A Randomized, Double Blind, Placebo-controlled Proof-of-concept Study of FP187 in Patients With Mild to Moderate Psoriatic Arthritis
Overview
- Phase
- Phase 2
- Intervention
- FP187
- Conditions
- Psoriatic Arthritis
- Sponsor
- Skane University Hospital
- Locations
- 1
- Primary Endpoint
- American Congress of Rheumatology (ACR)20
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to investigate, whether FP187 is effective in the treatment of mild to moderate psoriatic arthritis.
Detailed Description
The study is randomised, double blind, placebo-controlled proof-of-concept trial to investigate the efficacy and safety of FP187 compared to placebo over 24 weeks of treatment in patients with mild to moderate psoriatic arthritis (PsA). The daily dose levels in the FP187 arm will be 500 mg. After completion of the double blind treatment of 24 weeks, all patients irrespective of their treatment arm will be switched to an additional 24 week open-label treatment phase with 500 mg / day FP187. Patient who do not complete the 24 week double blind part of the study as scheduled will not be eligible for participation in the open-label part.
Investigators
Elke Theander
senior consultant Rheumatology, associate professor, PhD
Skane University Hospital
Eligibility Criteria
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
Arms & Interventions
Experimental FP187
Treatment with a daily dose of 500mg FP187 (twice daily). Other names: Dimethyl fumarate
Intervention: FP187
Placebo Comparator
Patients will receive the same number of tablets as patients randomized to FP187 arm in order to maintain the blind. The colour and shape of the FP187 and placebo tablets will be the same so that no visible difference is detectable
Intervention: Placebo
Outcomes
Primary Outcomes
American Congress of Rheumatology (ACR)20
Time Frame: Week 24
Proportion of patients with a 20% improvement from baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR) based on a 66/68 joint count.
Secondary Outcomes
- BSA(Weeks 8, 12, 24, 28, 36, 40, 52)
- LEI(Weeks 8, 12, 24, 28, 36, 40, 52)
- ACR 50(Weeks 8, 12, 24, 28, 36, 40, 52)
- ACR 70(Weeks 8, 12, 24, 28, 36, 40, 52)
- Pain(Weeks 8, 12, 24, 28, 36, 40, 52)
- EQ-5D(Weeks 8, 12, 24, 28, 36, 40, 52)
- BASFI(Weeks 8, 12, 24, 28, 36, 40, 52)
- HAQ(Weeks 8, 12, 24, 28, 36, 40, 52)
- ACR 20(Weeks 8, 12, 28, 36, 40, 52)
- BASDAI(Weeks 8, 12, 24, 28, 36, 40, 52)