ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ACTHAR
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rheumatoid arthritis; ACTHAR; Methotrexate; Inadequate response

Summary:

      Adenocorticotrophic Hormone provides safe and effective treatment to induce disease remission
      in rheumatoid arthritis patients with active disease due to an inadequate response to
      methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age at the time of screening

          -  Subject is diagnosed with RA no less than 6 months prior to the screening

          -  Subject meets the 2010 ACR/EULAR Classification Criteria for RA (Arthritis Rheum
             2010:62;2569-2581) with a score of ≥6

          -  Subject is seropositive for RF and/or anti-CCP antibodies as part of the diagnostic
             criteria for RA

          -  Subject has moderately to severely active RA during screening, as defined by a
             DAS28-ESR > 3.2

          -  Subject has moderately to severely active RA defined as the presence of at least 6/68
             tender joints and at least 6/66 swollen joints

          -  Subject has had an inadequate response to the continuous use of methotrexate for at
             least 12 weeks prior to study entry with a nonchanging dose for at least 8 weeks prior
             to study entry

        Exclusion Criteria:

          -  Treatment with any investigational agent within 4 weeks (or 5 half-lives of the
             investigational drug, whichever is longer) of screening

          -  Treatment with any biological agents within 4 weeks (or 5 half-lives of the agent,
             whichever is longer) of screening

          -  Immunization with a live/attenuated vaccine within 4 weeks prior to baseline

          -  Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary
             (including obstructive pulmonary disease), renal, hepatic, endocrine (including
             Cushing's disease or uncontrolled diabetes mellitus) or gastrointestinal disease
             (including complicated diverticulitis, ulcerative colitis, or Crohn's disease.)

          -  Current liver disease as determined by principal investigator unless related to
             primary disease under investigation

          -  Known active current or history of recurrent bacterial, viral, fungal, mycobacterial
             or other infections (including but not limited to tuberculosis and atypical
             mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding fungal
             infections of nail beds)

          -  Any major episode of infection requiring hospitalization or treatment with IV
             antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to
             screening

          -  Active TB requiring treatment within the previous 3 years. Patients should be screened
             for latent TB and, if positive, treated following local practice guidelines prior to
             initiating treatment. Patients treated for tuberculosis with no recurrence in 3 years
             are permitted.

          -  Evidence of active malignant disease, malignancies diagnosed within the previous 10
             years (including hematological malignancies and solid tumors, except basal and
             squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has
             been excised and cured), or breast cancer diagnosed within the previous 20 years
             unless related to primary disease under investigation

          -  Pregnant women or nursing (breast feeding) mothers

          -  Patients with reproductive potential not willing to use an effective method of
             contraception.

          -  History of alcohol, drug or chemical abuse within 1 year prior to screening.

          -  Neuropathies or other conditions that might interfere with pain evaluation unless
             related to primary disease under investigation.

          -  Body weight of > 150 kg

          -  Serum creatinine > 1.6 mg/dL (141 µmol/L) in female subjects and > 1.9 mg/dL (168
             µmol/L) in male subjects. Subjects with serum creatinine values exceeding limits may
             be eligible for the study if their estimated glomerular filtration rates (GFR) are >30

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times upper
             limit of normal (ULN)

          -  Total Bilirubin > ULN

          -  Platelet count < 100 x 109/L (100,000/mm3)

          -  Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)

          -  White Blood Cells < 3.0 x 109/L (3000/mm3)

          -  Absolute Neutrophil Count < 2.0 x 109/L (2000/mm3)

          -  Absolute Lymphocyte Count < 0.5 x 109/L (500/mm3)

          -  Positive Hepatitis BsAg or Hepatitis C antibody

          -  Major surgery (including joint surgery) within 8 weeks prior to screening or planned
             major surgery within 6 months following randomization

          -  A diagnosis of any of the followings: scleroderma, osteoporosis, infection throughout
             the body, ocular herpes simplex, history of or a current stomach ulcer, uncontrolled
             hypertension (systolic blood pressure greater than 160), or allergy to pig-derived
             proteins

          -  Subject does not tolerate methotrexate and/or NSAID due to side effects or toxicities