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The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acthar Injectable Product
Depo medrol
Sponsored by
Attune Health Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    1. Joint must be tender
    2. Joint must be swollen
    3. Joint must have +2 or +3 doppler signal by ultrasound exam
    4. 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

Sites / Locations

  • Attune Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acthar

Depo Medrol

Arm Description

80 units of Acthar Injectable Product will be injected subcutaneously daily for three days, followed by twice weekly for four weeks.

40 milligrams of Depo Medrol will be injected intramuscularly one time

Outcomes

Primary Outcome Measures

Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment
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.
Initial degree of inflammation, as measured by a pathologist during histological assessment
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.

Secondary Outcome Measures

Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score)
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.
Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
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.
Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
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.
Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints
A clinician assesses 28 specified joints for tenderness and swelling.
Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints
A clinician assesses 28 specified joints for tenderness and swelling.
Number of tender and swollen joints after long-term treatment as measured by clinician while palpating 28 specified joints
A clinician assesses 28 specified joints for tenderness and swelling.
Initial Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h)
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.
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after short-term treatment
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.
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after long-term treatment
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.
Initial patient global health assessment measured by the patient (from 0=best to 100=worst)
A patient is asked to rate their general global health on a scale from 0 to 100
Patient global health assessment measured by the patient (from 0=best to 100=worst) after short-term treatment
A patient is asked to rate their general global health on a scale from 0 to 100
Patient global health assessment measured by the patient (from 0=best to 100=worst) after long-term treatment
A patient is asked to rate their general global health on a scale from 0 to 100

Full Information

First Posted
April 10, 2018
Last Updated
February 13, 2023
Sponsor
Attune Health Research, Inc.
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT03511625
Brief Title
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis
Official Title
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Attune Health Research, Inc.
Collaborators
Mallinckrodt

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acthar
Arm Type
Experimental
Arm Description
80 units of Acthar Injectable Product will be injected subcutaneously daily for three days, followed by twice weekly for four weeks.
Arm Title
Depo Medrol
Arm Type
Active Comparator
Arm Description
40 milligrams of Depo Medrol will be injected intramuscularly one time
Intervention Type
Drug
Intervention Name(s)
Acthar Injectable Product
Other Intervention Name(s)
repository corticotropin injection, H.P. Acthar Gel
Intervention Description
Acthar is a non-specific melanocortin receptor agonist
Intervention Type
Drug
Intervention Name(s)
Depo medrol
Other Intervention Name(s)
methylprednisolone acetate injectable suspension
Intervention Description
Depo medrol is an anti-inflammatory glucocorticoid
Primary Outcome Measure Information:
Title
Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment
Description
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.
Time Frame
Samples collected about 30 minutes before first treatment injection and about five days after this first injection
Title
Initial degree of inflammation, as measured by a pathologist during histological assessment
Description
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.
Time Frame
Samples collected about five days after first injection of treatment
Secondary Outcome Measure Information:
Title
Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score)
Description
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.
Time Frame
Assessments are performed about 1 hour before first treatment injection
Title
Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
Description
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.
Time Frame
Assessments are performed about 5 days after first treatment injection
Title
Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score)
Description
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.
Time Frame
Assessments are performed about 5-6 weeks after first treatment injection.
Title
Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints
Description
A clinician assesses 28 specified joints for tenderness and swelling.
Time Frame
Assessments are performed about 1 hour before first treatment injection
Title
Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints
Description
A clinician assesses 28 specified joints for tenderness and swelling.
Time Frame
Assessments are performed about 5 days after first treatment injection
Title
Number of tender and swollen joints after long-term treatment as measured by clinician while palpating 28 specified joints
Description
A clinician assesses 28 specified joints for tenderness and swelling.
Time Frame
Assessments are performed about 5-6 weeks after first treatment injection.
Title
Initial Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h)
Description
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.
Time Frame
Assessments are performed about 1 hour before first treatment injection
Title
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after short-term treatment
Description
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.
Time Frame
Assessments are performed about 5 days after first treatment injection
Title
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after long-term treatment
Description
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.
Time Frame
Assessments are performed about 5-6 weeks after first treatment injection.
Title
Initial patient global health assessment measured by the patient (from 0=best to 100=worst)
Description
A patient is asked to rate their general global health on a scale from 0 to 100
Time Frame
Assessments are performed about 1 hour before first treatment injection
Title
Patient global health assessment measured by the patient (from 0=best to 100=worst) after short-term treatment
Description
A patient is asked to rate their general global health on a scale from 0 to 100
Time Frame
Assessments are performed about 5 days after first treatment injection
Title
Patient global health assessment measured by the patient (from 0=best to 100=worst) after long-term treatment
Description
A patient is asked to rate their general global health on a scale from 0 to 100
Time Frame
Assessments are performed about 5-6 weeks after first treatment injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swamy R Venuturupalli, MD, FACR
Organizational Affiliation
CEO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Attune Health
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

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