EUCTR2016-000191-21-IT进行中（未招募）1 期
A Phase 4 open-label randomized controlled study COmparing the effectiveness of adalimumab iNTROduction and methotrexate dose escaLation in subjects with Psoriatic Arthritis (CONTROL) - CONTRO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 245
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 XML File Identifier: Y4I5F8hzMlIno/ydXqTMKuj7+4o= Page 26/36 (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.
- •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
- •1 week 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), 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), 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
排除标准
- •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
- •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
研究者
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