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Comparison of 2 different combination therapy in patients with Rheumatoid Arthritis failing Methotrexate monotherapy

Comparison of Sulfasalazine versus Leflunomide based combination Disease modifying anti rheumatic drug (DMARD) therapy in patients with Rheumatoid Arthritis failing Methotrexate monotherapy : A randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/11/007508
Enrollment
140
Registered
2016-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Rheumatoid arthritis

Interventions

Intervention1: Methotrexate , Sulfasalazine, Hydroxychloroquine: Methotrexate 25mg per week, Sulfasalazine 1 gram twice a day, Hydroxychloroquine 200mg once at night, all in combination for 3 months I

Sponsors

JIPMER Intramural fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.satisfying ACR-EULAR criteria for Rheumatoid arthritis 2.Polyarthritis ( >4 joints) 3.Disease duration of less than 2 years 4.DMARD naïve patients 5.Patients with moderate to severe disease activity (DAS28 >3.2)

Exclusion criteria

Exclusion criteria: 1.End stage disease (deformed fixed joints) 2.Patients with vasculitis, extra-articular features like interstitial lung disease 3.Contraindications to DMARD therapy (Chronic Alcoholism, Chronic liver disease, Evidence of acute/chronic infection, Chronic kidney disease, Patients with leucopenia ( AST/ALT >2Ã? upper normal value and creatinine clearance 4.Pregnant, lactating women, patients (both men and women) of reproductive age group unwilling for contraceptive use who have not completed the family

Design outcomes

Primary

MeasureTime frame
Disease activity (state) DAS28 ESRTimepoint: at baseline, 3 months and 6 months

Secondary

MeasureTime frame
1.Functional ability â?? iHAQ 2.Mean changes over time in: Inflammatory parameters: ESR, hs-CRP 3.Disease activity as per US-7 score and damage by SENS 4.Adverse drug reactionsTimepoint: at baseline , 3 months and 6 months

Countries

India

Contacts

Public ContactDr Vir Singh Negi

Jawaharlal Institute of Postgraduate Medical Education and Research

vsnegi22@yahoo.co.in9443433974

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026