COMPARING TWO DIFFERENT WAYS OF GIVING ORAL METHOTREXATE (A FIRST LINE DRUG) IN RHEUMATOID ARTHRITIS - TO LOOK AT DIFFERENCE IN BENEFIT AND SIDE EFFECTS WHEN GIVING IT AS A SINGLE DOSE VERSUS AS A SPLIT DOSE (SOME DOSE IN MORNING AND SOME IN EVENING)

Phase 4

Completed

• Conditions: Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

• Registration Number: CTRI/2021/02/031361
• Lead Sponsor: Postgraduate Institute Of Medical Education And Research Chandigarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-03
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 253

Inclusion Criteria

1.Diagnosed as RA based on ACR/EULAR 2010 criteria.

2. RF or CCP positive

3.Age between 18 years to 60 years.

4.Those who give written informed consent to participate in study.

5.Weight equal or more than 40 Kg.

6.Having active disease: At least 4 tender joints and at least 2 swollen joints.

7.Not in Class 4 functional status (i.e. those who are completely dependent).

8.Disease duration less than 5 years (since onset of persistent arthritis).

9.Patients on oral Corticosteroid (less than or equal to 10mg/day), and/or Hydroxychloroquine (up to 400mg/day) allowed, if stable doses for last 1 month prior to enrolment.

Exclusion Criteria

1.Should not be currently on methotrexate and should not have received methotrexate for atleast the last 6 months.

2. Should not currently be on sulfasalazine or leflunomide and should not have received them for at least the last 2 months.

3. Use of biologicals therapies (anti-TNF alpha, Rituximab, Tocilizumab) in the last 6-months.

4.Previous history of Methotrexate intolerance in the past in terms of severe symptomatic side effects like nausea etc.

5. Should not have received JAKinibs (Tofacitinib or Baricitinib) within the last 1 month.

6. Should not have received any Intramuscular or intra-articular depot methylpred/triamcinolone in the last 10 days.

7.Standard exclusion for MTX treatment;

I.Any leucopenia ( < 4000) or thrombocytopenia ( < 1,00,000) done within 1-week of enrolment.

II.Creatinine > 1.3 mg per dl done within 1-week of enrolment.

III.SGOT or SGPT more than 50 IU/L (normal being 40 IU/L) done within 1-week of enrolment.

IV.Hepatitis B or C or HIV positive.

V.Known case of Chronic liver disease.

VI.Either Pregnant or lactating.

VII.Desirous of pregnancy in the next 6 months.

VIII. Known chronic lung disease like bronchiectasis or known case of ILD (with FVC less than 70%).

IX.Active Tuberculosis or other active infections:

Study & Design

• Study Type: Interventional
• Study Design: Not specified