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Completed

NCT Number: NCT07094880

Subcuteous Methotrexate in Rheumatoid Arthritis

Methotrexate use is important for the treatment of Rheumatoid arthritis. Some patients can not tolerate oral methotrexate. So subcutaneous may help to overcome it.

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Key information

Conditions

Methotrexate Adverse Reaction Advantage of Using Subcutaneous Route for Methotrexate Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Objective: To see the efficacy and safety of subcutaneous (SC) methotrexate (MTX) in patients suffering from active rheumatoid arthritis (RA). Methods: This was an open labeled randomized clinical trial. Total 90 patients were enrolled from out-patient and in-patients department of medicine (Rheumatology wing) Bangabandhu Sheikh Mujib Medical University. This study was done in two phases. In phase 1, after enrollment 10 mg MTX was given to all patients. After 4 weeks, the dose of MTX was increased by 5 mg. All patients were followed up at 8 weeks from enrollment for outcome measures and tolerability. In phase 2, patients who are intolerant to oral MTX will received 20 mg MTX subcutaneously (n=40). After 8 weeks the dose of MTX was increased by 5 mg. So, 25 mg MTX was given and after another 8 weeks final follow up was given both for clinical and laboratory outcome measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must fulfill the ACR 1987 revised criteria
  • The disease should be active
  • Age 18-70 years

Exclusion criteria

  • Presence of other rheumatologic disorder
  • Pregnancy, lactating mother and women with child bearing potential failing to confirm adequate contraception

Treatment and study plan

Tab. Methotrexate 25mg/week

Drug

Tab. Methotrexate will be given orally in one arm at a dose of 25 mg/week

Inj. Methotrexate 25mg/week

Drug

Inj. Methotrexate 25 mg/week will be given subcutaneously in another arm

Primary outcomes

  1. American College of Rheumatology 20

    Time frame: "From enrollment to the end of treatment at 16 weeks"

    20% reduction in disease activity

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Official study title

Study on the Use of Subcuteous Use of Methotrexate in Patients With Active Rheumatoid Arthritis

Acronym: SCMTXRA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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