Back to resultsACTH Gel Therapy in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACTHAR gel
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, ACTH gel
Eligibility Criteria
Inclusion Criteria:
- 18 year of age and older
- RA diagnosis by American College of Rheumatology criteria
- Active disease (CDAI > 10)
- Have received at least are biologic agent for at least 6 months
- May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
- No current active infections requiring antibiotics
- Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA therapies for at least 4 weeks prior to baseline visit)
Exclusion Criteria:
- Less than 18 years of age
- Unable or unwilling to give Informed Consent
- Have an active infection requiring the use of antibiotics
- Women who are pregnant
- Uncontrolled hypertension
- Abnormal renal function
- Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and aspartate aminotransferase (AST) that is greater than 5 times normal.
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ACTHAR Gel
Arm Description
Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.
Outcomes
Primary Outcome Measures
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
percentage of participants achieving >20% improvement in CDAI after 12 weeks of therapy (>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 < 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity)
Secondary Outcome Measures
Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12
Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement.
Scale: 0-8.61 (lower scores indicate reduced disease activity)
Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12
Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP < 0))
Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12
Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS < 0)
Patient Reported Changes in Fatigue Between Week 0 and Week 12
The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue.
Full Information
NCT ID
NCT02030028
First Posted
January 6, 2014
Last Updated
August 12, 2023
Sponsor
Dana Ascherman
Collaborators
Mallinckrodt
1. Study Identification
Unique Protocol Identification Number
NCT02030028
Brief Title
ACTH Gel Therapy in Rheumatoid Arthritis
Official Title
Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dana Ascherman
Collaborators
Mallinckrodt
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms.
ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.
Detailed Description
This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each week for 12 weeks as a supplement to current therapies. Subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a blood sample for research purposes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, ACTH gel
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACTHAR Gel
Arm Type
Other
Arm Description
Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.
Intervention Type
Drug
Intervention Name(s)
ACTHAR gel
Other Intervention Name(s)
Adrenocorticotropic hormone
Intervention Description
Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.
Primary Outcome Measure Information:
Title
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
Description
percentage of participants achieving >20% improvement in CDAI after 12 weeks of therapy (>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 < 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12
Description
Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement.
Scale: 0-8.61 (lower scores indicate reduced disease activity)
Time Frame
12 weeks
Title
Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12
Description
Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP < 0))
Time Frame
12 weeks
Title
Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12
Description
Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS < 0)
Time Frame
12 weeks
Title
Patient Reported Changes in Fatigue Between Week 0 and Week 12
Description
The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 year of age and older
RA diagnosis by American College of Rheumatology criteria
Active disease (CDAI > 10)
Have received at least are biologic agent for at least 6 months
May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent
No current active infections requiring antibiotics
Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA therapies for at least 4 weeks prior to baseline visit)
Exclusion Criteria:
Less than 18 years of age
Unable or unwilling to give Informed Consent
Have an active infection requiring the use of antibiotics
Women who are pregnant
Uncontrolled hypertension
Abnormal renal function
Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and aspartate aminotransferase (AST) that is greater than 5 times normal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry W Moreland, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
12. IPD Sharing Statement
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ACTH Gel Therapy in Rheumatoid Arthritis
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