Adults diagnosed with Psoriatic Arthritis
Conditions
Interventions
Trade Name: Leflunomide (Arava)
Product Name: Leflunomide
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Methot
Sponsors
St Maartenskliniek
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Adult male or female -Age =18 years -Clinical diagnoses of PsA -Evidence of active disease defined as =2 swollen joints, dactylitis counts as 1 swollen joint. -Subjects that have used cDMARDs and/or bDMARDs before, must have discontinued this treatment for at least 6 months prior to baseline visit. -Subjects who are already taking NSAIDs/COX-2 inhibitors may participate in the study but the dose has to be stable for at least one week prior to first dose of study drug -Oral or injected corticosteroids (intramuscular, intravenous and intra-articular) have to be discontinued 8 weeks prior to first dose of study drug Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: -Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 2 years after the last dose of study drug or up to 11 days after treatment when washout procedure is executed. -Male subject who is considering fathering a child or donating sperm during the study or for approximately 2 years after the last dose of study drug or up to 11 days after treatment when washout procedure is executed. -History of an inadequate response to MTX or LEF (prescribed by a rheumatologist for joint disease). -Current severe infection including, but not limited to: oActive human immunodeficiency virus (HIV) oActive TB -History of an allergic reaction or significant sensitivity to constituents of the study drugs (MTX/LEF) -Current or history of liver insufficiency -History of clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months prior to baseline visit. -Current or recent history of a severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular or neurologic disease. -History of any fibromyalgia or diagnosis of inflammatory rheumatic disease other than PsA. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly. -Abnormal laboratory values within 1 month prior to baseline visit: oSerum alanine transaminase (ALT) > 1.5 × ULN; oEstimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula < 40 mL/min/1.73m2; oTotal white blood cell count (WBC) < 3,000/µL; oPlatelet count < 100,000/µL; oHemoglobin < 10 g/dL (6.3 mmol/L). -Current persistent hypertension requiring start or change of treatment regimen -Malignancy in the past 5 years except for non-melanoma skin cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectiveness of MTX monotherapy with MTX and LEF combination therapy in cDMARD-naïve psoriatic arthritis patients. ;Secondary Objective: Key secondary parameters are: change in skin score, enthesitis score, dactylitis score and swollen/tender joint count. Furthermore, the difference in immunoprofile, treatment failure, and the percentage of (S)AE’s between the two groups will be assessed. ;Primary end point(s): PASDAS score at 16 weeks ;Timepoint(s) of evaluation of this end point: Baseline week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical: -The difference in proportion of patients in LDA state, PASDAS =3.2, in PsA patients between the two arms at week 16 -The difference in proportion of patients in LDA state (DAPSA =14) in PsA patients between the two arms at week 16 -The change of DAPSA score from baseline to 16 weeks -The difference in proportion of patients fulfilling Minimal Disease Activity (MDA) criteria between the two arms at week 16 -The disease impact and quality of life of patients with PsA from pre- to post treatment: •PsA impact of disease (PSAID) at baseline and week 16 •Health assessment questionnaire (HAQ) at baseline and week 16 •Short Form (12) Health Survey (SF12) at baseline and week 16 -The change in skin score (PGA, BSA) between baseline and 16 weeks -The change in swollen joint count between baseline and 16 weeks -The change in tender joint count between baseline and 16 weeks -The change in dactylitis score between baseline and 16 weeks -The change in enthesitis score between baseline and 16 weeks Laboratory: -To assess whether baseline ‘ immunoprofiling’ factors of patients are predictive for treatment response on MTX monotherapy or MTX and LEF combination therapy Safety: -The safety of MTX and LEF combination therapy, by comparing the percentage of adverse events and serious adverse events between the 2 arms ;Timepoint(s) of evaluation of this end point: baseline week 16 | — |
Countries
Netherlands
Contacts
Public ContactMark Wenink
St Maartenskliniek
Outcome results
None listed