Trial · NCT02277444

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

NCT02277444, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2020-11-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02277444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02277444

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT02277444
Status: Completed
Phases: Phase 3
Enrollment: 130 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Arthritis, Juvenile
Interventions: Golimumab, Methotrexate
First posted: 2014-10-29
Last updated: 2025-11-14
Other registries' IDs: eudract:2015-004804-47
Results first posted: 2020-11-18

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Serum Trough Concentration (C-trough) of Golimumab	Week 28	Serum golimumab trough concentration at Week 28 was reported.
Primary	Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28	Week 28	AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
Secondary	Serum Trough Concentration (C-trough) at Week 52	Week 52	Serum golimumab trough concentration at Week 52 was reported.
Secondary	Baysesian Area Under Curve at Steady State (AUCss) at Week 52	Week 52	AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

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	Serum Trough Concentration (C-trough) of Golimumab	Week 28	The pharmacokinetic (PK) analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.	micrograms per milliliter (mcg/mL)	MEAN
PRIMARY	Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28	Week 28	The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.	microgramsday/milliliter (mcgday/mL)	MEDIAN
SECONDARY	Serum Trough Concentration (C-trough) at Week 52	Week 52	The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.	mcg/mL	MEAN
SECONDARY	Baysesian Area Under Curve at Steady State (AUCss) at Week 52	Week 52	The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.	mcg*day/mL	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Serum Trough Concentration (C-trough) of Golimumab	Golimumab	0.50	Standard Deviation 0.427	micrograms per milliliter (mcg/mL)
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28	Golimumab	399	Full Range 387 to 424	microgramsday/milliliter (mcgday/mL)
Serum Trough Concentration (C-trough) at Week 52	Golimumab	0.52	Standard Deviation 0.475	mcg/mL
Baysesian Area Under Curve at Steady State (AUCss) at Week 52	Golimumab	421	Full Range 402 to 446	mcg*day/mL

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period (Week 0-52)	STARTED	Golimumab	130
Treatment Period (Week 0-52)	Treated	Golimumab	127
Treatment Period (Week 0-52)	COMPLETED	Golimumab	112
Treatment Period (Week 0-52)	NOT COMPLETED	Golimumab	18
LTE Period (Week 52 to Week 252)	STARTED	Golimumab	112
LTE Period (Week 52 to Week 252)	COMPLETED	Golimumab	69
LTE Period (Week 52 to Week 252)	NOT COMPLETED	Golimumab	43
ETP Period (Week 252 to Week 420)	STARTED	Golimumab	32
ETP Period (Week 252 to Week 420)	COMPLETED	Golimumab	18
ETP Period (Week 252 to Week 420)	NOT COMPLETED	Golimumab	14

Source ClinicalTrials.gov

Adverse events138

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
other	Abdominal Pain	Gastrointestinal disorders	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	8	127
other	Abdominal Pain	Gastrointestinal disorders	LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	2	127
other	Abdominal Pain	Gastrointestinal disorders	ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w	0	32
other	Nausea	Gastrointestinal disorders	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	11	127
other	Nausea	Gastrointestinal disorders	LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	7	127
other	Nausea	Gastrointestinal disorders	ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w	0	32
other	Vomiting	Gastrointestinal disorders	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	10	127
other	Vomiting	Gastrointestinal disorders	LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	5	127
other	Vomiting	Gastrointestinal disorders	ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w	0	32
other	Gastroenteritis	Infections and infestations	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	6	127

1 to 10 of 138Source ClinicalTrials.gov

See all 138 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	1	127
Total, all-cause mortality	LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	1	127
Total, all-cause mortality	ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w	0	32
Total, other adverse events	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	74	127
Total, other adverse events	LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	57	127
Total, other adverse events	ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w	8	32
Total, serious adverse events	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	9	127
Total, serious adverse events	LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	18	127
Total, serious adverse events	ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w	3	32

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33493312	DERIVED	PubMed
36171515	DERIVED	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02277444

GET https://conductscience.org/api/trials/v1/NCT02277444/events?page=2

API reference For AI assistants