Rheumatoid ArthritisPhase 4NCT03082573
Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel
A Phase 4 study testing H.P. Acthar gel in people with Rheumatoid Arthritis, run by Iraj Sabahi Research Inc. at 2 sites in United States.
Trial summary
This study will examine the clinical response, cytokine expression and joint imaging after addition of Acthar Gel. The hypothesis is that H.P. Acthar Gel is both safe and effective for treatment of patients with refractory rheumatoid arthritis (RA) and has different mechanism of action than steroids and other DMARDs. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- H.P. Acthar gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2017to Feb 2019
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of RA with incomplete or failure to treatment described as either A or B A: Failure to achieve remission or low disease activity within 3 to 6 months of treatment with combination of methotrexate or other DMARDs therapy with a biologic DMARD in maximally tolerated doses within the usual therapeutic range.
- B- A requirement, in addition to DMARDs and biologic DMARDs, for chronic glucocorticoid therapy in a dose of greater than about 5 to 7.5 mg/day of prednisone or equivalent to achieve or maintain remission or low disease activity after 3 to 6 months of treatment.
- Fluent in reading and writing in English language.
- ≥ 21 years of age at the time of participation.
Who cannot join
- Pregnancy
- Presence if contraindications for treatment with H.P. Acthar gel including but not limited to any known history of scleroderma, osteoporosis, systemic fungal infections, ocular Herpes Simplex, recent administration of live or live attenuated vaccine (prior 6 months), recent surgery (prior 6 months), history of or the presence of a peptic ulcer, primary adrenocortical insufficiency, adrenal cortical hyperfunction; congestive heart failure (defined as New York Hear Association Functional Class I to IV, uncontrolled hypertension.
- Previous use of ACTH preparations for treatment of nephrotic syndrome (including but not limited to H.P. Acthar gel and Synacthen®).
- Previous history of sensitivity to ACTH preparations (including but not limited to H.P. Acthar gel and Synacthen®).
- Previous history of sensitivity to porcine protein products.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Iraj Sabahi Research Inc
Pleasanton, California, 94588
Iraj Sabahi, MD, 925-264-7100, irajsabahi2015@gmail.com
Sonia Dimas, 209-634-3898, irajsabahi2015@gmail.com
- Recruiting
Iraj Sabahi Research Inc
Turlock, California, 95382
Iraj Sabahi, MD, 925-264-7100, irajsabahi2015@gmail.com
Sonia Dimas, 209-634-3898, irajsabahi2015@gmail.com
About this study
Official title: Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Were Treated With H.P. Acthar Gel After an Incomplete Response to Combinations of DMARDs and Biologic DMRADs
This study will examine the clinical response, cytokine expression and joint imaging after addition of Acthar Gel. The hypothesis is that H.P. Acthar Gel is both safe and effective for treatment of patients with refractory rheumatoid arthritis (RA) and has different mechanism of action than steroids and other DMARDs.
Read the detailed description
Rheumatoid arthritis (RA) is a systemic inflammatory disease which causes premature mortality, disability and compromised quality of life in the industrialized and developing world. The prevalence of RA is believed to range from 0.5-1.0% in the general population. Over the past half century, many studies have found mortality to be increased in patients with established RA in comparison with the general population. Despite available treatment options for RA, some patients still have disease that is refractory to treatment and cannot achieve remission.
H.P. Acthar gel (adrenocorticotropic hormone gel) received FDA approval for treatment of a variety of diseases, including RA in 1952. The proposed efficacy of H.P. Acthar gel has been attributed to its ability to induce production of endogenous steroids and to bind melanocortin receptors on lymphocytes and other cells to modulate immunologic responses. The present study will examine the clinical response, cytokine production and joint imaging after addition of H.P. Acthar gel to confirm the efficacy, confirm different mechanism of action in comparison to steroids and other DMARDs by looking for post treatment changes in cytokine expression.
- Conditions
- Rheumatoid Arthritis
- Being tested
- H.P. Acthar gel
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.P. Acthar gelDrug
Also called Repository Corticotropin Injection
H.P. Acthar gel in treatment of Refractory RA
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Will be receiving the same background medications and H.P. Acthar gel 40 units twice weekly for 12 weeks.
Patients in group A, can be cross over to group B on week 13 if disease is uncontrolled for continuation until week 24. If their disease is under control then they will continue with the same dosage until week 24.
If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion. Receives: Drug: H.P. Acthar gel |
| Group B | Active comparator | Will be receiving the same background medications and H.P. Acthar gel 80 units twice weekly for 12 weeks.
if the disease is not under control, will continue with same dosage until week 24. If the disease is under control, will be given the option to reduce the dosage to 40 units twice weekly only if patient is suffering from H.P. Acthar gel related adverse effects.
If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion. Receives: Drug: H.P. Acthar gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR 20 response ACR 20 response
Equal or greater than 20 % reduction in RA disease activity
Measured: Baseline to week 12
Secondary outcomes (9)
ACR 50 response
Equal or greater than 50 % reduction in RA disease activity
Measured: Baseline to week 24
ACR 70 response
Equal or greater than 70 % reduction in RA disease activity
Measured: Baseline to week 24
EULAR moderate response
Decline in the DAS 28 score by >1.2 (without reaching low disease activity) OR The decline of 0.6 to 1.2, plus reaching at least moderate disease activity (DAS28 <5.1).
Measured: Baseline to week 24
EULAR good response
Decline in DAS 28 score must exceed 1.2 and result in the achievement of low disease activity (DAS28 <3.2).
