Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00029042
Status:
TERMINATED
Last Update Posted:
2008-08-27
First Post:
2002-01-04
Brief Title:
Infliximab to Treat Children With Juvenile Rheumatoid Arthritis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Double Blind Controlled Intra-Patient Dose Escalation Phase II Trial of Infliximab in Pediatric Patients With Refractory Juvenile Rheumatoid Arthritis
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether a stepwise increase of the drug infliximab Remicade Registered Trademark controls juvenile rheumatoid arthritis more effectively than a fixed dose It will look at the safety and effectiveness of increasing the dose to a maximum of 15mgkg body weight per dose examining the drugs effect on bone and cartilage and whether it can improve abnormal growth metabolism and hormones Infliximab is approved for treating adults with rheumatoid arthritis and Crohns disease
Children between 4 and 17 years of age with active juvenile rheumatoid arthritis who do not respond adequately to standard therapy may be eligible for this study
Participants will receive nine infusions of infliximab during this 62-week study The drug is given intravenously IV into a vein over 2 hours The first three infusions will be at a dose of 5 mgkg of body weight Children who improve on this regimen will receive another 6 infusions at the same dose Children who do not significantly improve on 5 mgkg at the end of 6 weeks the third infusion may continue with phase 2 of the study in which they will be randomly assigned to receive either 1 6 additional doses of the drug at 5 mgkg per dose or 2 a gradually increased dose to a maximum of 15 mgkg In addition all children will continue to take methotrexate at the same dose as when they entered the study
Participants will visit the NIH Clinical Center 12 times about every 8 weeks during the study for the following tests and procedures
History and physical examination including a complete joint exam
Puberty assessment - breast development in girls testicle size in boys and pubic hair
Height and weight measurements
Children will have imaging studies x-rays MRI and Dexa scan at the beginning and end of the study and will collect a 24-hour urine sample before each infliximab infusion
Patients may elect to have an endocrine evaluation This involves Clinical Center hospitalizations for 1-12 days on visits 1 4 and 12 Small amounts of blood will be drawn every 20 minutes through an indwelling catheter to avoid multiple needle sticks for 8 hours while the child sleeps The blood will be examined for the normal rhythm of growth hormone and other substances in the body and how they are affected by arthritis
Participants will complete a questionnaire once a year for 2 years to provide information on their health status and any problems that might be related to the study drug
Children between 4 and 17 years of age with active juvenile rheumatoid arthritis who do not respond adequately to standard therapy may be eligible for this study
Participants will receive nine infusions of infliximab during this 62-week study The drug is given intravenously IV into a vein over 2 hours The first three infusions will be at a dose of 5 mgkg of body weight Children who improve on this regimen will receive another 6 infusions at the same dose Children who do not significantly improve on 5 mgkg at the end of 6 weeks the third infusion may continue with phase 2 of the study in which they will be randomly assigned to receive either 1 6 additional doses of the drug at 5 mgkg per dose or 2 a gradually increased dose to a maximum of 15 mgkg In addition all children will continue to take methotrexate at the same dose as when they entered the study
Participants will visit the NIH Clinical Center 12 times about every 8 weeks during the study for the following tests and procedures
History and physical examination including a complete joint exam
Puberty assessment - breast development in girls testicle size in boys and pubic hair
Height and weight measurements
Children will have imaging studies x-rays MRI and Dexa scan at the beginning and end of the study and will collect a 24-hour urine sample before each infliximab infusion
Patients may elect to have an endocrine evaluation This involves Clinical Center hospitalizations for 1-12 days on visits 1 4 and 12 Small amounts of blood will be drawn every 20 minutes through an indwelling catheter to avoid multiple needle sticks for 8 hours while the child sleeps The blood will be examined for the normal rhythm of growth hormone and other substances in the body and how they are affected by arthritis
Participants will complete a questionnaire once a year for 2 years to provide information on their health status and any problems that might be related to the study drug
Detailed Description:
Infliximab a murine chimeric monoclonal antibody targeted against TNF-alpha has recently been licensed for the treatment of adult patients with established rheumatoid arthritis RA A double blind placebo controlled trial in children with juvenile rheumatoid arthritis JRA using a single dose fixed infusion regimen is currently ongoing This dose finding study is designed to determine whether a clinically guided intravenous iv infusion regimen allowing for intra-patient dose escalation is superior in achieving a 70 clinical response to fixed dose administration of infliximab in children with a polyarticular course of JRA We will model the pharmacokinetic profile in both phases of the study We plan to enroll a maximum of 48 patients to allow for 36 patients to be randomized into the two treatment arms In the first phase of the study all patients will receive a fixed dose of 5mgkgdose for a total of 3 infusions over 6 weeks weeks 0 2 6 In the second phase at week 14 patients who have not achieved a 70 improvement will be randomized at a 21 ratio to either receive intra-patient dose escalation capped at 15mgkgdose every 8 weeks or continue to receive 5mgkgdose every 8 weeks in a blinded fashion After 6 additional IV doses patients will again be evaluated clinically radiographically and serologically for clinical response Patients who achieved a 70 response by week 14 will be kept on 5mgkgdose every 8 weeks for the trial duration of 62 weeks but will not be included in the primary endpoint analysis We also plan to evaluate patients endocrinologically and metabolically to determine the effect of TNF blockade on these systems
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-AR-0081 | None | None | None |