Comparison of efficacy, safety and Methotrexate poly glutamate levels (active form of methotrexate) between two different oral methotrexate regimens commonly used in treatment of Rheumatoid Arthritis.

Comparison of efficacy and side effect profile of same day s[lit versus twice a week split of oral methotrexate in Rheumatoid Arthritis and comparison of Methotrexate poly glutamate levels in both groups: A randomised controlled study. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093231

Enrollment

Registered

2025-08-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: M05- Rheumatoid arthritis with rheumatoid factor

Interventions

Intervention1: Methotrexate split dose twice weekly: This group will split oral methotrexate on 2 days in a week (Monday and Thursday) and will be followed for 6 months Control Intervention1: Methotre

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients fulfilling ACR/EULAR 2010 criteria of Rheumatoid Arthritis and having moderate disease activity, which is defined by DAS28 more than 3.2 2) Patients who are more than or equal to 18 years old 3) Patients taking oral methotrexate for at least 1 month prior to inclusion in this study 4) Giving consent for participation in the study. 5) Methotrexate dose 15mg/week 6) Not on other conventional synthetic or biological DMARDs except HCQ (400mg/day) or low dose prednisolone (7.5 mg/day)

Exclusion criteria

Exclusion criteria: Patients having significant cytopenias Anemia (Hb less than 6 g/dl), thrombocytopenia (platelet count less than 1 Ã?105/mm3), leukopenia (less than 3000/mm3), ALT/AST more than 80 IU or serum creatinine more than 1.5 mg/dl. 2) Contraindications to methotrexate, which are severe renal, pulmonary and liver disease, pre- existing bone marrow suppression, alcoholic liver disease, pregnancy, breastfeeding or patients planning conception, acute or chronic HBV or HCV infection

Design outcomes

Primary

Measure	Time frame
To assess methotrexate polyglutamate levels and compare its levels between the two groups at Baseline, 3 and 6 months and change in disease severity measures (SDAI, CDAI and DAS28) at 24 weeks compared to baseline and side effect profile (symptomatic & labs) at 24 weeksTimepoint: 1, 3 and 6 months	—

Secondary

Measure	Time frame
1. To assess and compare Mean Glucocorticoid dose and NSAID score at 24 weeks between the two groups 2. To assess and compare Methotrexate intolerance severity score at 24 weeks between the two groups. Timepoint: 1, 3 and 6 months	—

Countries

India

Contacts

Public ContactDr Urmila Dhakad

King George Medical University

drurmiladhakad@gmail.com919696349671

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026