Subcuteous Methotrexate in Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Methotrexate Adverse Reaction; Advantage of Using Subcutaneous Route for Methotrexate
• Interventions: Drug: Tab. Methotrexate 25mg/week; Drug: Inj. Methotrexate 25mg/week

• Registration Number: NCT07094880
• Lead Sponsor: Bangladesh Medical University

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.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Study First Submitted: 2025-05-29
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Tab. Methotrexate 25mg/week	Oral Methotrexate 25 mg will be given weekly
Group B	Inj. Methotrexate 25mg/week	Subcutaneous methotrexate will be given 25mg/week

Primary Outcome Measures

Name	Time	Method
American College of Rheumatology 20	"From enrollment to the end of treatment at 16 weeks"	20% reduction in disease activity