Baseline characteristics

A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy · Source last updated 2025-11-14

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

      127

   units

   Participants

groups

1. description

   Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.

   id

   BG000

   title

   Golimumab

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            spread

            3.85

            value

            11.6

   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

            93

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            34

         title

         Male

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex: Female, Male

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            63

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            62

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            2

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Ethnicity (NIH/OMB)

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            4

      title

      American Indian or Alaska Native

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            1

      title

      Asian

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            5

      title

      Black or African American

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            4

      title

      More than one race

   5. categories

      1. measurements

         1. group Id

            BG000

            value

            28

      title

      Other

   6. categories

      1. measurements

         1. group Id

            BG000

            value

            85

      title

      White

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

5. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            18

      title

      ARGENTINA

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            16

      title

      BRAZIL

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            7

      title

      CANADA

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            7

      title

      CHILE

   5. categories

      1. measurements

         1. group Id

            BG000

            value

            2

      title

      ISRAEL

   6. categories

      1. measurements

         1. group Id

            BG000

            value

            25

      title

      MEXICO

   7. categories

      1. measurements

         1. group Id

            BG000

            value

            14

      title

      RUSSIAN FEDERATION

   8. categories

      1. measurements

         1. group Id

            BG000

            value

            15

      title

      SOUTH AFRICA

   9. categories

      1. measurements

         1. group Id

            BG000

            value

            23

      title

      UNITED STATES

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Region of Enrollment

   unit Of Measure

   Participants

population Description

Full analysis set included all participants who received at least 1 dose of study agent.

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Preserved source evidence · Not medical advice