- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03511625
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis
January 29, 2024 updated by: Attune Health Research, Inc.
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study
Patients will be assigned to receive either Depo Medrol or Acthar treatment.
A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients will be assigned to receive either Depo Medrol or Acthar treatment.
A synovial biopsy, blood draws, synovial fluid aspiration, and physician assessments will be performed before and after initiating treatment.
At screening visit, inclusion and exclusion criteria will be assessed.
If assessments have not been completed to verify these criteria, they will be performed at this visit.
After patients are confirmed to meet criteria, patient disease activity will be assessed and blood draw, synovial aspiration, and biopsy will be performed before first treatment injection.
About 5 days after this first treatment injection, these assessment and samples will be performed again.
About 5-6 weeks after first treatment injection, a final physician assessment will be performed.
Patients will have the option of consenting to allow storage of samples for future research.
Study Type
Interventional
Enrollment (Estimated)
6
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90211
- Attune Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Anti-Cyclic Citrullinated Peptide positive rheumatoid arthritis
- on a stable regimen of medications
- moderate to severe disease activity as measured by the Clinical Disease activity index (CDAI), or DAS28 (Disease Activity Score) within 30 days of starting the study
Patients must have at least one joint with the following features within 30 days of starting the study:
- Joint must be tender
- Joint must be swollen
- Joint must have +2 or +3 doppler signal by ultrasound exam
- Joint must have +2 or +3 gray scale synovitis by ultrasound exam e. Joint must be amenable to synovial biopsy.
f. Clinician assessing the joint must conclude, with a reasonable degree of certainty, that the swelling and tenderness observed in the joint is caused by rheumatoid arthritis, and not by another arthritic condition such as osteoarthritis, crystal arthritis, or infection.
Exclusion Criteria:
- Patients on anti-coagulation therapy
- Patients with an active infection
- Patients receiving oral corticosteroids within 5 days of enrollment, or parenteral corticosteroids within 3 weeks of enrollment (unless deemed able to taper off medication under investigator oversight and supervision)
- Patients with any history of joint infection
- Patients with a history of tuberculosis or coccidioidomycosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acthar
80 units of Acthar Injectable Product will be injected subcutaneously daily for three days, followed by twice weekly for four weeks.
|
Acthar is a non-specific melanocortin receptor agonist
Other Names:
|
Active Comparator: Depo Medrol
40 milligrams of Depo Medrol will be injected intramuscularly one time
|
Depo medrol is an anti-inflammatory glucocorticoid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment
Time Frame: Samples collected about 30 minutes before first treatment injection and about five days after this first injection
|
Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear.
|
Samples collected about 30 minutes before first treatment injection and about five days after this first injection
|
Initial degree of inflammation, as measured by a pathologist during histological assessment
Time Frame: Samples collected about five days after first injection of treatment
|
Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear.
|
Samples collected about five days after first injection of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score)
Time Frame: Assessments are performed about 1 hour before first treatment injection
|
In DAS28, a clinician assesses 28 specified joints for tenderness and swelling.
A blood draw is performed at time of assessment to measure Erythrocyte Sedimentation Rate (in mm/h).
The patient global health assessment (from 0=best to 100=worst) is also used.
A specific algorithm is used to calculate the DAS28 score, using the measurements obtained as variables that plug into the algorithm.
|
Assessments are performed about 1 hour before first treatment injection
|
Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
Time Frame: Assessments are performed about 5 days after first treatment injection
|
In DAS28, a clinician assesses 28 specified joints for tenderness and swelling.
A blood draw is performed at time of assessment to measure Erythrocyte Sedimentation Rate (in mm/h).
The patient global health assessment (from 0=best to 100=worst) is also used.
A specific algorithm is used to calculate the DAS28 score, using the measurements obtained as variables that plug into the algorithm.
|
Assessments are performed about 5 days after first treatment injection
|
Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
Time Frame: Assessments are performed about 5-6 weeks after first treatment injection.
|
In DAS28, a clinician assesses 28 specified joints for tenderness and swelling.
A blood draw is performed at time of assessment to measure Erythrocyte Sedimentation Rate (in mm/h).
The patient global health assessment (from 0=best to 100=worst) is also used.
