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GO VIVA

Trial

Clinical Trial Title

A Multicenter, Open-Label Trial of Intravenous Golimumab, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis (GO VIVA)

Trial Status

Closed to Enrollment

Start Date

January 1, 2015

Trial Type

Pediatric Rheumatology

Specific Condition

Juvenile Idiopathic Arthritis

Description

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).

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 244 weeks, wherein after week 28, MTX dose change is allowed) and follow-up Phase (8 weeks). The maximal study duration for a participant will not exceed 252 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.

 

Eligibility Criteria

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 3 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
  • Participants must have a Screening C-reactive protein (CRP) of >=0.1 milligram (mg)/Deciliter (dL)
  • Participants must have active JIA despite current use of oral, intramuscular or subcutaneous MTX (for >=3 months before Screening and on a stable dose for 4 weeks) at a weekly dose of >=10 mg/Meter (m)^2. Participants currently on MTX (weekly 10 to 30 mg/m^2), must receive a stable dose of MTX for >=4 weeks before Screening. Participants with body surface area (BSA) >=1.67 m^2 must receive a minimum of 15 mg/week of MTX unless documented country or site regulations prohibit use of 15 mg of MTX per week in Participants with BSA >=1.67 m^2. In situations where there is documented intolerance of doses greater than (>) 10 mg/m^2 weekly or 15 mg/week for 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
  • 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

IRB Number

10646

Notes

https://clinicaltrials.gov/ct2/show/NCT02277444

Study status is:
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Principal Investigator Name

Daniel Kingsbury, MD

Contact Name

Kristin Hickey

Phone

503-413-5447

Contact Fax

503-413-3543

Contact E-Mail

khickey@lhs.org

Last Updated: Wednesday, January 27, 2021 12:07:37 PM