ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03082573
Previous Study | Return to List | Next Study

Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03082573
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Iraj Sabahi Research Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: H.P. Acthar gel Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
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
Actual Study Start Date : March 3, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A

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.

Drug: H.P. Acthar gel
H.P. Acthar gel in treatment of Refractory RA
Other Name: Repository Corticotropin Injection

Active Comparator: Group B

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.

Drug: H.P. Acthar gel
H.P. Acthar gel in treatment of Refractory RA
Other Name: Repository Corticotropin Injection




Primary Outcome Measures :
  1. ACR 20 response ACR 20 response [ Time Frame: Baseline to week 12 ]
    Equal or greater than 20 % reduction in RA disease activity


Secondary Outcome Measures :
  1. ACR 50 response [ Time Frame: Baseline to week 24 ]
    Equal or greater than 50 % reduction in RA disease activity

  2. ACR 70 response [ Time Frame: Baseline to week 24 ]
    Equal or greater than 70 % reduction in RA disease activity

  3. EULAR moderate response [ Time Frame: Baseline to week 24 ]
    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).

  4. EULAR good response [ Time Frame: Baseline to week 24 ]
    Decline in DAS 28 score must exceed 1.2 and result in the achievement of low disease activity (DAS28 <3.2).

  5. Resolution of Powered Doppler Signal of MSKUS studies [ Time Frame: Baseline to week 24 ]
    Decline or resolution of synovitis detected in ultra sonographic examination of joints

  6. Resolution of signs of active inflammation in MRI [ Time Frame: Baseline to week 24 ]
    Decline or resolution of synovitis, tenosynovitis or bone edema detected in MRI examination of joints

  7. Reduction in Vectra DA Score [ Time Frame: Baseline to week 24 ]
    Decline in RA disease activity manifested as decline in Vectra DA Score

  8. Correlation between MSKUS and MRI Imaging findings [ Time Frame: Baseline to week 24 ]
    Comparison between MSKUS and MRI imaging

  9. Correlation between imaging findings and Vectra DA test [ Time Frame: Baseline to week 24 ]
    Comparison between MSKUS/MRI findings and Vectra DA test results



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. Fluent in reading and writing in English language.
  3. ≥ 21 years of age at the time of participation.

Exclusion Criteria:

  1. Pregnancy
  2. 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.
  3. Previous use of ACTH preparations for treatment of nephrotic syndrome (including but not limited to H.P. Acthar gel and Synacthen®).
  4. Previous history of sensitivity to ACTH preparations (including but not limited to H.P. Acthar gel and Synacthen®).
  5. Previous history of sensitivity to porcine protein products.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082573


Contacts
Contact: Iraj Sabahi, MD 925-264-7100 irajsabahi2015@gmail.com
Contact: Sonia Dimas 209-634-3898 irajsabahi2015@gmail.com

Locations
United States, California
Iraj Sabahi Research Inc Recruiting
Pleasanton, California, United States, 94588
Contact: Iraj Sabahi, MD    925-264-7100    irajsabahi2015@gmail.com   
Contact: Sonia Dimas    209-634-3898    irajsabahi2015@gmail.com   
Iraj Sabahi Research Inc Recruiting
Turlock, California, United States, 95382
Contact: Iraj Sabahi, MD    925-264-7100    irajsabahi2015@gmail.com   
Contact: Sonia Dimas    209-634-3898    irajsabahi2015@gmail.com   
Sponsors and Collaborators
Iraj Sabahi Research Inc.
Mallinckrodt
Investigators
Principal Investigator: Iraj Sabahi, MD Iraj Sabahi Research Inc.

Responsible Party: Iraj Sabahi Research Inc.
ClinicalTrials.gov Identifier: NCT03082573     History of Changes
Other Study ID Numbers: IS2017
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs