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NCT00029042 · ClinicalTrials.gov registry record · Phase 2
Infliximab to Treat Children With Juvenile Rheumatoid Arthritis
A Phase 2 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Terminated
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00029042 is a Phase 2 study that was terminated before completion, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 48 participants.
The verdict
NCT00029042, a Phase 2 study, was terminated before completion, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study 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 15mg/kg body weight per dose, examining the drug's 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 Crohn's 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 mg/kg 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 mg/kg 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 mg/kg per dose, or 2) a gradually increased dose to a maximum of 15 mg/kg. 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 hospitalizati
Interventions
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2002-01 |
| Est. Completion | 2005-10 |
| Phase | Phase 2 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00029042
The ClinicalTrials.gov registry entry for NCT00029042 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Infliximab is the first listed.
NCT00029042 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00029042 about?
NCT00029042 is a clinical study titled "Infliximab to Treat Children With Juvenile Rheumatoid Arthritis". 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 15mg/kg body weight per dose,...
What is the current status of trial NCT00029042?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2002-01. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00029042?
The interventions under investigation include: Infliximab (DRUG).
Who is sponsoring clinical trial NCT00029042?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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