TriangleNCT02277444 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-11-14
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Serum Trough Concentration (C-trough) of Golimumab
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28
Serum Trough Concentration (C-trough) at Week 52
Baysesian Area Under Curve at Steady State (AUCss) at Week 52
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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: * 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
- healthy Volunteers
- false
- maximum Age
- 17 Years
- minimum Age
- 2 Years
- sex
- ALL
- std Ages
- CHILD
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: Golimumab
- Drug: Methotrexate
- label
- Golimumab + Methotrexate
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Golimumab + Methotrexate
- description
- 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.
- name
- Golimumab
- other Names
- Simponi Aria
- type
- DRUG
- arm Group Labels
- Golimumab + Methotrexate
- description
- 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.
- name
- Methotrexate
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 130
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Serum golimumab trough concentration at Week 28 was reported.
- measure
- Serum Trough Concentration (C-trough) of Golimumab
- time Frame
- Week 28
- description
- 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).
- measure
- Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28
- time Frame
- Week 28
- secondary Outcomes
- description
- Serum golimumab trough concentration at Week 52 was reported.
- measure
- Serum Trough Concentration (C-trough) at Week 52
- time Frame
- Week 52
- description
- 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).
- measure
- Baysesian Area Under Curve at Steady State (AUCss) at Week 52
- time Frame
- Week 52
Full study description
- brief 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.
- 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.
Source references
- references
- citation
- 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.
- pmid
- 36171515
- type
- DERIVED
- citation
- 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.
- pmid
- 33493312
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- bel, single-arm study in 127 children (2 to < 18 years of age) with JIA with active polyarthritis despite treatment with MTX for at least 2 months (Trial pJIA, NCT02277444). The polyarticular JIA patient subtypes at study entry included: rheumatoid factor negative (43%), rheumatoid factor positive (35%), enthesitis-related arthri
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Preserved source evidence · Not medical advice