Proof-of-concept Study of Forward Pharma (FP)187 in Patients With Mild/Moderate Psoriatic Arthritis

This is an interventional treatment trial for Psoriatic Arthritis Read More

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