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Juvenile Idiopathic ArthritisPhase 3ACUTE-JIANCT01015547

Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis

A Phase 3 study testing Infliximab plus methotrexate, Combination of DMARDs and Methotrexate alone in people with Juvenile Idiopathic Arthritis, run by Helsinki University Central Hospital at 6 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 15 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
Infliximab plus methotrexate, Combination of DMARDs and Methotrexate alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
6 sitesFinland
Study dates
May 2003to Dec 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Finland6 sites

  • Rheumatism Foundation Hospital

    Heinola

  • Hospital for Children and Adolescents

    Helsinki

  • Kuopio University Hospital

    Kuopio

  • Oulu University Central Hospital

    Oulu

  • Tampere University Hospital

    Tampere

  • Turku University Hospital

    Turku

Other trials in Finland

About this study

Official title: Comparison of Anti-TNF Therapy Plus Methotrexate, Combination Therapy of DMARDs, and Methotrexate Alone in Very Early Polyarticular Juvenile Idiopathic Arthritis. A National Randomized Multicenter Clinical Trial.

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.

Read the detailed description

DMARD-naive polyarticular JIA patients with an early disease (onset less than 6 months) are randomized into one of three treatment strategies: (1) biological combination, i.e., anti-TNF therapy with infliximab plus methotrexate; (2) Combination of DMARDs with methotrexate, sulfasalazine, plus hydroxychloroquine; and (3) Methotrexate alone.

The efficacy is evaluated by American College of Rheumatology Pediatric (ACR Pedi) criteria based on 6 core set variables (CSVs): 1. no of active joints; 2. no. of joints with pain or tenderness and limitation of motion; 3. ESR (mm/hr); 4. the Childhood Health Assessment Questionnaire (CHAQ); 5. Physician's Visual Analogue Scale (VAS); 6. Patient/Parent VAS. To fulfill ACR Pedi 75 criteria, 3/6 CSVs have to improve 75% and not more than 1/6 CSV worsen more than 30%. All direct and indirect costs are documented.

The first phase of the study is open-label clinical trial lasting for 54 weeks. In the second phase of the study the patients are followed up to 5 years, and the long-term outcome of early aggressive therapy is analyzed. Serum, urine, and saliva samples are collected at 3 and 5 years for translational research.

Being tested
Infliximab plus methotrexate, Combination of DMARDs, Methotrexate alone
Keywords
juvenile idiopathic arthritis, polyarthritis, combination therapy, biologic agents, TNF antagonists, infliximab
Medical subject headings
Arthritis, Juvenile, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infliximab plus methotrexateDrug

    Also called IFX: Remicade, MTX: Trexan or 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.

  • Combination of DMARDsDrug

    Also called MTX: Trexan or Methotrexate, SSZ: Salazopyrin, HCQ: Oxiklorin

    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.

  • Methotrexate aloneDrug

    Also called MTX: Trexan or Methotrexate

    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.

Study groups in NCT01015547
Study groupRoleWhat they receive
Infliximab plus MethotrexateExperimentalinfliximab 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.
Receives: Drug: Infliximab plus methotrexate
Combination of DMARDsExperimentalmethotrexate 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.
Receives: Drug: Combination of DMARDs
Methotrexate aloneActive comparatorConventional 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.
Receives: Drug: Methotrexate alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ACR Pedi 75 response

    Measured: 54 weeks from baseline (0)

Secondary outcomes (7)

  1. clinically inactive disease

    Measured: at 54 weeks

  2. time spent in inactive disease

    Measured: 0 to 54 weeks

  3. time spent in ACR Pedi 75

    Measured: 0 to 54 weeks

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

    Measured: 0 to 54 weeks

  5. drug survival

    Measured: 54 weeks

  6. occurrence of side-effects and adverse events

    Measured: 0 to 54 weeks

  7. cost-benefit ratio in each treatment arm

    Measured: 0 to 54 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2009 (estimated)
  2. Study startMay 2003
  3. Primary completionNov 2007
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01015547
Sponsor's protocol ID
211864, 318/E0/2002
Other IDs
211864
Acronym
ACUTE-JIA
Status last verified
Oct 2015
First submitted
17 Nov 2009
Last updated
15 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12594111

  • 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.

    PubMed 21623000

  • 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.

    PubMed 36384562

  • 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.

    PubMed 31842940

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infliximab plus methotrexate, Combination of DMARDs and Methotrexate alone in people with Juvenile Idiopathic Arthritis, run by Helsinki University Central Hospital at 6 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR Pedi 75 response (time frame: 54 weeks from baseline (0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01015547, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.

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