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Corticosteroid

H.P. Acthar Gel SQ injection for Psoriatic Arthritis

Phase 4
Waitlist Available
Research Sponsored by Fiechtner, Justus J., M.D., P.C.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

Psoriatic arthritis is a heterogeneous chronic inflammatory disorder involving joints, tendon sheaths, entheses, and the axial skeleton as well as skin and nails. This is an open-label trial with H.P. Acthar Gel (80 units/1mL) Subcutaneous injection administered twice weekly. To evaluate the signs and symptoms of psoriatic arthritis after 12 weeks, including American College of Rheumatology 20,Clinical Disease Activity Index, Disease Activity Index 28, Dactylitis and adverse events.

Eligible Conditions
  • Psoriatic Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ACR20 (American College of Rheumatology 20)
Secondary study objectives
Adverse Events
Other study objectives
Dactylitis (Digit Inflammation)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: H.P. Acthar Gel SQ injectionExperimental Treatment1 Intervention
Open-label H.P. Acthar Gel 80 units subcutaneously twice weekly for 12 weeks with a 12 week extension.

Find a Location

Who is running the clinical trial?

MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,856 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
10 Patients Enrolled for Psoriatic Arthritis
Fiechtner, Justus J., M.D., P.C.Lead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
~1 spots leftby Nov 2025
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