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Efficacy, tolerability and preferences of per oral or subcutaneous methotrexate in patients with early rheumatoid arthritis – a randomised register based multicentre study
EU CTIS ID: 2024-512453-25-00
What this study is testing
Difference in DAS28 over 12 months of follow-up between patients with newly diagnosed RA randomised to either oral or subcutaneous methotrexat.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.