Is there a difference in efficacy, tolerability and preferences between methotrexate given as tablets or given as injections in patients with early rheumatoid arthritis – a randomized register based multicenter study

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000462-41-SE

Enrollment

212

Registered

2021-01-11

Start date

2021-02-09

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Pharmaceutical Form: INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 2.5-10 Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to study difference in DAS28 over 12 months of follow up in patients with newly diagnosed RA randomized to oral or subcutaneous methotrexate;Secondary Objective: The secondary objective of this study is to study the treatment-efficacy in other aspects, drug retention after 24 months as well as number of adverse events Is there a change in gut microbiota driven by per oral methotrexate that is different from the change driven by subcutaneous methotrexate What are the trade-offs newly diagnosed patients with RA willing to make with regard to treatment with methotrexate? What are the maximum acceptable levels of risks for newly diagnosed patients with RA? Is there a difference in health-related quality of life in patients treated with per oral methotrexate compared to patients treated with subcutaneous methotrexate during the first two years of treatment? Is it possible to further model a difference in health-related quality of life during further follow up of these individuals?;Primary end point(s): Primary variable: At inclusion and at all timepoints of follow up register DAS28, calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * [general health];Timepoint(s) of evaluation of this end point: At each visit (after 0, 3, 6, 12 and 24 months)	—

Measure

Time frame

Main Objective: The primary objective of this study is to study difference in DAS28 over 12 months of follow up in patients with newly diagnosed RA randomized to oral or subcutaneous methotrexate;Secondary Objective: The secondary objective of this study is to study the treatment-efficacy in other aspects, drug retention after 24 months as well as number of adverse events Is there a change in gut microbiota driven by per oral methotrexate that is different from the change driven by subcutaneous methotrexate What are the trade-offs newly diagnosed patients with RA willing to make with regard to treatment with methotrexate? What are the maximum acceptable levels of risks for newly diagnosed patients with RA? Is there a difference in health-related quality of life in patients treated with per oral methotrexate compared to patients treated with subcutaneous methotrexate during the first two years of treatment? Is it possible to further model a difference in health-related quality of life during further follow up of these individuals?;Primary end point(s): Primary variable: At inclusion and at all timepoints of follow up register DAS28, calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * [general health];Timepoint(s) of evaluation of this end point: At each visit (after 0, 3, 6, 12 and 24 months)

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Secondary

Measure	Time frame
Secondary end point(s): 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 Hemoglobin White blood cell count Thrombocytes Liver function Kidney function Number of AE Patients preferences EQ5D Gutmicrobiota Questions on diet and alcohol consumption;Timepoint(s) of evaluation of this end point: At each visit (after 0, 3, 6, 12 and 24 months)	—

Measure

Time frame

Secondary end point(s): 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 Hemoglobin White blood cell count Thrombocytes Liver function Kidney function Number of AE Patients preferences EQ5D Gutmicrobiota Questions on diet and alcohol consumption;Timepoint(s) of evaluation of this end point: At each visit (after 0, 3, 6, 12 and 24 months)

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Countries

Sweden

Contacts

Public ContactSponsor

Anna Södergren

anna.sodergren@umu.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026