The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: corticotrophin 80 units
Intervention description: 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
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis

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.
    

Eligibility 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