Measured: Baseline to week 24
Resolution of Powered Doppler Signal of MSKUS studies
Decline or resolution of synovitis detected in ultra sonographic examination of joints
Measured: Baseline to week 24
Resolution of signs of active inflammation in MRI
Decline or resolution of synovitis, tenosynovitis or bone edema detected in MRI examination of joints
Measured: Baseline to week 24
Reduction in Vectra DA Score
Decline in RA disease activity manifested as decline in Vectra DA Score
Measured: Baseline to week 24
Correlation between MSKUS and MRI Imaging findings
Comparison between MSKUS and MRI imaging
Measured: Baseline to week 24
Correlation between imaging findings and Vectra DA test
Comparison between MSKUS/MRI findings and Vectra DA test results
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start3 Mar 2017
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2019 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iraj Sabahi Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Iraj Sabahi, MD, Principal investigator, Iraj Sabahi Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082573
- Sponsor's protocol ID
- IS2017
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Were Treated With H.P. Acthar Gel After an Incomplete Response to Combinations of DMARDs and Biologic DMRADs
- ClinicalTrials.gov ID
- NCT03082573
- Acronym / sponsor ID
- IS2017
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Iraj Sabahi Research Inc.University, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 17 Mar 2017 (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.
This study will examine the clinical response, cytokine expression and joint imaging after addition of Acthar Gel. The hypothesis is that H.P. Acthar Gel is both safe and effective for treatment of patients with refractory rheumatoid arthritis (RA) and has different mechanism of action than steroids and other DMARDs.
Detailed description
Rheumatoid arthritis (RA) is a systemic inflammatory disease which causes premature mortality, disability and compromised quality of life in the industrialized and developing world. The prevalence of RA is believed to range from 0.5-1.0% in the general population. Over the past half century, many studies have found mortality to be increased in patients with established RA in comparison with the general population. Despite available treatment options for RA, some patients still have disease that is refractory to treatment and cannot achieve remission.
H.P. Acthar gel (adrenocorticotropic hormone gel) received FDA approval for treatment of a variety of diseases, including RA in 1952. The proposed efficacy of H.P. Acthar gel has been attributed to its ability to induce production of endogenous steroids and to bind melanocortin receptors on lymphocytes and other cells to modulate immunologic responses. The present study will examine the clinical response, cytokine production and joint imaging after addition of H.P. Acthar gel to confirm the efficacy, confirm different mechanism of action in comparison to steroids and other DMARDs by looking for post treatment changes in cytokine expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: H.P. Acthar gelWill be receiving the same background medications and H.P. Acthar gel 40 units twice weekly for 12 weeks. Patients in group A, can be cross over to group B on week 13 if disease is uncontrolled for continuation until week 24. If their disease is under control then they will continue with the same dosage until week 24. If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion. |
| Group B | Active comparator | Drug: H.P. Acthar gelWill be receiving the same background medications and H.P. Acthar gel 80 units twice weekly for 12 weeks. if the disease is not under control, will continue with same dosage until week 24. If the disease is under control, will be given the option to reduce the dosage to 40 units twice weekly only if patient is suffering from H.P. Acthar gel related adverse effects. If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with diagnosis of RA with incomplete or failure to treatment described as either A or B A: Failure to achieve remission or low disease activity within 3 to 6 months of treatment with combination of methotrexate or other DMARDs therapy with a biologic DMARD in maximally tolerated doses within the usual therapeutic range.
- B- A requirement, in addition to DMARDs and biologic DMARDs, for chronic glucocorticoid therapy in a dose of greater than about 5 to 7.5 mg/day of prednisone or equivalent to achieve or maintain remission or low disease activity after 3 to 6 months of treatment.
- Fluent in reading and writing in English language.
- ≥ 21 years of age at the time of participation.
Key exclusion criteria (5 listed)
- Pregnancy
- Presence if contraindications for treatment with H.P. Acthar gel including but not limited to any known history of scleroderma, osteoporosis, systemic fungal infections, ocular Herpes Simplex, recent administration of live or live attenuated vaccine (prior 6 months), recent surgery (prior 6 months), history of or the presence of a peptic ulcer, primary adrenocortical insufficiency, adrenal cortical hyperfunction; congestive heart failure (defined as New York Hear Association Functional Class I to IV, uncontrolled hypertension.
- Previous use of ACTH preparations for treatment of nephrotic syndrome (including but not limited to H.P. Acthar gel and Synacthen®).
- Previous history of sensitivity to ACTH preparations (including but not limited to H.P. Acthar gel and Synacthen®).
- Previous history of sensitivity to porcine protein products.
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 |
|---|---|---|
| H.P. Acthar gelAlso: Repository Corticotropin InjectionH.P. Acthar gel in treatment of Refractory RA | Drug | Group A, Group B |
Primary outcome
ACR 20 response ACR 20 response
Time frame: Baseline to week 12
Equal or greater than 20 % reduction in RA disease activity
9 secondary outcomes
ACR 50 response
Time frame: Baseline to week 24
ACR 70 response
Time frame: Baseline to week 24
EULAR moderate response
Time frame: Baseline to week 24
EULAR good response
Time frame: Baseline to week 24
Resolution of Powered Doppler Signal of MSKUS studies
Time frame: Baseline to week 24
Resolution of signs of active inflammation in MRI
Time frame: Baseline to week 24
Reduction in Vectra DA Score
Time frame: Baseline to week 24
Correlation between MSKUS and MRI Imaging findings
Time frame: Baseline to week 24
Correlation between imaging findings and Vectra DA test
Time frame: Baseline to week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Iraj Sabahi, MD principal investigator
Iraj Sabahi Research Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing H.P. Acthar gel in people with Rheumatoid Arthritis, run by Iraj Sabahi Research Inc. at 2 sites 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 4 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 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Iraj Sabahi, MD (925-264-7100, irajsabahi2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR 20 response ACR 20 response (time frame: Baseline to week 12). 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 17 Mar 2017.