A study of subjects with Psoriatic Arthritis to investigate the effectiveness of adalimumab introduction compared with methotrexate dose escalatio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1. Adult male or female, = 18 years of age at screening
2. PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by C1ASsification of Psoriatic Arthritis (CASPAR) criteria at the Screening visit
3. Not in MDA at the time of screening, defined as not meeting at least 5 of the following 7 criteria:
• Tender joint count (TJC) = 1 out of 68 assessed
• Swollen joint count (SJC) = 1 out of 66 assessed
• PASI = 1 or Body Surface Area (BSA) = 3
• Patient's assessment of pain visual analogue scale (VAS) = 15
• Patient's global assessment of disease activity (PtGA) VAS = 20
• HAQ-DI score = 0.5
• Tender entheseal points = 1 out of 8 assessed
4. Has active arthritis defined as fulfilling both the below criteria at screening and baseline visits:
• = 3 tender joints (out of 68 assessed)
• = 3 swollen joints (out of 66 assessed)
5. Treated with MTX 15 mg ew for PsA defined as:
• Oral or subcutaneous (sc) administration of MTX for at least 4 weeks prior to screening
• Change of the MTX administration route (oral or sc) is permitted in this time period if the administered dose of MTX 15 mg ew is not changed,
• This is the first course of MTX the subject has been receiving for the treatment of PsA,
• Subject has not received a dosage of MTX higher than 15 mg ew prior to the screening visit,
• Subject could have been receiving MTX doses lower than 15 mg ew before reaching the stable dose of MTX 15 mg ew defined above,
• If the subject had been on MTX 15 mg ew for = 12 weeks, temporary MTX discontinuation or dose decrease below 15 mg ew for up to 4 weeks is allowed within the required total period of up to 36 weeks.
6. If subject is receiving concomitant oral corticosteroids, prednisone or equivalent must be = 10 mg/day and the dose must be stable for at least 1week prior to the baseline visit.
7. If subject is receiving nonsteroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase (COX) 2 selective inhibitors, paracetamol (up to the maximum recommended dose in the local country label), or acetaminophen up to 3.0 grams/day, the dose must be stable for at least 1 week prior to the baseline Visit.
8. If subject is receiving other csDMARDs in addition to MTX (i.e., sulfasalazine or leflunomide), the dose must be stable for at least 4 weeks prior to the baseline visit. If csDMARDs are discontinued before study enrollment, the discontinuation must occur at least 4 weeks prior to the baseline Visit.
• Leflunomide should be discontinued at least 4 weeks prior to the baseline visit
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 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1. Has contraindication(s) to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients ( refer to SmPC or prescribing information)
2. Has history of MTX intolerance/toxicity
3. Has medical condition(s) precluding MTX dose increase above 15 mg ew
4. Has had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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