Comparing methotrexate injection to methotrexate oral tablets (split into two doses) for rheumatoid arthritis treatment

Phase 4

• Conditions: Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement

• Registration Number: CTRI/2023/06/054429
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.1. Meeting ACR/EULAR criteria 2010

2. RF or Anti-CCP positive

3. Given informed Consent

4. Weight at least 40 kg

5.TJC28 of atleast 6 AND SJC 28 of atleast 3

6. Not in Class 4 functional status (fully dependant)

7. Duration of RA of less than or equal to 3 years

Exclusion Criteria

1. Currently on methotrexate /leflunomide/ sulfasalzine or has received them in the last 3 months

2. Taken JAKI in last 1 month

3,. Taken biological agents (TNF inhibitors or rituximab in last 6 months)

4. Pregnant/lactating OR planning pregnancy

5. 5. IM Steroid in last 7 days or Oral Pred >10 mg/d

6. Low blood counts (Hb <7, TLC <4000, Plt <100,000)

7. Raised transaminases (SGOT or SGPT >50 IU/L)

8. Creatinine >1.3mg/dL

9. K/C/O Chronic liver disease

10. K/C/O Chronic lung disease - bronchiectasis/ILD with FVC <70%

11. HepB/Hep C/HIV +ve OR Active TB or other infections

Study & Design

• Study Type: Interventional
• Study Design: Not specified