NCT07094880

Subcuteous Methotrexate in Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Bangladesh Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Methotrexate Adverse Reaction
• Advantage of Using Subcutaneous Route for Methotrexate

Interventions

Type	Name	Description
DRUG	Tab. Methotrexate 25mg/week	Tab. Methotrexate will be given orally in one arm at a dose of 25 mg/week
DRUG	Inj. Methotrexate 25mg/week	Inj. Methotrexate 25 mg/week will be given subcutaneously in another arm

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2025-07-30
• Last updated: 2025-07-30