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

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ClinicalTrials.gov Identifier: NCT03082573
Recruitment Status : Unknown
Verified March 2017 by Iraj Sabahi Research Inc..
Recruitment status was:  Recruiting
First Posted : March 17, 2017
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Iraj Sabahi Research Inc.

Tracking Information
First Submitted Date  ICMJE March 13, 2017
First Posted Date  ICMJE March 17, 2017
Last Update Posted Date March 17, 2017
Actual Study Start Date  ICMJE March 3, 2017
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
ACR 20 response ACR 20 response [ Time Frame: Baseline to week 12 ]
Equal or greater than 20 % reduction in RA disease activity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • ACR 50 response [ Time Frame: Baseline to week 24 ]
    Equal or greater than 50 % reduction in RA disease activity
  • ACR 70 response [ Time Frame: Baseline to week 24 ]
    Equal or greater than 70 % reduction in RA disease activity
  • 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).
  • 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).
  • 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
  • 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
  • Reduction in Vectra DA Score [ Time Frame: Baseline to week 24 ]
    Decline in RA disease activity manifested as decline in Vectra DA Score
  • Correlation between MSKUS and MRI Imaging findings [ Time Frame: Baseline to week 24 ]
    Comparison between MSKUS and MRI imaging
  • Correlation between imaging findings and Vectra DA test [ Time Frame: Baseline to week 24 ]
    Comparison between MSKUS/MRI findings and Vectra DA test results
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: H.P. Acthar gel
H.P. Acthar gel in treatment of Refractory RA
Other Name: Repository Corticotropin Injection
Study Arms  ICMJE
  • 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.

    Intervention: Drug: H.P. Acthar gel
  • 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.

    Intervention: Drug: H.P. Acthar gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 16, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03082573
Other Study ID Numbers  ICMJE IS2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Iraj Sabahi Research Inc.
Study Sponsor  ICMJE Iraj Sabahi Research Inc.
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE
Principal Investigator: Iraj Sabahi, MD Iraj Sabahi Research Inc.
PRS Account Iraj Sabahi Research Inc.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP