Arthritis, JuvenilePhase 3GO-VIVANCT02277444
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 study testing Golimumab and Methotrexate in people with Arthritis, Juvenile, run by Janssen Research & Development, LLC at 38 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Arthritis, Juvenile
- What is being tested?
- Golimumab and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 38 sitesin 9 countries
- Study dates
- 22 Dec 2014to 27 Sep 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
38 sites in 9 countries.
38 sites in 9 countries
United States14 sites
Study site
Austin, Texas
Study site
Avon, Ohio
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Durham, North Carolina
Study site
Hackensack, New Jersey
Study site
Hickory, North Carolina
Study site
New Hyde Park, New York
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Salt Lake City, Utah
Study site
San Diego, California
Brazil5 sites
Study site
Botucatu
Study site
Campinas
Study site
Porto Alegre
Study site
Rio de Janeiro
Study site
São Paulo
Russia5 sites
Study site
Mosco2
Study site
Saint Petersburg
Study site
Saratov
Study site
Tolyatti
Study site
Ufa
Argentina3 sites
Study site
Buenos Aires
Study site
Rosario
Study site
San Miguel de Tucumán
Canada3 sites
Study site
Calgary, Alberta
Study site
Montreal, Quebec
Study site
Toronto, Ontario
Mexico3 sites
Study site
Chihuahua City
Study site
Guadalajara
Study site
Mexico City
About this study
Official title: A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
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
- Arthritis, Juvenile
- Being tested
- Golimumab, Methotrexate
- Keywords
- Methotrexate, Anti-TNFα Antibody, Golimumab, Pediatric Participants
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolimumabDrug
Also called Simponi Aria
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.
MethotrexateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Golimumab + Methotrexate | Experimental | 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. Receives: Drug: Golimumab; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Trough Concentration (C-trough) of Golimumab
Serum golimumab trough concentration at Week 28 was reported.
Measured: 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).
Measured: Week 28
Secondary outcomes (2)
Serum Trough Concentration (C-trough) at Week 52
Serum golimumab trough concentration at Week 52 was reported.
Measured: 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).
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study start22 Dec 2014
- Primary completion9 Jul 2018
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis, JuvenileStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277444
- Sponsor's protocol ID
- CR105178
- Other IDs
- CNTO148JIA3003, 2015-004804-47, 2015
- Acronym
- GO-VIVA
- Status last verified
- Oct 2025
- First submitted
- 27 Oct 2014
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
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 36171515Ruperto 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 at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
- ClinicalTrials.gov ID
- NCT02277444
- Acronym / sponsor ID
- GO-VIVA / CR105178
- Conditions
- Arthritis, Juvenile
- Keywords
- Methotrexate, Anti-TNFα Antibody, Golimumab, Pediatric Participants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2014 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Posted 18 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golimumab + Methotrexate | Experimental | Drug: Golimumab, Drug: MethotrexateParticipants 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GolimumabAlso: Simponi AriaGolimumab 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. | Drug | Golimumab + Methotrexate |
| MethotrexateMethotrexate 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. | Drug | Golimumab + Methotrexate |
Primary outcome
Serum Trough Concentration (C-trough) of Golimumab
Time frame: Week 28
Serum golimumab trough concentration at Week 28 was reported.
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28
Time frame: 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).
2 secondary outcomes
Serum Trough Concentration (C-trough) at Week 52
Time frame: Week 52
Baysesian Area Under Curve at Steady State (AUCss) at Week 52
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36171515Leu 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.
- Derived from this study: PubMed 33493312Ruperto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
38 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Golimumab and Methotrexate in people with Arthritis, Juvenile, run by Janssen Research & Development, LLC at 38 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Brazil, Russia, Argentina, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Trough Concentration (C-trough) of Golimumab (time frame: Week 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02277444, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.