NCT01659242

Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging Study

Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis Patients With Active Disease Despite Methotrexate: an Ultrasound and Magnetic Resonance Imaging Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In rheumatoid arthritis patients with active disease despite optimal treatment with methotrexate, the main objective of this pilot study is to use advance imaging tools such as magnetic resonance imaging and ultrasound to evaluate which treatment option is more efficacious: initiating methotrexate/sulfasalazine combination therapy, or switching to leflunomide monotherapy

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Methotrexate plus sulfasalazine	ARM 1(Methotrexate(MTX) plus Sulfasalazine(SSZ)) SSZ:Oral form, 2g/day, with escalation regime starting from 1g/day for the first week and increase to 1.5g/day in the next week and increasing to 2g/day by the third week. Total treatment period is 16 weeks. After reaching 2g/day, if patients conditions warrants (and no contraindication), SSZ may be increased at 0.5g per clinic visit) up to a maximum of 3g/day. MTX:Kept at the highest optimal dose.
DRUG	Leflunomide	ARM 2:Leflunomide(LEF) LEF: Oral form, 20mg every other day for first 2 weeks then increasing to 20mg per day by the third week. Total treatment period is 16 weeks. Methotrexate:Off

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-12-01
• First posted: 2012-08-07
• Last updated: 2014-12-02

Locations

1 site across 1 country: Singapore