Rheumatoid ArthritisPhase 3NCT03511625
The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis
A Phase 3 study testing Acthar Injectable Product and Depo medrol in people with Rheumatoid Arthritis, run by Attune Health Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Acthar Injectable Product and Depo medrol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 3 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Acthar Injectable Product, Depo medrol
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar Injectable ProductDrug
Also called repository corticotropin injection, H.P. Acthar Gel
Acthar is a non-specific melanocortin receptor agonist
Depo medrolDrug
Also called methylprednisolone acetate injectable suspension
Depo medrol is an anti-inflammatory glucocorticoid
| Study group | Role | What they receive |
|---|---|---|
| Acthar | Experimental | 80 units of Acthar Injectable Product will be injected subcutaneously daily for three days, followed by twice weekly for four weeks. Receives: Drug: Acthar Injectable Product |
| Depo Medrol | Active comparator | 40 milligrams of Depo Medrol will be injected intramuscularly one time Receives: Drug: Depo medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Samples collected about five days after first injection of treatment
Secondary outcomes (12)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
A clinician assesses 28 specified joints for tenderness and swelling.
Measured: 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
A clinician assesses 28 specified joints for tenderness and swelling.
Measured: 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
A clinician assesses 28 specified joints for tenderness and swelling.
Measured: Assessments are performed about 5-6 weeks after first treatment injection.
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.
Measured: Assessments are performed about 1 hour before first treatment injection
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.
Measured: Assessments are performed about 5 days after first treatment injection
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.
Measured: 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)
A patient is asked to rate their general global health on a scale from 0 to 100
Measured: 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
A patient is asked to rate their general global health on a scale from 0 to 100
Measured: 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
A patient is asked to rate their general global health on a scale from 0 to 100
Measured: Assessments are performed about 5-6 weeks after first treatment injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start2 Oct 2018
- Primary completion26 Feb 2020
- Study completion3 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attune Health Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Swamy R Venuturupalli, MD, FACR, Principal investigator, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511625
- Sponsor's protocol ID
- 32971
- Status last verified
- Jan 2024
- First submitted
- 10 Apr 2018
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study
- ClinicalTrials.gov ID
- NCT03511625
- Acronym / sponsor ID
- 32971
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Attune Health Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mallinckrodt
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 3 Dec 2024 (estimated)
- First posted
- 30 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acthar | Experimental | Drug: Acthar Injectable Product80 units of Acthar Injectable Product will be injected subcutaneously daily for three days, followed by twice weekly for four weeks. |
| Depo Medrol | Active comparator | Drug: Depo medrol40 milligrams of Depo Medrol will be injected intramuscularly one time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acthar Injectable ProductAlso: repository corticotropin injection, H.P. Acthar GelActhar is a non-specific melanocortin receptor agonist | Drug | Acthar |
| Depo medrolAlso: methylprednisolone acetate injectable suspensionDepo medrol is an anti-inflammatory glucocorticoid | Drug | Depo Medrol |
Primary outcome
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.
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.
12 secondary outcomes
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
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
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.
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
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
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.
Initial Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h)
Time frame: 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
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.
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swamy R Venuturupalli, MD, FACR principal investigator
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acthar Injectable Product and Depo medrol in people with Rheumatoid Arthritis, run by Attune Health Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.