Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246064
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-10-28
Brief Title:
The Infliximab Rheumatoid Arthritis Methotrexate Tapering iRAMT Protocol
Sponsor:
Centocor Ortho Biotech Services LLC
Organization:
Centocor Ortho Biotech Services LLC
Study Overview
Official Title:
The Infliximab Rheumatoid Arthritis Methotrexate Tapering iRAMT Protocol Tapering Methotrexate in Patients With Rheumatoid Arthritis Beginning Therapy With Infliximab
Status:
COMPLETED
Status Verified Date:
2011-01
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:
The purpose of the study was to evaluate the ability of a maintenance dosage regimen of infliximab to achieve and sustain at least 40 improvement from baseline in the total joint count in patients with active Rheumatoid Arthritis RA during methotrexate tapering
Detailed Description:
Rheumatoid arthritis RA is a chronic autoimmune disorder of unknown etiology that occurs in approximately one percent of the population Current therapy for RA comprises non-steroidal anti-inflammatory drugs NSAIDs in early stages of the disease ultimately giving way to oral glucocorticoids and the disease-modifying anti-rheumatic drugs DMARDs as the disease progressively worsens Therapy with DMARDs eg D-penicillamine auranofin hydroxychloroquine azathioprine methotrexate is not ideal in that they generally have a slow onset of action measured in months variable levels of effectiveness and dose-limiting toxicity Methotrexate MTX has become the DMARD of choice of many rheumatologists because of its faster mode of action and better record of prolonged use However despite the use of high doses of MTX many patients only experience partial relief of symptoms and still have features of active disease The current product labeling provides for a range of infliximab doses Four fixed maintenance dose regimens proved to be safe and efficacious in the Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy ATTRACT trial However the efficacy of incremental dose titration in patients with RA who have not achieved or maintained a clinically important improvement from baseline status has not been established in a clinical trial setting Additionally whether MTX tapering is possible in those patients who have achieved a clinically important improvement from baseline status has not been demonstrated The iRAMT trial utilizes a prescribed strategy for infliximab dose titration in the event that individuals do not achieve a 40 improvement in the combined swollen and tender joint count or have a disease flare or recurrent worsening The iRAMT trial defines a clinically important improvement as at least a 40 improvement from baseline Once the 40 improvement is achieved MTX tapering will be initiated as appropriate for the specific patient The primary efficacy endpoint is the number of patients on a maintenance dose of infliximab who achieve at least 40 improvement from baseline in the combined tender and swollen joint count and tolerate any reduction in MTX dose at Week 54 Hence this trial will provide information regarding an infliximab dose titration strategy as well as a MTX tapering schedule in those patients responding to therapy The iRAMT trial will examine in a manner consistent with clinical practice if a schedule of infliximab maintenance will allow for tapering of MTX to occur Patients will receive Infliximab infusions at a minimum dose of 3 mgkg at Weeks 0 2 6 and every 8 weeks thereafter until Week 46 During the study the dose of infliximab may be increased by single 100-mg vials using a specified regimen up to a maximum of 10 mgkg every 4 weeks
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