Methotrexate and leflunomide combination therapy in psoriatic arthritis.
- Conditions
- Adults diagnosed with Psoriatic ArthritisTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-002362-39-NL
- Lead Sponsor
- St Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 78
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>week 16
- Secondary Outcome Measures
Name Time Method