Subcuteous Methotrexate in Rheumatoid Arthritis

NCT ID: NCT07094880

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2016-06-01

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.

Conditions

Methotrexate Adverse Reaction; Advantage of Using Subcutaneous Route for Methotrexate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Oral Methotrexate 25 mg will be given weekly

Group Type: ACTIVE_COMPARATOR

Tab. Methotrexate 25mg/week

Intervention Type: DRUG

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

Group B

Subcutaneous methotrexate will be given 25mg/week

Group Type: ACTIVE_COMPARATOR

Inj. Methotrexate 25mg/week

Intervention Type: DRUG

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

Interventions

Tab. Methotrexate 25mg/week

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

Intervention Type: DRUG

Inj. Methotrexate 25mg/week

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangladesh Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dr Md. Masudul Hassan

Associated Professor, Bangladesh Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

712/2013

Identifier Type: -

Identifier Source: org_study_id