Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-02 @ 7:17 AM
Study NCT ID:
NCT02434757
Status:
UNKNOWN
Last Update Posted:
2015-05-05
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis
Sponsor:
Ronald J. Rapoport, MD
Organization:
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 and/or erythrocyte sedimentation rate (ESR) of ≥ 1.2 times the upper limit of normal in spite of aggressive treatment, including ≥ 7.5 mg/d prednisone. This will be a 20 week, prospective, multicenter, open-label study conducted at 3-4 university/medical 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 ≥1.2 points of the Disease Activity Score in 28 joints (DAS-28) score.
Detailed Description:
\>
Study Oversight
Has Oversight DMC:
True
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?: