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The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients

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ClinicalTrials.gov Identifier: NCT01948388
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Gaylis, Norman B., M.D.

Brief Summary:
The purpose of the study is to evaluate the effect of the utilization of two doses of corticotrophin ( ACTH) as a treatment in patients with early onset rheumatoid arthritis as an alternative to conventional steroid therapy by evaluating the change from baseline in the clinical findings as well as the structural findings on Magnetic Resonance Imaging (MRI). Corticotrophin (ACTH) may prevent the well documented structural progression damage in RA patients using disease-modifying antirheumatic drug (DMARD) therapy alone.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: corticotrophin 80 units Phase 4

Detailed Description:
This is a Phase II 24-week open-label study to evaluate the efficacy and safety of H.P. Acthar Gel Respository Injection, Corticotrophin( ACTH) administered to newly diagnosed patients with rheumatoid arthritis in conjunction with methotrexate, folllowed by a 24 week follow-up period. There will be a total of twenty (20) patients and two (2) treatment groups with 10 patients in each treatment group

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of The Effect of Corticotrophin in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients From a Clinical and Structural Perspective As Measured by a Clinical Disease Activity Index Score and Bone Edema, Synovitis and Erosions on Magnetic Resonance Imaging
Study Start Date : September 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Active Comparator: corticotrophin 80 units
Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) weekly
Drug: corticotrophin 80 units
Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin
Other Name: Acthar, Corticotrophin, ACTH

Active Comparator: corticotrophin 80 units twice a week
Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) twice a week
Drug: corticotrophin 80 units
Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin
Other Name: Acthar, Corticotrophin, ACTH




Primary Outcome Measures :
  1. Clinical Disease Activity Index (CDAI) score Evaluation [ Time Frame: Baseline, Month 3 and Month 6 ]
    The primary objective would be to evaluate the effect of the utilization of two doses of corticotrophin (ACTH) as a treatment in patients with early onset rheumatoid arthritis as an alternative to conventional steroid therapy by evaluating the change from baseline in the clinical findings as measured by Clinical Disease Activity Index (CDAI) scores


Secondary Outcome Measures :
  1. Evaluation of MRI structural improvements [ Time Frame: 3 months, 6 months ]
    To measure and record the change from baseline in the presence of synovitis and bone edema at months 3 and 6

  2. Change from baseline in erosions as measured by Magnetic Resonance Imaging (MRI) [ Time Frame: Month 3, Month 6 ]
    Comparison of the change in erosion scores as measured by Magnetic Resonance Imaging (MRI) findings

  3. Number of patients at months 3 and 6 without new bone erosions and/or joint space narrowing on MRI and X-ray [ Time Frame: Month 3 and Month 6 ]
    Record the number of patients without new bone erosions and/or joint space narrowing as measured on Magnetic Resonance Imaging (MRI) and X-ray

  4. Measurement of the number of patients who reach American College of Rheumatology (ACR) remission at defined levels (20%, 50%, 70%) [ Time Frame: Month 3 and Month 6 ]
    Calculate the number of patients who reach American College of Rheumatology (ACR)remission of 20%, 50% and 70% using the ACR scoring system

  5. Comparison of Clinical Disease Activity Index (CDAI) scores to positive Magnetic Resonance Imaging (MRI) findings [ Time Frame: Baseline, Month 3 and Month 6 ]
    Comparison of the clinical findings as measured by the Clinical Disease Activity Index (CDAI) versus the positive structural findings as measured by Magnetic Resonance Imaging (MRI)

  6. Correlation of changes in Magnetic Resonance Imaging (MRI) scores with changes in van der Heijde Sharp(VdH Sharp)X-ray scores [ Time Frame: Month 3 and Month 6 ]
    Correlation of the changes in the Magnetic Resonance Imaging (MRI) scoring versus the X-ray scoring system

