Subcuteous Methotrexate in Rheumatoid Arthritis (SCMTXRA)

Bangladesh Medical University

Status and phase: Completed; Phase 4

Conditions: Methotrexate Adverse Reaction; Advantage of Using Subcutaneous Route for Methotrexate

Treatments: Drug: Tab. Methotrexate 25mg/week; Drug: Inj. Methotrexate 25mg/week

Study type: Interventional

Funder types: Other

Identifiers

NCT07094880

712/2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Group A

Active Comparator group

Description:

Oral Methotrexate 25 mg will be given weekly

Treatment:

Drug: Tab. Methotrexate 25mg/week

Group B

Active Comparator group

Description:

Subcutaneous methotrexate will be given 25mg/week

Treatment:

Drug: Inj. Methotrexate 25mg/week