Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02434757
Status:
UNKNOWN
Last Update Posted:
2015-05-05
First Post:
2015-04-30
Brief Title:
Addition of HP Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis
Sponsor:
Ronald J Rapoport MD
Organization:
Phase III Clinical Research
Study Overview
Official Title:
Addition of H P Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis Inadequately Controlled With Biologic Disease-Modifying Antirheumatic Drugs
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
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 small study is to investigate the efficacy and safety of Acthar as an adjunct therapy in patients with active rheumatoid arthritis RA who have had an inadequate response to disease modifying antirheumatic drugs DMARDs and at least 3 biologic agents An in adequate response is defined as having 6 tender joints 6 swollen joints plus C-Reactive Protein CRP levels andor erythrocyte sedimentation rate ESR of 12 times the upper limit of normal in spite of aggressive treatment including 75 mgd prednisone This will be a 20 week prospective multicenter open-label study conducted at 3-4 universitymedical centers and private practice settings in the US A total of 20 eligible patients will be enrolled and other standard RA therapeutic agents such as Methotrexate DMARDs non-steroidal anti-inflammatory drugs NSAIDs pain medications and others will not be discontinued The primary endpoint will be the percentage of patients with reduction of 12 points of the Disease Activity Score in 28 joints DAS-28 score
Detailed Description:
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