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ACTHAR Gel for Rheumatoid Arthritis

N/A
Waitlist Available
Led By Larry W Moreland, MD
Research Sponsored by Dana Ascherman
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 12 weeks
Awards & highlights

Study Summary

This trial will help to evaluate the effectiveness of ACTH gel in decreasing the disease symptoms of people with RA who are already taking medications prescribed by their physician and are still experiencing disease symptoms.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
Secondary outcome measures
Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12
Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12
Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12
+1 more

Side effects data

From 2011 Phase 4 trial • 15 Patients • NCT01129284
40%
exacerbation of diabetes
20%
Increased skin pigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Membranous Nephropathy
IgA Nephropathy
FSGS/MCD

Trial Design

1Treatment groups
Experimental Treatment
Group I: ACTHAR GelExperimental Treatment1 Intervention
Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACTHAR gel
2014
Completed Phase 4
~40

Find a Location

Who is running the clinical trial?

MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,210 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
147 Patients Enrolled for Rheumatoid Arthritis
Dana AschermanLead Sponsor
Larry W Moreland, MDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ACTH Gel Therapy in Rheumatoid Arthritis
Dana Ascherman 2014. "ACTH Gel Therapy in Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02030028.
~2 spots leftby Apr 2025
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