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Health Condition(s) or Problem
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Arthritis, Juvenile Rheumatoid
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Lay Summary
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A one year double-blind trial to investigate the efficacy and safety of meloxicam oral
suspension 0.25 mg/kg and 0.125 mg/kg administered once daily in comparison to naproxen oral
suspension 5 mg/kg administered twice daily in children with Juvenile Rheumatoid Arthritis.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Male or female outpatients and inpatients aged 2 to 16 years
- Diagnosis of idiopathic arthritis of childhood by ILAR criteria:
- Age of onset less than 16 years
- Arthritis in one or more joints defined as swelling, or - if no swelling is
present - limitation in range of joint movement with joint pain or tenderness,
which is not due to primary mechanical disorders
- Duration of the disease > 6 weeks
- Type of onset of disease during the first 6 months classified as polyarthritis
(5 joints or more; rheumatoid factor positive or negative), oligoarthritis (4
joints or fewer) or systemic arthritis
- Oligoarthritic, extended oligoarthritic or polyarthritic current course of disease
- Active arthritis as defined above of at least 2 joints
- At least 2 other abnormal variables of any of the 5 remaining core set parameters.
The physician and the parent ratings must be at least 10 mm on a 100 mm VAS scale and
the CHAQ score more than 0.
- Patients requiring therapy with NSAIDs, i.e., the patient fits into one of the
following categories:
- New onset patient
- Patient in remission, but experiencing a flare and now requiring an NSAID
- Patient with insufficient therapeutic effect (ITE) or intolerability to another
NSAID (other than Naproxen) and now must be changed
- Written informed permission given by the parent(s) or the subjects legally authorised
representative in accordance with local legislation and ICH GCP
- Active assent given by the patient if the child is capable of understanding the given
information (applies to children who have reached an intellectual age of 7 years or
greater)
Exclusion Criteria:
- Patients with systemic course of JRA (intermittent fever with or without rash or
other organ involvement) or with current systemic involvement
- All rheumatic diseases not covered by the inclusion criteria
- Any finding indicating that the patient has a clinically significant other disease
than JRA at the time of enrollment
- Patients with abnormal, clinically relevant laboratory values not related to their
JRA
- Pregnancy or breast feeding
- Women of childbearing potential not using adequate contraception precaution:
attention should be drawn to reports that NSAIDs were reported to decrease the
effectiveness of intrauterine devices (R95-0164)
- History of bleeding disorders, gastrointestinal bleeding or cerebrovascular bleeding
- Active peptic ulcer within the last 6 months
- Treatment with more than one SAARD/DMARD (slow-acting antirheumatic
drug/disease-modifying antirheumatic drug) during the last 3 months prior to study
entry
- Change in treatment with SAARDs/DMARDs during the last 3 months prior to study entry
or intended change during the trial duration
- Change in treatment with corticosteroids during the last month prior to study entry
or intended change during the trial duration with exception of local therapy for
uveitis
- One of the following therapies during the last 3 months prior to study entry or their
intended use during the trial treatment period
- Systemic treatment (except for intra-articular injections) with corticosteroids
at a dose higher than 10 mg/day or 0.2 mg/kg/day (prednisone equivalent),
respectively (whichever is lower)
- Treatmen
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Who cannot enter the trial
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Inclusion Criteria:
- Male or female outpatients and inpatients aged 2 to 16 years
- Diagnosis of idiopathic arthritis of childhood by ILAR criteria:
- Age of onset less than 16 years
- Arthritis in one or more joints defined as swelling, or - if no swelling is
present - limitation in range of joint movement with joint pain or tenderness,
which is not due to primary mechanical disorders
- Duration of the disease > 6 weeks
- Type of onset of disease during the first 6 months classified as polyarthritis
(5 joints or more; rheumatoid factor positive or negative), oligoarthritis (4
joints or fewer) or systemic arthritis
- Oligoarthritic, extended oligoarthritic or polyarthritic current course of disease
- Active arthritis as defined above of at least 2 joints
- At least 2 other abnormal variables of any of the 5 remaining core set parameters.
The physician and the parent ratings must be at least 10 mm on a 100 mm VAS scale and
the CHAQ score more than 0.
- Patients requiring therapy with NSAIDs, i.e., the patient fits into one of the
following categories:
- New onset patient
- Patient in remission, but experiencing a flare and now requiring an NSAID
- Patient with insufficient therapeutic effect (ITE) or intolerability to another
NSAID (other than Naproxen) and now must be changed
- Written informed permission given by the parent(s) or the subjects legally authorised
representative in accordance with local legislation and ICH GCP
- Active assent given by the patient if the child is capable of understanding the given
information (applies to children who have reached an intellectual age of 7 years or
greater)
Exclusion Criteria:
- Patients with systemic course of JRA (intermittent fever with or without rash or
other organ involvement) or with current systemic involvement
- All rheumatic diseases not covered by the inclusion criteria
- Any finding indicating that the patient has a clinically significant other disease
than JRA at the time of enrollment
- Patients with abnormal, clinically relevant laboratory values not related to their
JRA
- Pregnancy or breast feeding
- Women of childbearing potential not using adequate contraception precaution:
attention should be drawn to reports that NSAIDs were reported to decrease the
effectiveness of intrauterine devices (R95-0164)
- History of bleeding disorders, gastrointestinal bleeding or cerebrovascular bleeding
- Active peptic ulcer within the last 6 months
- Treatment with more than one SAARD/DMARD (slow-acting antirheumatic
drug/disease-modifying antirheumatic drug) during the last 3 months prior to study
entry
- Change in treatment with SAARDs/DMARDs during the last 3 months prior to study entry
or intended change during the trial duration
- Change in treatment with corticosteroids during the last month prior to study entry
or intended change during the trial duration with exception of local therapy for
uveitis
- One of the following therapies during the last 3 months prior to study entry or their
intended use during the trial treatment period
- Systemic treatment (except for intra-articular injections) with corticosteroids
at a dose higher than 10 mg/day or 0.2 mg/kg/day (prednisone equivalent),
respectively (whichever is lower)
- Treatmen
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What will happen
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Drug; meloxicam 0.25 mg/kg; Drug; meloxicam 0.125 mg/kg; Drug; naproxen 10 mg/kg
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Primary aim
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Response rates according to ACR Ped 30
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Secondary Aim
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Investigator global assessment of overall disease activity, parent global assessment of overall well-being, number of joints with active arthritis, number of joints with limited range of motion, assessment of functional disability by means of CHAQ
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.208_U03-1727.pdf; http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.208_literature.pdf
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Recruitment Status
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Completed
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Nation
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England
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Location
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London, Manchester, Wolverhampton
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