NCT01015547

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2003

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

4.5 years

First QC Date

November 17, 2009

Last Update Submit

October 13, 2015

Conditions

Juvenile Idiopathic Arthritis

Keywords

juvenile idiopathic arthritispolyarthritiscombination therapybiologic agentsTNF antagonistsinfliximab

Outcome Measures

Primary Outcomes (1)

  • ACR Pedi 75 response

    54 weeks from baseline (0)

Secondary Outcomes (7)

  • clinically inactive disease

    at 54 weeks

  • time spent in inactive disease

    0 to 54 weeks

  • time spent in ACR Pedi 75

    0 to 54 weeks

  • Other ACR Pedi responses (30, 50, 70, 90, 100)

    0 to 54 weeks

  • drug survival

    54 weeks

  • +2 more secondary outcomes

Study Arms (3)

Infliximab plus Methotrexate

EXPERIMENTAL

infliximab 3-5 mg/kg every 6 weeks, plus methotrexate 15 mg/m2 weekly given orally (dose escalation if ACR Pedi less than 75). no oral prednisolone. intra-articular steroids allowed.

Drug: Infliximab plus methotrexate

Combination of DMARDs

EXPERIMENTAL

methotrexate 15mg/m2 weekly given orally (dose escalation and parenteral injection if ACR Pedi less than 75), plus standard doses of sulfasalazine and hydroxychloroquine. no oral prednisolone. intra-articular steroids allowed.

Drug: Combination of DMARDs

Methotrexate alone

ACTIVE COMPARATOR

Conventional drug therapy: methotrexate 15mg/m2 weekly given orally (dose escalation and parenteral injection if ACR Pedi less than 75). no oral prednisolone. intra-articular steroids allowed.

Drug: Methotrexate alone

Interventions

Infliximab plus methotrexateDRUG

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.

Also known as: IFX: Remicade, MTX: Trexan or Methotrexate
Infliximab plus Methotrexate
Combination of DMARDsDRUG

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.

Also known as: MTX: Trexan or Methotrexate, SSZ: Salazopyrin, HCQ: Oxiklorin
Combination of DMARDs
Methotrexate aloneDRUG

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.

Also known as: MTX: Trexan or Methotrexate
Methotrexate alone

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Rheumatism Foundation Hospital

Heinola, Finland

Location

Hospital for Children and Adolescents

Helsinki, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Oulu University Central Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (4)

  • Lahdenne P, Vahasalo P, Honkanen V. Infliximab or etanercept in the treatment of children with refractory juvenile idiopathic arthritis: an open label study. Ann Rheum Dis. 2003 Mar;62(3):245-7. doi: 10.1136/ard.62.3.245.

    PMID: 12594111BACKGROUND

  • Tynjala P, Vahasalo P, Tarkiainen M, Kroger L, Aalto K, Malin M, Putto-Laurila A, Honkanen V, Lahdenne P. Aggressive combination drug therapy in very early polyarticular juvenile idiopathic arthritis (ACUTE-JIA): a multicentre randomised open-label clinical trial. Ann Rheum Dis. 2011 Sep;70(9):1605-12. doi: 10.1136/ard.2010.143347. Epub 2011 May 28.

    PMID: 21623000RESULT

  • Tarkiainen M, Tynjala P, Vahasalo P, Aalto K, Kroger L, Rebane K, Lahdenne P, Martikainen J. Economic evaluation of infliximab, synthetic triple therapy and methotrexate in the treatment of newly diagnosed juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2022 Nov 16;20(1):97. doi: 10.1186/s12969-022-00748-w.

    PMID: 36384562DERIVED

  • Tarkiainen M, Tynjala P, Vahasalo P, Kroger L, Aalto K, Lahdenne P. Health-related quality of life during early aggressive treatment in patients with polyarticular juvenile idiopathic arthritis: results from randomized controlled trial. Pediatr Rheumatol Online J. 2019 Dec 16;17(1):80. doi: 10.1186/s12969-019-0370-1.

    PMID: 31842940DERIVED

MeSH Terms

Conditions

Arthritis, JuvenileArthritis

Interventions

InfliximabMethotrexate

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pekka Lahdenne, MD, PhD

    Hospital for Children and Adolescents in Helsinki University Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

May 1, 2003

Primary Completion

November 1, 2007

Study Completion

December 1, 2013

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

FI(6)