Mild to moderate psoriatic arthritis MedDRA version: 16.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: FP187
Product Code: FP187
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: DIMETHYL FUMARATE
CAS Number: 624-49-7
Current Sponsor code: FP187
Other descriptive name: DIM
Sponsors
Department of Rheumatology, Skåne University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • male and female of at least 18 years of age; • documented clinical diagnosis of mild to moderate psoriatic arthritis (according to the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 3 months prior to study start; • active psoriatic arthritis at the time of study entrance with at least 2 tender and 2 swollen joints at Visit 1; • 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 (systolic and diastolic blood pressure [upper limit 160/95] pulse rate [between 50 and 100]), electrocardiogram (ECG), and clinical laboratory parameters (hematology, biochemistry and urinalysis)). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance; • if the patients are using methotrexate, they should be on a stable dose not exceeding 20 mg/week for at least 90 days prior to study entrance, and should present no serious toxic side effects attributable to methotrexate; • females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a highly effective (failure rate =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • female patients who are pregnant or breast-feeding or planning to become pregnant during the entire trial period as well as male patients planning pregnancy with their partner during the entire trial period or practice unprotected sexual relationship 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., AIDS/HIV); • known history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to study entrance; • presence of another inflammatory disease, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, 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 malignancies; • presence or history of any malignancy, with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 5 years of study entrance, or cervical carcinoma in situ that has been treated with no evidence of recurrence; • use at any time of any DMARD such as etanercept, adalimumab, golumumab, certolizumab pegol, or infliximab. Patients receiving methotrexate are allowed to participate to the Study if they have receive a stable dose not exceeding 20 mg/week for at least 90 days prior to study entrance, and do not present any serious toxic side effects attributable to methotrexate; • received corticosteroid joint injections within 12 weeks prior to study entrance; • use of any DMF containing products during the past 12 weeks prior to study entrance; • use of any retinoid treatments, other immunosuppressive treatments, cytostatics or drugs with known harmful effects on the kidneys within the last 3 month of study entrance, also if currently kidney functions are normal; • use of cyclosporine, corticosteroids or psoralen + UVA (PUVA) treatment within 4 weeks of Visit 1; • presence of on-going stomach or intestinal problems (e.g., gastritis or peptic ulcer); • liver enzyme results (AST, ALT) > 2 x upper normal limit (ULN) or ?-GT results > 2.5 x ULN; • estimated Creatinine Clearance (Cockcroft-Gault) 750/µL), or lymphocytopenia (count < 1.02 x109/L); • presence of protein detected by urine stick test at Screening and/or Baseline, and confirmed in a subsequent complete urinalysis; • participation in another clinical trial during the last two months preceding study entrance, or participation in a trial with another psoriatic arthritis treatment within 6 months prior to study entrance; • patients who are involved in the organization of the clinical investigation or are in any way dependent on the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of FP187 versus placebo on the proportion of patients with a 20% improvement from Baseline in tender/swollen joint counts according to the American College of Rheumatology criteria (ACR20) based on a 66/68 joint count at Week 24;Secondary Objective: • To explore the efficacy of FP187 versus placebo on the proportion of patients achieving ACR20 at Weeks 8, 12, 28, 36, 40 and 52; • To explore the efficacy of FP187 versus placebo at Weeks 8, 12, 24, 28, 36, 40 and 52 on: - the proportion of patients achieving ACR50; - the proportion of patients achieving ACR70; - the change from Baseline of patients' Body Surface Area (BSA) affected by psoriasis; - the change from Baseline on the Leeds Enthesitis Index (LEI) score; - the change from Baseline in pain Visual Analogue Scale (VAS) score; - the change from Baseline in European Quality of Life-5 Dimensions (EQ-5D) score; - the change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score; - the change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) score; - the change from Baseline on the Health Assessment Questionnaire (HAQ) score.;Primary end point(s): The proportion of patients achieving ACR20 based on a 66/68 joint count at Week 24;Timepoint(s) of evaluation of this end point: Primary endpoint wil be measured after 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints: - The proportion of patients achieving ACR20; - The proportion of patients achieving ACR50; - The proportion of patients achieving ACR70; - The change from Baseline in patients' BSA affected by psoriasis; - The change from Baseline in LEI score; - The change from Baseline in pain VAS score; - The change from Baseline in EQ-5D score; - The change from Baseline in BASDAI score; - The change from Baseline in BASFI score; - The change from Baseline in HAQ score. Safety endpoints: - The occurrence of hematology, standard biochemistry, liver and renal function tests abnormalities up to 28 days after study drug discontinuation; - The occurence of treatment-emergent adverse events up to 28 days after study drug discontinuation.;Timepoint(s) of evaluation of this end point: Secondary endpoints will be measured: - after 8, 12, 28, 36, 40 and 52 weeks of treatment for ACR20; - after 8, 12, 24, 28, 36, 40 and 52 weeks of treatment for other secondary endpoints; | — |
Countries
Sweden
Contacts
Public ContactClinical Trials Information
Department of Rheumatology, Skåne University Hospital
Outcome results
None listed