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Monoclonal Antibodies

Intravenous Golimumab for Juvenile Arthritis (GO-VIVA Trial)

Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Participants must have >=5 joints with active arthritis at screening and at Week 0 as defined by American College of Rheumatology (ACR) criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

GO-VIVA Trial Summary

This trial will study how golimumab enters and leaves the blood and tissues over time in children with arthritis that has not responded to methotrexate.

Who is the study for?
This trial is for children with polyarticular juvenile idiopathic arthritis (pJIA) affecting 5 or more joints, who haven't improved after at least 2 months on methotrexate. They must meet specific criteria including having a certain level of inflammation and being diagnosed before age 16. Kids can't join if they've recently used steroids, B or T cell depleting drugs, other DMARDs/immunosuppressives, or have had severe reactions to anti-TNF alpha agents.Check my eligibility
What is being tested?
The study tests how golimumab given through an IV affects kids with pJIA who still have joint pain despite taking methotrexate. It looks at how the drug moves in and out of the blood over time (pharmacokinetics), its safety, and effectiveness in reducing arthritis symptoms.See study design
What are the potential side effects?
Golimumab may cause side effects like infections due to immune system suppression, allergic reactions during infusion into the vein, headache, nausea, and possibly increased liver enzymes which could indicate liver issues.

GO-VIVA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with JIA before I turned 16.
Select...
I have active arthritis in 5 or more joints.
Select...
I have active juvenile arthritis and have been on MTX for 2+ months without improvement.

GO-VIVA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28
Serum Trough Concentration (C-trough) of Golimumab
Secondary outcome measures
Baysesian Area Under Curve at Steady State (AUCss) at Week 52
Serum Trough Concentration (C-trough) at Week 52

Side effects data

From 2016 Phase 4 trial • 205 Patients • NCT02092285
14%
COLITIS ULCERATIVE
10%
NASOPHARYNGITIS
7%
HEADACHE
7%
NAUSEA
7%
OROPHARYNGEAL PAIN
7%
COLITIS
1%
ACCIDENTAL OVERDOSE
1%
PULMONARY EMBOLISM
100%
80%
60%
40%
20%
0%
Study treatment Arm
Golimumab

GO-VIVA Trial Design

1Treatment groups
Experimental Treatment
Group I: Golimumab + MethotrexateExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Golimumab
2014
Completed Phase 4
~3480
Methotrexate
2013
Completed Phase 4
~3800

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,592 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,778 Total Patients Enrolled

Media Library

Juvenile Arthritis Clinical Trial 2023: Golimumab Highlights & Side Effects. Trial Name: NCT02277444 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the first time that Golimumab has been studied in a clinical trial?

"There are currently 243 trials investigating golimumab. Of these, 72 are in phase 3. New york, New York is home to many of these studies, but there are 8089 total locations running trials for this medication."

Answered by AI

Which patients does Golimumab help the most?

"While small cell lung cancer is the primary indication for golimumab, this medication can also help patients with other conditions like active pauciarticular juvenile rheumatoid arthritis, head and neck carcinoma, and multiple sclerosis."

Answered by AI

Are researchers still looking for people to participate in this trial?

"According to the latest update on clinicaltrials.gov, this trial is not recruiting patients at the moment. The trial was first posted on December 17th, 2014 and was last updated on November 3rd, 2020. Despite this, there are 625 other trials that are actively recruiting patients."

Answered by AI

When did the FDA give its okay to Golimumab?

"Golimumab has received a safety score of 3 from our team at Power. This is because Phase 3 trials have shown some efficacy and multiple rounds of data support safety."

Answered by AI

Does this experiment have any age restrictions?

"Participants in this trial must have turned 2 years old but cannot be older than 17 years old."

Answered by AI

Would I be a good candidate to participate in this research project?

"This clinical study is investigating a new treatment for arthritis in children aged 2-17. To participate, 130 young patients must meet the criteria of having juvenile arthritis."

Answered by AI

How many different staff members are managing this clinical trial in different locations?

"Currently, this study is enrolling patients from 16 different locations, which are situated in Philadelphia, Hackensack, Cleveland and other cities. To reduce the demand for travel, it is best to select the clinical trial site that is nearest to you."

Answered by AI

For how many people is this research opportunity open?

"This study is no longer recruiting patients. The clinical trial was first posted on December 17th, 2014 and was most recently edited on November 3rd, 2022. However, there are presently 382 studies actively recruiting participants with arthritis and 243 trials for Golimumab that are admitting patients."

Answered by AI
Recent research and studies
~13 spots leftby Mar 2025