Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
Conditions
Interventions
Intervention1: Tablet Methotrexate split-dose once a week: Oral tablets of methotrexate given in split dose (morning/evening) once a week
upto a maximum of 25 mg once a week (i.e. 15 morning - 10 even
Sponsors
PGIMER
Eligibility
Inclusion criteria
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
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. 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 11. HepB/Hep C/HIV +ve OR Active TB or other infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responders (atleast moderate response as per EULAR based on DAS28)Timepoint: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| RBC methotrexate polyglutamate levelsTimepoint: 8, 16 and 24 weeks;EULAR responses (moderate and good), HAQ, ACR20, 50, 70, CDAITimepoint: 16 and 24 weeks;Intolerance scores and laboratory abnormalitiesTimepoint: 16 and 24 weeks | — |
Countries
India
Contacts
Public ContactVarun Dhir
Postgraduate Institute of Medical Education and Research
Outcome results
None listed