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Children with arthritis: monotherapy or polytherapy?


- candidate number24431
- NTR NumberNTR5887
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jun-2016
- Secondary IDsABR NL 5317005815
- Public TitleChildren with arthritis: monotherapy or polytherapy?
- Scientific TitleChildren with arthritis: monotherapy or polytherapy?
- ACRONYMCHAMP
- hypothesisCombinationtherapy with methotrexate, sulfasalazine en hydroxychloroquine will result in more patients with inactive disease and therefore less patients that need an TNF-inhibitor after 6 months of treatment than treatment with methotrexate alone in children with recently diagnosed juvenile idiopathic arthritis.
- Healt Condition(s) or Problem(s) studiedJuvenile idiopathic arthritis (JIA)
- Inclusion criteria- Patients with persistent or extended oligoarticular JIA, RF-negative polyarticular JIA, RF- positive polyiarticular JIA, psoriatic JIA, enthesitis-related JIA or undifferentiated JIA according to ILAR Classification criteria
- Active synovitis
- Requiring DMARD therapy according to the treating pediatric rheumatologist. In case of persistent oligoarticular JIA this means patients with poor clinical prognostic factors, for example according to Beukelman7
- Age between 2-16 years
- Treated in one of the Dutch paediatric rheumatology centres
- A maximum of 18 months of symptoms
- Exclusion criteria- Systemic onset Juvenile Idiopathic Arthritis
- Patients with oligoarticular JIA with mono-arthritis of a knee
- Previous treatment with DMARDs (including study medication) or a biological
- Any concurrent illness that would constitute an increased risk for side effects of medication, is associated with an increased risk for severe infections or in the opinion of the treating physician is a contraindication for treatment with any of the initial therapies or participation in the trial as such.
- Current or prior history of blood dyscrasias. Abnormal safety baseline blood test e.g. haemoglobin °‹ 5 mmol/l; haematocrit °‹ 27%; platelet count °‹ 125 x 109 /L; white blood cell count °‹ 3.5x 109 /L; serum creatinine °› 2 times the laboratory°Įs upper limit of normal; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) °› 2 times the laboratory°Įs upper limit of normal.
- Pregnancy
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jun-2016
- planned closingdate1-sep-2020
- Target number of participants130
- InterventionsArm 1: methotrexate monotherapy
Arma 2: combination therapy with methotrexate, sulfasalazine en hydroxychloroquine
- Primary outcomeThe number of patients with inactive disease after 6 months of treatment
- Secondary outcome- Side effects and tolerability of treatment in both treatment arms
- Number of patients that are treated with a TNF inhibitor after 12 months of treatment in both arms
- The number of patients that need to switch to subcutaneous MTX after 3 months of treatment in both treatment arms
- ACR Pedi scores (30, 50, 70, 90) and clinical JADAS scores in both treatment groups at 3, 6, 9, and 12 months and the number of patients with inactive disease at 3, 9 and 12 months of treatment
- Functional ability and quality of life in both treatment arms
- Cost-effectiveness data concerning the first year of DMARD therapy in both groups
- Possible predictors of response, such as serologic and genetic markers
- Timepointsbaseline, 3,6,9 and 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Leontien van der Aa
- CONTACT for SCIENTIFIC QUERIES Leontien van der Aa
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryRationale: Initial disease modifying antirheumatic drug (DMARD) therapy with methotrexate in the treatment of juvenile idiopathic arthritis (JIA) has a low efficacy. For this reason, it has been proposed that TNF-inhibitors may be used as a first-line treatment. The response to TNF inhibitors is often more rapid, but the treatment has the downside of parenteral use and high costs. In adults with rheumatoid arthritis, polytherapy with a combination of DMARDs has been proven to be very effective. We therefore propose that polytherapy with methotrexate, sulfasalazine and hydroxychloroquine could be beneficial for children with juvenile idiopathic arthritis who require DMARD therapy.

Primary objectives: To study whether polytherapy (methotrexate, sulfasalazine and hydroxychloroquine) results in more patients with inactive disease and therefore less patients that need treatment with a TNF inhibitor after 6 months of treatment compared to primary MTX monotherapy in children with newly diagnosed JIA.

Secondary objectives: - To compare side effects and tolerability of treatment in both treatment arms
- To compare the number of patients that are treated with a TNF inhibitor after 12 months of treatment in both arms
- To compare the number of patients that need to switch to subcutaneous MTX after 3 months of treatment in both treatment arms
- To compare ACR Pedi scores (30, 50, 70, 90) and JADAS scores in both treatment groups at 3, 6, 9, and 12 months and the number of patients with inactive disease at 3, 9 and 12 months of treatment
- To compare functional ability and quality of life in both treatment arms
- To provide cost-effectiveness data concerning the first year of DMARD therapy in both groups

Study design: A multicenter, single-blinded, randomized, treat to target, one-year follow-up clinical trial in patients with recent onset JIA.

Study population: Children (2-16 years old) with JIA and active disease.

Intervention: Patients are randomly assigned to one of two treatment strategies: monotherapy with methotrexate (in combination with prednisolone bridging) or polytherapy with methotrexate, sulfasalazine and hydroxychloroquine (in combination with prednisolone bridging). When improvement is not sufficient after 3 months of treatment (according to JADAS10 cut-off values), methotrexate will be switched to subcutaneous administration in either strategy. When at 6 months inactive disease (according to modified Wallace criteria1) is not reached, a TNF-inhibitor will be started.

Main study endpoint: The number of patients with inactive disease after 6 months of treatment.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study focuses on the treatment of JIA and can therefore only be performed in children (2-16 years old). During the study, blood sampling and visits to the outpatient clinic are part of regular care. The side effects of polytherapy are expected to be similar or slightly increased compared to methotrexate monotherapy. Polytherapy may lead to earlier achievement of inactive disease and therefore no need to administer methotrexate subcutaneously or to switch to (subcutaneous) biologic treatment.
- Main changes (audit trail)
- RECORD1-jun-2016 - 16-okt-2016


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