A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)
- Conditions
- Arthritis, Juvenile Rheumatoid
- Registration Number
- NCT00279747
- Lead Sponsor
- Boehringer Ingelheim
- 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 administered twice daily in children with Juvenile Rheumatoid Arthritis.
- 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 suspension compared with naproxen in children with oligo and polyarticular course juvenile idiopathic arthritis (JIA).
Methods: Children with active oligo or polyarticular course JIA, requiring therapy with an NSAID were eligible for this trial. Patients were randomly allocated to therapy with meloxicam oral suspension 0.125 mg/kg body weight in single daily dose, meloxicam 0.25 mg/kg body weight in single daily dose, or naproxen 10 mg/kg body weight in two daily doses. The trial drugs were administered in a double-blind, double-dummy design for up to 12 months. Response rates were determined according to the American College of Rheumatology Pediatric 30% definition of improvement (ACR Ped 30). Safety parameters were assessed by evaluation of the adverse events in the 3 groups.
Study Hypothesis:
The null hypothesis of interest is that the magnitude of response with regard to the primary endpoint is equivalent between the treatment groups. The alternative is that there is any difference (two-sided) between any of the treatment groups.
Comparison(s):
Naproxen oral suspension 10 mg/kg body weight.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 226
-
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)
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Response rates according to ACR Ped 30 after 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Parent global assessment of pain up to 12 months Children's assessment of discomfort up to 12 months Additional visits to a physician due to gastrointestinal adverse event (GI-AE) week 12, 12 months Final global assessment of tolerability by parent week 12, 12 months Final global assessment of tolerability by investigator week 12, 12 months Incidence and intensity of adverse events (AEs) 12 months Incidence of laboratory adverse events 12 months Withdrawal due to adverse event 12 months Duration of hospital stay due to gastrointestinal serious adverse event (GI-SAE) week 12, 12 months Duration of hospital stay due to adverse events related to trial drug administration week 12, 12 months Erythrocyte Sedimentation Rate (ESR) up to 12 months Parent global assessment of arthritis up to 12 months Global assessment of overall disease activity by investigator up to 12 months Parent global assessment of overall well-being up to 12 months Assessment of functional disability by means of Childhood Health Assessment Questionnaire (CHAQ) up to 12 months Number of joints with active arthritis up to 12 months Number of joints with limited range of motion up to 12 months Change in functional classification (Steinbrocker classification) up to 12 months Final global assessment of efficacy by parent week 12, 12 months Final global assessment of efficacy by investigator week 12, 12 months Withdrawals due to inadequate efficacy up to 12 months Paracetamol / acetaminophen consumption up to 12 months
Trial Locations
- Locations (27)
Univ.-Klinik für Kinder- und Jugendheilkunde Wien
🇦🇹Wien, Austria
Gottfried Preyersches Kinderspital d. Stadt Wien
🇦🇹Wien, Austria
UZ Gent
🇧🇪Gent, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Rheumaklinik Bad Bramstedt GmbH
🇩🇪Bad Bramstedt, Germany
Neurologie
🇩🇪Bremen, Germany
Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
Universität Erlangen
🇩🇪Erlangen, Germany
Martin-Luther-Universität Halle
🇩🇪Halle/Saale, Germany
Bayrische Julius-Maximilians-Universität
🇩🇪Würzburg, Germany
Istituto G. Gaslini
🇮🇹Genova, Italy
Istituto Ortopedico Gaetano Pini
🇮🇹Milano, Italy
II Università degli Studi di Napoli
🇮🇹Napoli, Italy
IRCCS Burlo Garofalo
🇮🇹Trieste, Italy
Ospedale Pediatrico Bambin Gesù
🇮🇹Roma, Italy
IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Medical Faculty of Russian People Friendship University
🇷🇺Moscow, Russian Federation
Scientific Research Institute of Pediatric Hematology
🇷🇺Moscow, Russian Federation
Paediatric Department
🇬🇧Wolverhampton, United Kingdom
Clinica Pediatrica I
🇮🇹Padova, Italy
Dept. of Child Health
🇬🇧London, United Kingdom
Landes-Kinderklinik Linz
🇦🇹Linz, Austria
Ospedale Meyer
🇮🇹Firenze, Italy
Università Federico II
🇮🇹Napoli, Italy
Medical Academy Setchenov
🇷🇺Moscow, Russian Federation
Institute of Rheumatology of RAMN
🇷🇺Moscow, Russian Federation
Booth Hall Childrens Hospital
🇬🇧Manchester, United Kingdom