Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-01 @ 10:58 AM
Study NCT ID:
NCT03419650
Status:
COMPLETED
Last Update Posted:
2021-08-31
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Impact of Acthar in the Psoriatic Arthritis Patient (CLIPS)
Sponsor:
IRIS Research and Development, LLC
Organization:
Study Overview
Official Title:
Clinical Impact of Acthar in the Psoriatic Arthritis Patient (CLIPS)
Status:
COMPLETED
Status Verified Date:
2021-08
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:
CLIPS
Brief Summary:
Demonstrate the clinical value of Acthar TM in patients with active Psoriatic Arthritis who lack adequate response to DMARDS, and the quantification of response by clinical, serologic and structural parameters.
Detailed Description:
The study is an investigator initiated study (IIS) single arm treatment, single center where patients will receive active treatment with ActharTM 80 units twice weekly for 4 weeks followed by 40 units twice weekly until week 12.
2-End points:
1.Primary Clinical Endpoint
1\. To demonstrate the efficacy of Acthar for the treatment of patients with active psoriatic arthritis and who have not had an adequate response to non-biological DMARDs based on the proportion of subjects achieving a 20% improvement in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, Health Assessment Questionnaire (HAQ), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP) as described by American College of Rheumatology (ACR) 20 at week 12.
\[Time Frame: 12 weeks\]
2.Primary Imaging Endpoints
1. The improvement of the total DEMRIQ\*-Volume score of synovial inflammation measured in the Metacarpophalangeal (MCP), proximal interphalangeal (PIP) and the distal interphalangeal (DIP) joints. \[Time Frame: baseline to week 24\]
\[Time Frame: baseline to week 24\]
2. Secondary Outcome Measures:
Secondary Imaging Endpoints
1\. The improvement in PSAMRIS\* Synovitis score in the Metacarpophalangeal (MCP), proximal interphalangeal (PIP) and the distal interphalangeal (DIP) joints. \[Time Frame: baseline to week 24\]
\[Time Frame: baseline to week 24\]
2-End points:
1.Primary Clinical Endpoint
1\. To demonstrate the efficacy of Acthar for the treatment of patients with active psoriatic arthritis and who have not had an adequate response to non-biological DMARDs based on the proportion of subjects achieving a 20% improvement in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, Health Assessment Questionnaire (HAQ), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP) as described by American College of Rheumatology (ACR) 20 at week 12.
\[Time Frame: 12 weeks\]
2.Primary Imaging Endpoints
1. The improvement of the total DEMRIQ\*-Volume score of synovial inflammation measured in the Metacarpophalangeal (MCP), proximal interphalangeal (PIP) and the distal interphalangeal (DIP) joints. \[Time Frame: baseline to week 24\]
\[Time Frame: baseline to week 24\]
2. Secondary Outcome Measures:
Secondary Imaging Endpoints
1\. The improvement in PSAMRIS\* Synovitis score in the Metacarpophalangeal (MCP), proximal interphalangeal (PIP) and the distal interphalangeal (DIP) joints. \[Time Frame: baseline to week 24\]
\[Time Frame: baseline to week 24\]
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: