Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to compare in very early polyarticular juvenile idiopathic arthritis (JIA) the efficacy, safety, and cost-benefit-ratio of three treatment strategies: biologic combination, combination of conventional disease-modifying drugs (DMARDs), and methotrexate alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University Central Hospital
• Collaborators: Foundation for Paediatric Research, Finland; Paijat-Hame Hospital District; Päivikki and Sakari Sohlberg Foundation, Finland; Rheumatism Foundation Hospital; Scandinavian Rheumatology Research Foundation
• Treatments: Antirheumatic Agents; Infliximab; Methotrexate; Naltrexone; Sulfasalazine

Criteria

Inclusion Criteria:

• juvenile idiopathic arthritis

• arthritis lasting for at least 6 weeks but not more than 6 months

• polyarticular disease with at least 5 active joints with at least 3 joints with pain or tenderness and limitation of motion

• no previous treatment with DMARDs

Exclusion Criteria:

• systemic JIA

• any abnormality in the hematopoietic or lymphatic system

• any major concurrent medical condition

• inadequate psychosocial situation

• pregnancy

• a non-abstinent female with reproductive capacity without regular contraceptive use