EUCTR2012-000222-21-DE进行中（未招募）不适用
An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis - Preference MTX pre-filled syringe vs pre-filled pen in RA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Written informed consent
- •- Age between 18 and 75 years
- •- Diagnosis of definite rheumatoid arthritis according to the ACR Criteria (1987) or ACR/EULAR (2010)
- •- Patient requiring initiation or intensification of MTX therapy due to remaining RA activity (DAS28 > 2.6)
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Prior or other current subcutaneous treatment with self-injection
- •- Prior or concomitant treatment with biologics
- •- Renal insufficiency (creatinine > 1.5 ULN)
- •- History or acute signs of hepatic insufficiency (ALT or AST > 2 x ULN, bilirubin > 5 mg/dl)
- •- Impaired haematopoiesis (platelets < 100 x 109/L, leukocytes < 3,5 x 109/L ), significant anaemia (haemoglobin < 10 g/dl)
- •- Known severe, acute or chronic infection like hepatitis B or C, tuberculosis or HIV
- •- Active ulcer of oral cavity or ulcer of gastrointestinal tract
- •- History or diagnosis of a dermatological disease in the area of the injection-site which could interfere with a proper assessment
- •- Malignant disease (except treated basal carcinoma and complete remission > 5 year for all other malignancies)
- •- Known alcohol or drug addiction
- •- Patients with a known history of any previous generalised allergic reactions or serious adverse reactions to the study medication or other components of the injection solution
- •- Women with child-bearing potential who do not use a highly effective method of contraception (pearl index < 1%) such as combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide during the study and at least 6 months thereafter.
- •- Men who have a partner with child-bearing potential and do not use a condom or a cervical cap / diaphragm with spermicide during the study and at least 6 months thereafter.
- •- Pregnant or breast feeding women
- •- Patients simultaneously participating or having participated in another clinical trial in the 8 weeks before study start
- •- Patients with any form of psychiatric disorder or other conditions which, in the opinion of the investigator, might invalidate or complicate communication with the patient
- •- Insufficient knowledge in German to understand perfectly the questionnaires
- •- Concurrent vaccination with live vaccines
研究者
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