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Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis

NCT01015547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-10-15

No results posted yet for this study

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.

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

DRUG

Infliximab plus methotrexate

IFX given 3-5mg/kg every 6 weeks, oral MTX given 15mg/m2 weekly. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.

DRUG

Combination of DMARDs

IFX given 3-5mg/kg every 6 weeks, oral MTX given 15mg/m2 weekly, SSZ 40mg/kg up to 2000mg daily, HCQ 5mg/kg daily. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.

DRUG

Methotrexate alone

Oral MTX given 15mg/m2 weekly. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.

Sponsors & Collaborators

  • Foundation for Paediatric Research, Finland

    collaborator OTHER

  • Päivikki and Sakari Sohlberg Foundation, Finland

    collaborator OTHER

  • Rheumatism Foundation Hospital

    collaborator OTHER

  • Scandinavian Rheumatology Research Foundation

    collaborator UNKNOWN

  • Paijat-Hame Hospital District

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Pekka Lahdenne, MD, PhD · Hospital for Children and Adolescents in Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2007-11-30
Completion
2013-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015547 on ClinicalTrials.gov