Status:
COMPLETED
A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Arthritis, Juvenile Rheumatoid
Eligibility:
All Genders
2-16 years
Phase:
PHASE3
Brief Summary
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 a...
Detailed Description
Objective: In an international, multicenter, double-blind, randomized clinical trial we evaluated the short-term (3 months) and long term (12 months) efficacy and safety of two doses of meloxicam oral...
Eligibility Criteria
Inclusion
- 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
- 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)
- Treatment with hydroxychloroquine at a dose higher than 10 mg/kg/day
- Treatment with cyclosporine at a dose higher than 5 mg/kg/day
- Treatment with methotrexate at a dose higher than 15 mg/m2/week
- Treatment with other cytotoxic agents, gold compounds, D-penicillamine, Enbrel (etanercept), biologic agents and experimentals
- Intra-articular injections of corticosteroids during the last month prior to study entry and intended injections during the first 4 weeks of the trial treatment period
- Concomitant administration of other NSAIDs (including topical forms for skin with exception of local therapy for uveitis) or analgesic agents except paracetamol or acetaminophen
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
End Date :
January 1 2003
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00279747
Start Date
September 1 2000
End Date
January 1 2003
Last Update
November 1 2013
Active Locations (34)
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1
Landes-Kinderklinik Linz
Linz, Austria, 4020
2
Univ.-Klinik für Kinder- und Jugendheilkunde Wien
Vienna, Austria, 1090
3
Gottfried Preyersches Kinderspital d. Stadt Wien
Vienna, Austria, 1100 Wien
4
UZ Gent
Ghent, Belgium, 9000