Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299546
Status:
COMPLETED
Last Update Posted:
2014-02-27
First Post:
2006-03-03
Brief Title:
A Study of the Safety and Efficacy of Golimumab CNTO 148 in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agents
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Trial of Golimumab a Fully Human Anti-TNFa Monoclonal Antibody Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agents
Status:
COMPLETED
Status Verified Date:
2014-01
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 this study is to evaluate the efficacy and safety of golimumab CNTO 148 in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent etanercept adalimumab or infliximab
Detailed Description:
Golimumab is a fully human protein antibody which binds to tumor necrosis factor-alpha TNFa TNFa is increased in patients with rheumatoid arthritis RA and plays a major role in causing the joint pain swelling and damage from RA Other marketed drugs that target TNFa anti-TNFa drugs have been shown to be effective in reducing the symptoms signs and joint damage of RA but have limitations with respect to safety and ease of use This is a randomized double-blind placebo-controlled trial of the efficacy and safety of a new anti-TNFa drug golimumab at 2 doses injected under the skin every 4 weeks in subjects with active RA previously treated with at least 1 dose of a biologic anti-TNFa agent etanercept adalimumab or infliximab Concomitant therapy with methotrexate sulfasalazine andor hydroxychloroquine is permitted if the subject has tolerated these medications for at least 12 weeks prior to the first administration of study drug and is on a stable dose for at least 4 weeks prior to the first administration of study agent The study hypothesis is that golimumab will be a safe and effective treatment for RA in subjects with active RA previously treated with at least one biologic anti-TNFa agent as measured by the American College of Rheumatology ACR response criteria the Disease Activity Score 28 DAS28 responses and the change from baseline in Health Assessment Questionnaire HAQ without causing unacceptable significant adverse effects The ACR response criteria were designed to assess the level of improvement in the signs and symptoms of RA The DAS28 responses also measure improvement in the signs and symptoms of RA using the joint examination and laboratory testing The HAQ is a series of questions that measure a subjects impairment in physical function caused by RA Patients will receive golimumab 50 mg or 100 mg or placebo injections under the skin every 4 weeks until Week 24 After Week 24 all subjects receive golimumab 50 mg or 100 mg injections and golimumab continues for all groups every 4 weeks for about 4 and a half more years
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 |
|---|---|---|---|
| C0524T11 | OTHER | Centocor | None |