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comparison between methotrexate versus methotrexate plus leflunomide treatment in arthritis associated with psoriasis

Comparison of Methotrexate Monotherapy versus Methotrexate and Leflunomide Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in patients with Psoriatic Arthritis: A Randomized Control Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008888
Enrollment
242
Registered
2017-06-21
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: L405- Arthropathic psoriasis Health Condition 2: M138- Other specified arthritis Health Condition 3: null- Psoriatic arthritis

Interventions

Intervention1: group 1: Methotrexate, starting dose 10 mg/week orally for 2 weeks , if minimum disease activity is not achieved in 2 weeks dose will be increased 5 mg every 2 weeks until minimum disea

Sponsors

JIPMER intramural fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients satisfying CASPAR criteria for Psoriatic Arthritis 2. At least 3 peripheral joints with active arthritis 3. DMARD naïve patients

Exclusion criteria

Exclusion criteria: 1. End stage disease (deformed fixed joints) 2. Contraindications to DMARD therapy (Chronic alcoholism, chronic liver disease, evidence of acute/chronic infection, chronic kidney disease, patients with leucopenia ( 2Ã? upper normal value and creatinine clearance 3. Pregnant or lactating women; patients (both men and women) of reproductive age group unwilling for contraceptive use who have not completed the family 4. Psoriatic arthritis with only axial involvement

Design outcomes

Primary

MeasureTime frame
Adverse drug reactions and Response to treatment - by PsARC criteria Timepoint: PsARC criteria at 24 weeks of starting treatment Adverse reaction during the study

Secondary

MeasureTime frame
a. Functional ability â?? iHAQ b. ACR 20 and ACR 50 response criteria c. PASI score d. DAPSA score e. Percentage of patients attaining MDA in each group f. Changes in serum interleukin (IL-1α), interleukin 1 β (IL-1β) , interleukin-6(IL-6) and tumor necrosis factor α(TNF-α) Timepoint: base line and 6 months

Countries

India

Contacts

Public ContactDr Shanoj K C

Jawaharlal Institute of Postgraduate Medical Education and Research

vsnegi22@yahoo.co.in8940482248

Outcome results

None listed

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