Efficacy, tolerability and preferences of peroral or subcutaneous methotrexate in patients with early rheumatoid arthritis – a randomized register based multicenter study

Västerbotten county0 个研究点目标入组 212 人开始时间: 2021年1月11日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•To be included in the study, subjects must meet the following criteria:
•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
•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 170
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 42

•Subjects must not be included in the study if any of the following criteria are met:
•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

发起方

Västerbotten county