  7. Comparison of the clinical laboratory results with the positive Magnetic Resonance Imaging (MRI) findings [ Time Frame: Baseline, Month 3 and Month 6 ]
    Comparison of the clinical laboratory test results of Rheumatoid Factor (RF), anti-citrullinated protein antibody (anti-CCP antibody), C-reactive protein (CRP), and sedimentation rate (ESR)versus the positive structural findings on Magnetic Resonance Imaging (MRI)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must be at least 18 years old at the screening visit.
  2. Patient must be able to understand the information provided to them and to give written Informed Consent.
  3. Female patients must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, Intrauterine Device (IUD), or barrier and spermicide). Abstinence only is not an acceptable method. Patients must agree to use adequate contraception during the study and for 4 weeks after their last dose of corticotrophin (ACTH). Male patients must agree to ensure they or their female partner(s) are using adequate contraception during the study and for 4 weeks after the patient receives their last dose of corticotrophin (ACTH).
  4. Patients must have a new diagnosis of adult-onset rheumatoid arthritis (RA) as defined by the 2010 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria and who have had symptoms for <1 year.
  5. Patients must be experiencing mild to moderate rheumatoid arthritis ( RA), have at least 6 tender and 6 swollen joints at screening and a clinical disease activity index (CDAI) score of > 6.0
  6. A Baseline Magnetic Resonance Imaging ( MRI) must show the presence of osteitis or erosions in the hand or wrist.
  7. Patients must be able and willing to comply with the requirements of the study protocol.
  8. Patients must have a C-reactive Protein (CRP) or erythrocyte sedimentation rate (ESR) > upper limits of normal

Exclusion criteria:

  1. Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
  2. Patients with exposure to any disease modifying antirheumatic drug (DMARD), Biologic, Non-biologic or experimental medication for the treatment of rheumatoid arthritis (RA).
  3. Patients with a non-inflammatory type of arthritis (e.g. osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the patient's primary diagnosis of rheumatoid arthritis (RA).
  4. Patients with history of an infected joint prosthesis at any time with that prosthesis still in situ.
  5. Patients have received prohibited medication:

    • non-steroidal anti-inflammatory drug (NSAIDs /COX-2 inhibitors) (any change in dose regimen in the 7 days prior to baseline)
    • Oral corticosteroids within 4 weeks of baseline
    • Intra-muscular, intra-venous, intra-articular (IM/IV/IA) corticosteroids/ Intra-articular (IA) Hyaluronic acid (any dose 28 days prior to baseline)
  6. Female patients who are breast-feeding, pregnant, or plan to become pregnant during the trial or within twelve weeks following last dose of study drug.
  7. Patients with a history of chronic infection due to fungal, parasitic or mycotic pathogens during the preceding year, recent serious or life-threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection.
  8. Patients with active Tuberculosis (TB) (or history of active TB), positive chest X-ray for TB, or positive (defined as induration of ≥ 5mm) purified protein derivative (PPD) skin test, positive QuantiFERON, or patients having close contact with an individual with active TB. Patients having a PPD skin test ≥ 5 mm or a positive QuantiFERON test can enter the study, provided that active TB is excluded and provided that they are adequately treated for latent TB (e.g., isonicotinic acid hydrazide [INH therapy] for 9 months [with vitamin B6]) and provided that appropriate treatment is initiated simultaneously with the first administration of ACTH.
  9. Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bedridden or wheelchair bound).
  10. Patients with a known allergy or intolerance to steroids 11 Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than 5 years prior to screening).

12. Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease.

13. Patients with class III or IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria.

14. Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).

15. Patients with any other condition (e.g. clinically significant laboratory values) which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.

16. Patients who have a metal device affected by MRI (e.g., any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted cardioverter defibrillator; or a cochlear implant) 17. Patients who have a potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) for which they have sought medical attention.

18. Concurrent steroid use for any concomitant disease. 19. Subjects who are known to be Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C positive


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): NCT01948388


Locations
United States, Florida
AARDS Research, Inc
Aventura, Florida, United States, 33180
Sponsors and Collaborators
Gaylis, Norman B., M.D.
Investigators
Principal Investigator: Norman B Gaylis, MD AARDS Research, Inc.

Responsible Party: Gaylis, Norman B., M.D.
ClinicalTrials.gov Identifier: NCT01948388     History of Changes
Other Study ID Numbers: RA2013-01
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Gaylis, Norman B., M.D.:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adrenocorticotropic Hormone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists