CompletedNCT02277444GO-VIVAUpdated Nov 14, 2025Results posted

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

A Phase 3 interventional study of Golimumab and Methotrexate in Arthritis, Juvenile, sponsored by Janssen Research & Development, LLC. Completed at 38 sites in 9 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-11-14.

Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 130
Allocation: Not applicable
Ages: 2 Years to 17 Years
Sex: All

Study summary

The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested by greater than or equal to (>=) 5 joints with active arthritis despite methotrexate (MTX) therapy for >= 2 months.

Read the detailed description

This is a single arm, Open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study) study to determine the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), efficacy (effectiveness) and safety of intravenous golimumab in participants with pJIA despite current treatment with methotrexate (MTX). The study will consist of 3 parts: Screening Phase (6 weeks); an Open-label Treatment Phase (consists of golimumab and MTX treatment for 52 weeks, wherein after Week 28, MTX dose change is allowed); Long-term Extension Phase (after Week 52 through Week 252) and Extended Treatment Period (after week 252). The maximal study duration for a participant will not exceed 832 weeks. All the eligible participants will be administered golimumab IV infusion and commercial MTX. Blood samples will be collected for evaluation of pharmacokinetics of study treatment. Participants' safety will be monitored throughout the study.

Conditions studied

Arthritis, Juvenile

Browse trials for

Arthritis, Juvenile 352

Keywords

Methotrexate
Anti-TNFα Antibody
Golimumab
Pediatric Participants

In context

Arthritis, Juvenile

352 studies on the registry are indexed under Arthritis, Juvenile; 92 are open to participants now.

This study's enrollment of 130 is above the median of 50 across 225 interventional studies indexed under Arthritis, Juvenile.

Browse Arthritis, Juvenile studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis must be made per Juvenile Idiopathic Arthritis (JIA) International League of Associations for Rheumatology (ILAR) diagnostic criteria and the onset of disease must have been before the participant's 16th birthday
Failure or inadequate response to at least a 2 month course of methotrexate (MTX) before screening
Participants must have greater than or equal to (>=) 5 joints with active arthritis at screening and at Week 0 as defined by American College of Rheumatology (ACR) criteria (that is, a joint with either swelling, or in the absence of swelling, limited range of motion associated with pain on motion or tenderness)
Participants must have a screening C-reactive protein (CRP) of >=0.1 milligram (mg)/deciliter (dL) with the exception of approximately 30 percent (%) of the study population
Participants must have active polyarticular juvenile idiopathic arthritis (pJIA) despite current use of oral, intramuscular, or subcutaneous MTX for >=2 months before screening. For participants with body surface area (BSA) less than (\<)1.67 meter square (m\^2), the MTX dose must be between 10 to 30 milligram per meter square (mg/m\^2) per week and stable for >=4 weeks before screening. For participants with BSA >=1.67 m\^2, the MTX dose must be a minimum of 15 mg/week and must be stable for >=4 weeks before screening. In situations where there is documented intolerance of doses greater than (>)10 mg/m\^2 weekly (for participants with BSA \<1.67 m\^2) or >=15 mg/week (for participants with BSA >=1.67 m\^2); or where documented country or site regulations prohibit use of >=15 mg of MTX per week in participants with BSA >=1.67 m\^2, participants may be entered into the trial on a lower dose of MTX

Exclusion criteria

Exclusion Criteria:

Participant has initiated disease-modifying antirheumatic drugs (DMARDs) and/or immunosuppressive therapy within 4 weeks prior to first study agent administration
Participant has been treated with intra-articular, intramuscular or intravenous corticosteroids (including intramuscular corticotropin) during the 4 weeks before first study agent administration
Participant has been treated with any therapeutic agent targeted at reducing Interleukin (IL)-12 or IL 23, including but not limited to ustekinumab and ABT-874, within 3 months before first study agent administration
Participant has been treated with natalizumab, efalizumab, or therapeutic agents that deplete B or T cells (eg, rituximab, alemtuzumab, or visilizumab) during the 12 months before first study agent administration, or have evidence at screening of persistent depletion of the targeted lymphocyte after receiving any of these agents
Participant has been treated with alefacept within 3 months before first study agent administration
If a participant has been previously treated with an anti-tumor necrosis factor alpha (TNF alpha) agent, the reason for discontinuation of the anti-TNF alpha agent cannot have been a severe or serious adverse event consistent with the class of anti-TNF alpha agents

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 130 participants (actual)

Study arms

Experimental
Golimumab + Methotrexate
Participants will receive 80 milligram per meter square (mg/m\^2) as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks thereafter up to Week 244, along with 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 the time of study entry. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m\^2 every 8 weeks after completion of the Week 252 assessments.
Drug: Golimumab · Drug: Methotrexate

Interventions

DrugGolimumab
Golimumab 80 mg/m\^2 IV infusion at Weeks 0, 4, and every 8 weeks through Week 244. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m\^2 every 8 weeks after completion of the Week 252 assessments.
Also known as: Simponi Aria
DrugMethotrexate
Methotrexate BSA-based dose (10 to 30 mg/m\^2 per week for participants with BSA \<1.67 m\^2, or minimum of 15 mg/week for participants with BSA \>=1.67 m\^2) weekly at least through Week 28.

What researchers measure

Primary outcomes

Serum Trough Concentration (C-trough) of Golimumab
Serum golimumab trough concentration at Week 28 was reported.
Time frame: Week 28
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at 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).
Time frame: Week 28

Secondary outcomes

Serum Trough Concentration (C-trough) at Week 52
Serum golimumab trough concentration at Week 52 was reported.
Time frame: Week 52
Baysesian Area Under Curve at Steady State (AUCss) at 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).
Time frame: Week 52

Results

Posted Nov 18, 2020

Participant flow

Treatment Period (Week 0-52)

Participant flow — Treatment Period (Week 0-52)
Milestone	Golimumab
Started	130
Treated	127
Completed	112
Not completed	18
Withdrew: Adverse event	11
Withdrew: Withdrawal by subject	3
Withdrew: Other	1
Withdrew: Enrolled and not treated	3

LTE Period (Week 52 to Week 252)

Participant flow — LTE Period (Week 52 to Week 252)
Milestone	Golimumab
Started	112
Completed	69
Not completed	43
Withdrew: Other	43

ETP Period (Week 252 to Week 420)

Participant flow — ETP Period (Week 252 to Week 420)
Milestone	Golimumab
Started	32
Completed	18
Not completed	14
Withdrew: Adverse event	1
Withdrew: Physician decision	3
Withdrew: Withdrawal by subject	2
Withdrew: Other	8

Outcome measures

PrimarySerum Trough Concentration (C-trough) of Golimumab

Serum golimumab trough concentration at Week 28 was reported.

Time frame:: Week 28
Reported as:: Mean · micrograms per milliliter (mcg/mL)

Serum Trough Concentration (C-trough) of Golimumab
micrograms per milliliter (mcg/mL)	Golimumab
Serum Trough Concentration (C-trough) of Golimumab	0.50 ± 0.427

PrimaryBayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at 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).

Time frame:: Week 28
Reported as:: Median · micrograms*day/milliliter (mcg*day/mL)

Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28
microgramsday/milliliter (mcgday/mL)	Golimumab
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28	399 (387 to 424)

SecondarySerum Trough Concentration (C-trough) at Week 52

Serum golimumab trough concentration at Week 52 was reported.

Time frame:: Week 52
Reported as:: Mean · mcg/mL

Serum Trough Concentration (C-trough) at Week 52
mcg/mL	Golimumab
Serum Trough Concentration (C-trough) at Week 52	0.52 ± 0.475

SecondaryBaysesian Area Under Curve at Steady State (AUCss) at 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).

Time frame:: Week 52
Reported as:: Median · mcg*day/mL

Baysesian Area Under Curve at Steady State (AUCss) at Week 52
mcg*day/mL	Golimumab
Baysesian Area Under Curve at Steady State (AUCss) at Week 52	421 (402 to 446)

Adverse events

Collected over Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	1/127 (0.8%)	9/127 (7.1%)	74/127 (58.3%)
LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	1/127 (0.8%)	18/127 (14.2%)	57/127 (44.9%)
ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w	0/32 (0%)	3/32 (9.4%)	8/32 (25%)

Most frequent serious events

Showing 10 of 34

Most frequent serious events
Event	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w
CalcinosisGeneral disorders	0/127	1/127	1/32
Ocular Implant ExposureGeneral disorders	0/127	0/127	1/32
AppendicitisInfections and infestations	0/127	0/127	1/32
MyopericarditisCardiac disorders	0/127	1/127	0/32
Supraventricular TachycardiaCardiac disorders	0/127	1/127	0/32
GlaucomaEye disorders	0/127	1/127	0/32
Retinal DetachmentEye disorders	0/127	1/127	0/32
ConstipationGastrointestinal disorders	0/127	1/127	0/32
Crohn's DiseaseGastrointestinal disorders	0/127	1/127	0/32
GastritisGastrointestinal disorders	0/127	1/127	0/32

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w	LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w	ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w
Upper Respiratory Tract InfectionInfections and infestations	28/127	19/127	1/32
NasopharyngitisInfections and infestations	22/127	16/127	2/32
Juvenile Idiopathic ArthritisMusculoskeletal and connective tissue disorders	14/127	18/127	2/32
HeadacheNervous system disorders	14/127	6/127	1/32
GastroenteritisInfections and infestations	6/127	12/127	1/32
Urinary Tract InfectionInfections and infestations	1/127	12/127	0/32
ArthritisNervous system disorders	4/127	7/127	3/32
NauseaGastrointestinal disorders	11/127	7/127	0/32
VomitingGastrointestinal disorders	10/127	5/127	0/32
Abdominal PainGastrointestinal disorders	8/127	2/127	0/32

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)	Golimumab
Mean	11.6 ± 3.85

Sex: Female, Male
Sex: Female, Male(Participants)	Golimumab
Female	93
Male	34

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Golimumab
Hispanic or Latino	63
Not Hispanic or Latino	62
Unknown or Not Reported	2

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Golimumab
American Indian or Alaska Native	4
Asian	1
Black or African American	5
More than one race	4
Other	28
White	85

Region of Enrollment
Region of Enrollment(Participants)	Golimumab
ARGENTINA	18
BRAZIL	16
CANADA	7
CHILE	7
ISRAEL	2
MEXICO	25
RUSSIAN FEDERATION	14
SOUTH AFRICA	15
UNITED STATES	23

Study locations

38 sites

San Diego, California, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Hackensack, New Jersey, United States
New Hyde Park, New York, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
Avon, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Austin, Texas, United States
Salt Lake City, Utah, United States
Buenos Aires, Argentina
Rosario, Argentina
San Miguel de Tucumán, Argentina
Botucatu, Brazil
Campinas, Brazil
Porto Alegre, Brazil
Rio de Janeiro, Brazil
São Paulo, Brazil
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Región Metropolitana de Santia, Chile
Haifa, Israel
Kfar Saba, Israel
Petah Tikva, Israel
Chihuahua City, Mexico
Guadalajara, Mexico
Mexico City, Mexico
Mosco2, Russia
Saint Petersburg, Russia
Saratov, Russia
Tolyatti, Russia
Ufa, Russia
Cape Town, South Africa

References and documents

Publications

Leu JH, Shiff NJ, Clark M, Bensley K, Lomax KG, Berezny K, Nelson RM, Zhou H, Xu Z. Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs. 2022 Nov;24(6):699-714. doi: 10.1007/s40272-022-00533-y. Epub 2022 Sep 28. PubMed 36171515 ↗
Ruperto N, Brunner HI, Pacheco-Tena C, Louw I, Vega-Cornejo G, Spindler AJ, Kingsbury DJ, Schmeling H, Borzutzky A, Cuttica R, Inman CJ, Malievskiy V, Scott C, Keltsev V, Terreri MT, Viola DO, Xavier RM, Fernandes TAP, Velazquez MDRM, Henrickson M, Clark MB, Bensley KA, Li X, Lo KH, Leu JH, Hsu CH, Hsia EC, Xu Z, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4495-4507. doi: 10.1093/rheumatology/keab021. PubMed 33493312 ↗

Study documents

Study protocol · Apr 17, 2020
Statistical analysis plan · Aug 1, 2018

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02277444
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Oct 29, 2014
Start date: Dec 22, 2014
Primary completion: Jul 9, 2018
Completion: Sep 27, 2024
Results posted: Nov 18, 2020
Last update: Nov 14, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial

study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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