Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis (ACUTE-JIA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Helsinki University Central Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Helsinki University Central Hospital
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:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01015547
First received: November 17, 2009
Last updated: December 12, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Juvenile Idiopathic Arthritis |
Drug: Infliximab plus methotrexate Drug: Combination of DMARDs Drug: Methotrexate alone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
juvenile idiopathic arthritis
MedlinePlus related topics:
Juvenile Rheumatoid Arthritis
Drug Information available for:
Methotrexate
Methotrexate sodium
Naltrexone
Naltrexone hydrochloride
Infliximab
U.S. FDA Resources
Further study details as provided by Helsinki University Central Hospital:
Primary Outcome Measures:
- ACR Pedi 75 response [ Time Frame: 54 weeks from baseline (0) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- clinically inactive disease [ Time Frame: at 54 weeks ] [ Designated as safety issue: No ]
- time spent in inactive disease [ Time Frame: 0 to 54 weeks ] [ Designated as safety issue: No ]
- time spent in ACR Pedi 75 [ Time Frame: 0 to 54 weeks ] [ Designated as safety issue: No ]
- Other ACR Pedi responses (30, 50, 70, 90, 100) [ Time Frame: 0 to 54 weeks ] [ Designated as safety issue: No ]
- drug survival [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
- occurrence of side-effects and adverse events [ Time Frame: 0 to 54 weeks ] [ Designated as safety issue: Yes ]
- cost-benefit ratio in each treatment arm [ Time Frame: 0 to 54 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
|
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.
|
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
|
|
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.
|
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
|
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.
Eligibility| Ages Eligible for Study: | 4 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015547
Locations
| Finland | |
| Rheumatism Foundation Hospital | |
| Heinola, Finland | |
| Hospital for Children and Adolescents | |
| Helsinki, Finland | |
| Kuopio University Hospital | |
| Kuopio, Finland | |
| Oulu University Central Hospital | |
| Oulu, Finland | |
| Tampere University Hospital | |
| Tampere, Finland | |
| Turku University Hospital | |
| Turku, Finland | |
Sponsors and Collaborators
Helsinki University Central Hospital
Foundation for Paediatric Research, Finland
Päivikki and Sakari Sohlberg Foundation, Finland
Rheumatism Foundation Hospital
Scandinavian Rheumatology Research Foundation
Paijat-Hame Hospital District
Investigators
| Study Director: | Pekka Lahdenne, MD, PhD | Hospital for Children and Adolescents in Helsinki University Central Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Pirjo Tynjälä, MD, PhD, Hospital for Children and Adolescents and Hospital District of Helsinki and Uusimaa |
| ClinicalTrials.gov Identifier: | NCT01015547 History of Changes |
| Other Study ID Numbers: | 211864, 318/E0/2002, 211864 |
| Study First Received: | November 17, 2009 |
| Last Updated: | December 12, 2009 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by Helsinki University Central Hospital:
|
juvenile idiopathic arthritis polyarthritis combination therapy |
biologic agents TNF antagonists infliximab |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Juvenile Rheumatoid Joint Diseases Musculoskeletal Diseases Arthritis, Rheumatoid Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Infliximab Antirheumatic Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Nucleic Acid Synthesis Inhibitors Gastrointestinal Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 21, 2013