Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis (ACUTE-JIA)
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| ClinicalTrials.gov Identifier: NCT01015547 |
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Recruitment Status :
Completed
First Posted : November 18, 2009
Last Update Posted : October 15, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Juvenile Idiopathic Arthritis | Drug: Infliximab plus methotrexate Drug: Combination of DMARDs Drug: Methotrexate alone | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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. |
| Study Start Date : | May 2003 |
| Actual Primary Completion Date : | November 2007 |
| Actual Study Completion Date : | December 2013 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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 |
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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.
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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 |
- ACR Pedi 75 response [ Time Frame: 54 weeks from baseline (0) ]
- 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 ]
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| Ages Eligible for Study: | 4 Years to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015547
| 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 | |
| Study Director: | Pekka Lahdenne, MD, PhD | Hospital for Children and Adolescents in Helsinki University Central Hospital |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pirjo Tynjala, MD PhD, Helsinki University Central Hospital |
| ClinicalTrials.gov Identifier: | NCT01015547 |
| Other Study ID Numbers: |
211864, 318/E0/2002 211864 ( Registry Identifier: www.hus.fi ) |
| First Posted: | November 18, 2009 Key Record Dates |
| Last Update Posted: | October 15, 2015 |
| Last Verified: | October 2015 |
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juvenile idiopathic arthritis polyarthritis combination therapy |
biologic agents TNF antagonists infliximab |
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Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Sulfasalazine Infliximab Methotrexate Naltrexone Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Gastrointestinal Agents |