Trial · NCT01230827
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
NCT01230827, Phase 3, Terminated, Janssen Research & Development, LLC; results first posted 2014-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS). Trials, record NCT01230827. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01230827
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
- NCT number
- NCT01230827
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 173 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- CNTO 148 (Golimumab), Placebo, Methotrexate
- First posted
- 2010-10-29
- Last updated
- 2016-04-04
- Other registries' IDs
- eudract:2009-015019-42
- Results first posted
- 2014-09-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 | Week 16 through Week 48 | Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate. |
| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48 | Week 16 through Week 48 | Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate. |
| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48 | Week 16 through Week 48 | Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes. |
| Secondary | Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48 | Week 16 through Week 48 | Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 | Week 16 through Week 48 | Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48 | Week 16 through Week 48 | Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48 | Week 16 through Week 48 | ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48 | Week 16 through Week 48 | ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 | Placebo | 52.6 | Percentage of Participants | ||
| Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 | CNTO 148 (Golimumab) | 59.0 | Percentage of Participants | ||
| Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48 | Placebo | 55.3 | Percentage of Participants | ||
| Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48 | CNTO 148 (Golimumab) | 52.6 | Percentage of Participants | ||
| Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48 | Placebo | 27.6 | Percentage of Participants | ||
| Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48 | CNTO 148 (Golimumab) | 39.7 | Percentage of Participants | ||
| Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48 | Placebo | 11.8 | Percentage of Participants | ||
| Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48 | CNTO 148 (Golimumab) | 12.8 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group I: Participants Who Did Not Enter RW Period | 19 | |
| Overall Study | STARTED | Group II: Placebo Subcutaneously (SC) + MTX | 11 | |
| Overall Study | STARTED | Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX | 65 | |
| Overall Study | STARTED | Group IV: Golimumab + MTX | 78 | |
| Overall Study | COMPLETED | Group I: Participants Who Did Not Enter RW Period | 0 | |
| Overall Study | COMPLETED | Group II: Placebo Subcutaneously (SC) + MTX | 0 | |
| Overall Study | COMPLETED | Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX | 0 | |
| Overall Study | COMPLETED | Group IV: Golimumab + MTX | 0 | |
| Overall Study | NOT COMPLETED | Group I: Participants Who Did Not Enter RW Period | 19 | |
| Overall Study | NOT COMPLETED | Group II: Placebo Subcutaneously (SC) + MTX | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events496
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pharyngitis | Infections and infestations | Group I: Participants Who Did Not Enter RW Period | 0 | 19 | |
| other | Pharyngitis | Infections and infestations | Group II: Placebo Subcutaneously (SC) + MTX | 0 | 10 | |
| other | Pharyngitis | Infections and infestations | Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX | 6 | 66 | |
| other | Pharyngitis | Infections and infestations | Group IV: Golimumab + MTX | 9 | 78 | |
| other | Pharyngitis streptococcal | Infections and infestations | Group I: Participants Who Did Not Enter RW Period | 1 | 19 | |
| other | Pharyngitis streptococcal | Infections and infestations | Group II: Placebo Subcutaneously (SC) + MTX | 0 | 10 | |
| other | Pharyngitis streptococcal | Infections and infestations | Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX | 0 | 66 | |
| other | Pharyngitis streptococcal | Infections and infestations | Group IV: Golimumab + MTX | 2 | 78 | |
| other | Respiratory tract infection | Infections and infestations | Group I: Participants Who Did Not Enter RW Period | 1 | 19 | |
| other | Respiratory tract infection | Infections and infestations | Group II: Placebo Subcutaneously (SC) + MTX | 0 | 10 |
1 to 10 of 496Source ClinicalTrials.gov
See all 496 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group I: Participants Who Did Not Enter RW Period | ||
| Total, all-cause mortality | Group II: Placebo Subcutaneously (SC) + MTX | ||
| Total, all-cause mortality | Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX | ||
| Total, all-cause mortality | Group IV: Golimumab + MTX | ||
| Total, other adverse events | Group I: Participants Who Did Not Enter RW Period | 14 | 19 |
| Total, other adverse events | Group II: Placebo Subcutaneously (SC) + MTX | 9 | 10 |
| Total, other adverse events | Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX | 60 | 66 |
| Total, other adverse events | Group IV: Golimumab + MTX | 68 | 78 |
| Total, serious adverse events | Group I: Participants Who Did Not Enter RW Period | 4 | 19 |
| Total, serious adverse events | Group II: Placebo Subcutaneously (SC) + MTX | 2 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28507219 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01230827
GET https://conductscience.org/api/trials/v1/NCT01230827/events?page=2