A specific algorithm is used to calculate the DAS28 score, using the measurements obtained as variables that plug into the algorithm.
|
Assessments are performed about 5-6 weeks after first treatment injection.
|
Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints
Time Frame: Assessments are performed about 1 hour before first treatment injection
|
A clinician assesses 28 specified joints for tenderness and swelling.
|
Assessments are performed about 1 hour before first treatment injection
|
Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints
Time Frame: Assessments are performed about 5 days after first treatment injection
|
A clinician assesses 28 specified joints for tenderness and swelling.
|
Assessments are performed about 5 days after first treatment injection
|
Number of tender and swollen joints after long-term treatment as measured by clinician while palpating 28 specified joints
Time Frame: Assessments are performed about 5-6 weeks after first treatment injection.
|
A clinician assesses 28 specified joints for tenderness and swelling.
|
Assessments are performed about 5-6 weeks after first treatment injection.
|
Initial Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h)
Time Frame: Assessments are performed about 1 hour before first treatment injection
|
The Westergren method requires collecting 2 ml of venous blood into a tube containing 0 .5 ml of sodium citrate.
It should be stored no longer than 2 hours at room temperature or 6 hours at 4 °C.
The blood is drawn into a Westergren-Katz tube to the 200 mm mark.
The tube is placed in a rack in a strictly vertical position for 1 hour at room temperature, at which time the distance from the lowest point of the surface meniscus to the upper limit of the red cell sediment is measured.
The distance of fall of erythrocytes, expressed as millimeters in 1 hour, is the Erythrocyte Sedimentation Rate.
|
Assessments are performed about 1 hour before first treatment injection
|
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after short-term treatment
Time Frame: Assessments are performed about 5 days after first treatment injection
|
The Westergren method requires collecting 2 ml of venous blood into a tube containing 0 .5 ml of sodium citrate.
It should be stored no longer than 2 hours at room temperature or 6 hours at 4 °C.
The blood is drawn into a Westergren-Katz tube to the 200 mm mark.
The tube is placed in a rack in a strictly vertical position for 1 hour at room temperature, at which time the distance from the lowest point of the surface meniscus to the upper limit of the red cell sediment is measured.
The distance of fall of erythrocytes, expressed as millimeters in 1 hour, is the Erythrocyte Sedimentation Rate.
|
Assessments are performed about 5 days after first treatment injection
|
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after long-term treatment
Time Frame: Assessments are performed about 5-6 weeks after first treatment injection.
|
The Westergren method requires collecting 2 ml of venous blood into a tube containing 0 .5 ml of sodium citrate.
It should be stored no longer than 2 hours at room temperature or 6 hours at 4 °C.
The blood is drawn into a Westergren-Katz tube to the 200 mm mark.
The tube is placed in a rack in a strictly vertical position for 1 hour at room temperature, at which time the distance from the lowest point of the surface meniscus to the upper limit of the red cell sediment is measured.
The distance of fall of erythrocytes, expressed as millimeters in 1 hour, is the Erythrocyte Sedimentation Rate.
|
Assessments are performed about 5-6 weeks after first treatment injection.
|
Initial patient global health assessment measured by the patient (from 0=best to 100=worst)
Time Frame: Assessments are performed about 1 hour before first treatment injection
|
A patient is asked to rate their general global health on a scale from 0 to 100
|
Assessments are performed about 1 hour before first treatment injection
|
Patient global health assessment measured by the patient (from 0=best to 100=worst) after short-term treatment
Time Frame: Assessments are performed about 5 days after first treatment injection
|
A patient is asked to rate their general global health on a scale from 0 to 100
|
Assessments are performed about 5 days after first treatment injection
|
Patient global health assessment measured by the patient (from 0=best to 100=worst) after long-term treatment
Time Frame: Assessments are performed about 5-6 weeks after first treatment injection.
|
A patient is asked to rate their general global health on a scale from 0 to 100
|
Assessments are performed about 5-6 weeks after first treatment injection.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Swamy R Venuturupalli, MD, FACR, CEO
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 2, 2018
Primary Completion (Actual)
February 26, 2020
Study Completion (Estimated)
December 3, 2024
Study Registration Dates
First Submitted
April 10, 2018
First Submitted That Met QC Criteria
April 26, 2018
First Posted (Actual)
April 30, 2018
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Inflammation
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Adrenocorticotropic Hormone
Other Study ID Numbers
- 32971
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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