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Trial record 15 of 17 for:    "Connective Tissue Disease" | "Ethanol"

Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis (ACUTE-JIA)

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ClinicalTrials.gov Identifier: NCT01015547
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : October 15, 2015
Sponsor:
Collaborators:
Foundation for Paediatric Research, Finland
Päivikki and Sakari Sohlberg Foundation, Finland
Rheumatism Foundation Hospital
Scandinavian Rheumatology Research Foundation
Paijat-Hame Hospital District
Information provided by (Responsible Party):
Pirjo Tynjala, Helsinki University Central Hospital

Tracking Information
First Submitted Date  ICMJE November 17, 2009
First Posted Date  ICMJE November 18, 2009
Last Update Posted Date October 15, 2015
Study Start Date  ICMJE May 2003
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2009)
ACR Pedi 75 response [ Time Frame: 54 weeks from baseline (0) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01015547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2009)
  • clinically inactive disease [ Time Frame: at 54 weeks ]
  • time spent in inactive disease [ Time Frame: 0 to 54 weeks ]
  • time spent in ACR Pedi 75 [ Time Frame: 0 to 54 weeks ]
  • Other ACR Pedi responses (30, 50, 70, 90, 100) [ Time Frame: 0 to 54 weeks ]
  • drug survival [ Time Frame: 54 weeks ]
  • occurrence of side-effects and adverse events [ Time Frame: 0 to 54 weeks ]
  • cost-benefit ratio in each treatment arm [ Time Frame: 0 to 54 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis
Official Title  ICMJE 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.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Juvenile Idiopathic Arthritis
Intervention  ICMJE
  • 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.
    Other Name: IFX: Remicade, MTX: Trexan or Methotrexate
  • 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.
    Other Name: MTX: Trexan or Methotrexate, SSZ: Salazopyrin, HCQ: Oxiklorin
  • 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.
    Other Name: MTX: Trexan or Methotrexate
Study Arms  ICMJE
  • Experimental: Infliximab plus Methotrexate
    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.
    Intervention: Drug: Infliximab plus methotrexate
  • Experimental: Combination of DMARDs
    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.
    Intervention: Drug: Combination of DMARDs
  • Active Comparator: Methotrexate alone
    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.
    Intervention: Drug: Methotrexate alone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2009)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01015547
Other Study ID Numbers  ICMJE 211864, 318/E0/2002
211864 ( Registry Identifier: www.hus.fi )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pirjo Tynjala, Helsinki University Central Hospital
Study Sponsor  ICMJE Helsinki University Central Hospital
Collaborators  ICMJE
  • Foundation for Paediatric Research, Finland
  • Päivikki and Sakari Sohlberg Foundation, Finland
  • Rheumatism Foundation Hospital
  • Scandinavian Rheumatology Research Foundation
  • Paijat-Hame Hospital District
Investigators  ICMJE
Study Director: Pekka Lahdenne, MD, PhD Hospital for Children and Adolescents in Helsinki University Central Hospital
PRS Account Helsinki University Central Hospital
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP