Status:
ACTIVE_NOT_RECRUITING
Methotrexate in Patients with Early Rheumatoid Arthritis
Lead Sponsor:
Region Västerbotten
Collaborating Sponsors:
Region Gävleborg
Umeå University
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-95 years
Phase:
PHASE4
Brief Summary
Rheumatoid arthritis (RA) is a chronic inflammatory disease primarily affecting the small joints of hands and feet, but may also present with systemic, extraarticular features. The Swedish Rheumatolog...
Detailed Description
Rheumatoid arthritis (RA) is a chronic inflammatory disease primarily affecting the small joints of hands and feet, but may also present with systemic, extraarticular features. Pain and stiffness indu...
Eligibility Criteria
Inclusion
- 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:
- Comply to use of highly effective contraception methods during the course of the trial.
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT05353829
Start Date
April 28 2022
End Date
December 31 2026
Last Update
January 14 2025
Active Locations (13)
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1
Region Sörmland
Eskilstuna, Sweden
2
Region Dalarna
Falun, Sweden
3
Region Gävleborg
Gävle, Sweden
4
Region Norrbotten
Luleå, Sweden