A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)

NCT ID: NCT00279747

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2003-01-31

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.

Conditions

Arthritis, Juvenile Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

meloxicam 0.25 mg/kg

Intervention Type: DRUG

meloxicam 0.125 mg/kg

Intervention Type: DRUG

naproxen 10 mg/kg

Intervention Type: DRUG

Eligibility Criteria

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)

• 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

Exclusion Criteria

• Patients with systemic course of JRA (intermittent fever with or without rash or other organ involvement) or with current systemic involvement

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Pharma GmbH & Co. KG

Locations

Landes-Kinderklinik Linz

Linz, , Austria

Univ.-Klinik für Kinder- und Jugendheilkunde Wien

Vienna, , Austria

Gottfried Preyersches Kinderspital d. Stadt Wien

Vienna, , Austria

UZ Gent

Ghent, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

Boehringer Ingelheim Investigational Site

Merksem, , Belgium

Boehringer Ingelheim Investigational Site

Angers, , France

Boehringer Ingelheim Investigational Site

Lille, , France

Boehringer Ingelheim Investigational Site

Marseille, , France

Boehringer Ingelheim Investigational Site

Paris, , France

Boehringer Ingelheim Investigational Site

Strasbourg, , France

Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

Rheumaklinik Bad Bramstedt GmbH

Bad Bramstedt, , Germany

Neurologie

Bremen, , Germany

Universität Erlangen

Erlangen, , Germany

Martin-Luther-Universität Halle

Halle, , Germany

Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Bayrische Julius-Maximilians-Universität

Würzburg, , Germany

Ospedale Meyer

Florence, , Italy

Istituto G. Gaslini

Genova, , Italy

Istituto Ortopedico Gaetano Pini

Milan, , Italy

II Università degli Studi di Napoli

Napoli, , Italy

Università Federico II

Napoli, , Italy

Clinica Pediatrica I

Padua, , Italy

IRCCS Policlinico San Matteo

Pavia, , Italy

Ospedale Pediatrico Bambin Gesù

Roma, , Italy

IRCCS Burlo Garofalo

Trieste, , Italy

Institute of Rheumatology of RAMN

Moscow, , Russia

Medical Faculty of Russian People Friendship University

Moscow, , Russia

Scientific Research Institute of Pediatric Hematology

Moscow, , Russia

Medical Academy Setchenov

Moscow, , Russia

Dept. of Child Health

London, , United Kingdom

Booth Hall Childrens Hospital

Manchester, , United Kingdom

Paediatric Department

Wolverhampton, , United Kingdom

Countries

Austria; Belgium; France; Germany; Italy; Russia; United Kingdom

Other Identifiers

107.208

Identifier Type: -

Identifier Source: org_study_id