2024-512453-25-00招募中4 期
Efficacy, tolerability and preferences of per oral or subcutaneous methotrexate in patients with early rheumatoid arthritis – a randomised register based multicentre study
Region Vaesterbotten9 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2024年7月3日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 212
- 试验地点
- 9
- 主要终点
- DAS28
研究概览
简要总结
Difference in DAS28 over 12 months of follow-up between patients with newly diagnosed RA randomised to either oral or subcutaneous methotrexat.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •The subject has given written consent to participate in the study
- •Diagnosis of rheumatoid arthritis by rheumatologist fulfilling 2010 Rheumatoid Arthritis Classification Criteria
- •Indication of methotrexate
- •18-95 years of age
- •Women of Childbearing Capacity (WOCBC) must: a) Comply to use of highly effective contraception methods during the course of the trial. b) Have a negative pregnancy test.
- •Male patients included in the study that have fertile female partners must use adequate contraception within their relationship during the same period of time
排除标准
- •Contraindications for methotrexate
- •Previous treatment with any DMARD within the last five years
- •Known or suspected allergies against methotrexate or any other substance in the given medication
- •Anamnestic information on pregnancy, breastfeeding, or planned pregnancy
- •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation or inability to answer questionnaire in written Swedish
- •Treatment or disease which, according to the investigator, can affect treatment or study results.
- •Fear of needles leading to not being able to use subcutaneous injections
- •For the study in gut microbiota: Use of antibiotics or probiotics within the last 3 months
结局指标
主要结局
DAS28
DAS28
次要结局
- Number of swollen joints
- Number of tender joints
- HAQ
- VAS pain
- VAS general health
- VAS fatigue
- Doctor's global assessment
- Number of individuals remaining on the designated drug (drug retention) including number of individuals prescribed biologic treatment
- Number of patient´s contact with any health care giver
- All other medications, including corticosteroids, other csDMARDs, biologics, intraarticular injections as well as change in dosage or administration route of methotrexate
- ESR
- CRP
- Number of AE
- Patients preferences
- EQ5D
- Gutmicrobiota
- Questions on diet and alcohol consumption
研究者
Anna Södergren
Scientific
Region Vaesterbotten
研究点 (9)
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