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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Arthritis, Juvenile Rheumatoid

Treatments

Drug: meloxicam 0.25 mg/kg

Drug: naproxen 10 mg/kg

Drug: meloxicam 0.125 mg/kg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00279747

107.208

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

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