Subcuteous Methotrexate in Rheumatoid Arthritis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07094880

Acronym

SCMTXRA

Enrollment

Registered

2025-07-30

Start date

2015-06-01

Completion date

2016-06-01

Last updated

2025-07-30

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

Conditions

Advantage of Using Subcutaneous Route for Methotrexate, Methotrexate Adverse Reaction

Keywords

Oral Methotrexate, Subcutaneous Methotrexate, Rheumatoid Arthritis

Brief summary

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

Detailed description

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.

Interventions

DRUGTab. Methotrexate 25mg/week

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

DRUGInj. Methotrexate 25mg/week

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
American College of Rheumatology 20	From enrollment to the end of treatment at 16 weeks	20% reduction in disease activity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026