Baseline characteristics

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.

denoms

1. counts

   1. group Id

      BG000

      value

      249

   2. group Id

      BG001

      value

      249

   3. group Id

      BG002

      value

      250

   4. group Id

      BG003

      value

      748

   units

   Participants

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

   BG000

   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

   BG001

   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

   BG002

   title

   Rituximab (1.0 g x 2) + Methotrexate

4. description

   Total of all reporting groups

   id

   BG003

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            12.692

            value

            48.06

         2. group Id

            BG001

            spread

            13.391

            value

            47.87

         3. group Id

            BG002

            spread

            13.324

            value

            47.89

         4. group Id

            BG003

            spread

            13.136

            value

            47.94

   description

   Intent-to-treat population

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            192

         2. group Id

            BG001

            value

            203

         3. group Id

            BG002

            value

            212

         4. group Id

            BG003

            value

            607

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            57

         2. group Id

            BG001

            value

            46

         3. group Id

            BG002

            value

            38

         4. group Id

            BG003

            value

            141

         title

         Male

   description

   Intent-to-treat population

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

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

Preserved source evidence · Not medical advice