
    difficulties to enrol patients
  
['psoriatic arthritis']
['fp187', 'placebo']

        Inclusion Criteria:

          -  documented clinical diagnosis of mild to moderate psoriatic arthritis of at least 3
             months

          -  active psoriatic arthritis with at least 2 tender and 2 swollen joints

          -  signed informed consent

          -  willingness and ability to comply with study procedures

          -  besides psoriatic arthritis, patient must be in good general health in the opinion of
             the investigator, as determined by medical history, physical examination, vital signs,
             electrocardiography and clinical laboratory parameters

          -  if patients are using methotrexate, they should be on a stable dosis of not more the
             20mg per week for at least 90 days prior to study entrance and should present no
             serious toxic side effects attributable to methotrexate

          -  female of childbearing age must be either surgically sterile or use a highly effective
             medically accepted contraceptive method

        Exclusion Criteria:

          -  female patients who are pregnant of breast-feeding or planning to become pregnant
             during the entire trial period

          -  male patients planning pregnancy with their partner during the entire trial period, or
             practicing unprotected sexual relationship during the entire trial period

          -  known allergy to any of the constituents of the products being tested

          -  known immunosuppressive diseases (e.g. HIV, AIDS)

          -  known history of latent or active granulomatous infection including tuberculosis,
             histoplasmosis or coccidioidomycosis

          -  presence of another inflammatory disease including but not limited to rheumatoid
             arthritis, ankylosing spondylitis, systemic lupus erythematous or Lyme disease

          -  presence of chronic widespread pain syndrome

          -  patients with pustular forms of psoriasis, erythrodermic or guttate psoriasis

          -  patients with another non-psoriatic arthropathy (e.g. osteoarthritis)

          -  presence of another serious or progressive disease including skin malignancy

          -  presence or history of any malignancy (except for basal cell carcinoma, squamous cell
             carcinoma in situ of the skin treated with no evidence of recurrence within 5 years,
             or cervix cancer in situ treated with no evidence of recurrence.)

          -  use at any time of an biological Disease Modifying Antirheumatic Drug (bDMARD) such as
             etanercept, adalimumab, golimumab, certolizumab pegol or infliximab

          -  corticosteroid injections within 12 weeks

          -  use of any dimethyl fumarate (DMF) containing product within 12 weeks

          -  use of any retinoid treatments, other immunosuppressive treatments, cytostatics or
             drugs with known harmful effects on the kidneys within the last 3 months

          -  use of cyclosporine, corticosteroids or psoralen + UVA (PUVA) treatment within 4 weeks

          -  ongoing stomach or intestinal problems (e.g. gastritis or peptic ulcer)

          -  Aspartate transaminase (AST) or Alanine transaminase (ALT) > 2x upper normal normal
             limit (UNL) or Gamma Glutamyl Transferase (gamma-GT) results >2.5 UNL

          -  estimated creatinine clearance (Cockcroft-Gault) < 60ml/min

          -  leucopenia (leucocyte count < 3.5/nl), eosinophilia (>750 / micro l) or
             lymphocytopenia (<1.02 / nl)

          -  protein detected by urine stick test

          -  participation in another clinical trial during the last 2 months or participation in a
             trial with another psoriatic arthritis treatment within 6 months
      