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         5

      type

      Administrative reasons

   milestones

   1. achievements

      1. comment

         All participants who received treatment were to enter SFU even if withdrawn during treatment period.

         group Id

         FG000

         num Subjects

         184

      2. comment

         All participants who received treatment were to enter SFU even if withdrawn during treatment period.

         group Id

         FG001

         num Subjects

         212

      3. comment

         All participants who received treatment were to enter SFU even if withdrawn during treatment period.

         group Id

         FG002

         num Subjects

         213

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         129

      2. group Id

         FG001

         num Subjects

         171

      3. group Id

         FG002

         num Subjects

         176

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         55

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         37

      type

      NOT COMPLETED

   title

   Safety Follow-Up (SFU) Period

3. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         8

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      type

      Administrative reasons

   milestones

   1. achievements

      1. comment

         Only participants with CD19+ B-cell counts below baseline level or less than 80 cells/microliter.

         group Id

         FG000

         num Subjects

         34

      2. comment

         Only participants with CD19+ B-cell counts below baseline level or less than 80 cells/microliter.

         group Id

         FG001

         num Subjects

         40

      3. comment

         Only participants with CD19+ B-cell counts below baseline level or less than 80 cells/microliter.

         group Id

         FG002

         num Subjects

         51

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         31

      3. group Id

         FG002

         num Subjects

         39

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         12

      type

      NOT COMPLETED

   title

   Extended Safety Follow-Up (ESFU) Period

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Preserved source evidence · Not medical advice