Official Title: “A One Year Double-Blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: meloxicam 0.25 mg/kg
• Drug: meloxicam 0.125 mg/kg
• Drug: naproxen 10 mg/kg

Primary Measures

• Response rates according to ACR Ped 30

Secondary Measures

• 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

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)
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair B.I. Pharma GmbH & Co. KG  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00279747

Study ID Number: 107.208

ClinicalTrials.gov Identifier: NCT00279747

Health Authority: Germany: Ministry of Health