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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00279747
First received: January 19, 2006
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Arthritis, Juvenile Rheumatoid
Drug: meloxicam 0.25 mg/kg
Drug: meloxicam 0.125 mg/kg
Drug: naproxen 10 mg/kg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Response rates according to ACR Ped 30 [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global assessment of overall disease activity by investigator [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Parent global assessment of overall well-being [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Assessment of functional disability by means of Childhood Health Assessment Questionnaire (CHAQ) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Number of joints with active arthritis [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Number of joints with limited range of motion [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Parent global assessment of arthritis [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Parent global assessment of pain [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Children's assessment of discomfort [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Change in functional classification (Steinbrocker classification) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by parent [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Final global assessment of efficacy by investigator [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Withdrawals due to inadequate efficacy [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Paracetamol / acetaminophen consumption [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Final global assessment of tolerability by parent [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Final global assessment of tolerability by investigator [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events (AEs) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of laboratory adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Withdrawal due to adverse event [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Duration of hospital stay due to gastrointestinal serious adverse event (GI-SAE) [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Duration of hospital stay due to adverse events related to trial drug administration [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]
  • Additional visits to a physician due to gastrointestinal adverse event (GI-AE) [ Time Frame: week 12, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: September 2000
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279747

Locations
Austria
Landes-Kinderklinik Linz
Linz, Austria, 4020
Univ.-Klinik für Kinder- und Jugendheilkunde Wien
Wien, Austria, 1090
Gottfried Preyersches Kinderspital d. Stadt Wien
Wien, Austria, 1100 Wien
Belgium
UZ Gent
Gent, Belgium, 9000
U.Z. Gasthuisberg
Leuven, Belgium, 3000
Boehringer Ingelheim Investigational Site
Merksem, Belgium, 2170
France
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
Vandoeuvre les Nancy, France
Germany
Rheumaklinik Bad Bramstedt GmbH
Bad Bramstedt, Germany, 24572
Neurologie
Bremen, Germany, 28325
Universität Erlangen
Erlangen, Germany, 91054
Martin-Luther-Universität Halle
Halle/Saale, Germany, 06097
Boehringer Ingelheim Investigational Site
Hamburg, Germany, 22081
Bayrische Julius-Maximilians-Universität
Würzburg, Germany, 97080
Italy
Ospedale Meyer
Firenze, Italy, 50132
Istituto G. Gaslini
Genova, Italy, 16147
Istituto Ortopedico Gaetano Pini
Milano, Italy, 20122
II Università degli Studi di Napoli
Napoli, Italy, 80129
Università Federico II
Napoli, Italy, 80131
Clinica Pediatrica I
Padova, Italy, 35128
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Ospedale Pediatrico Bambin Gesù
Roma, Italy, 00165
IRCCS Burlo Garofalo
Trieste, Italy, 34137
Russian Federation
Institute of Rheumatology of RAMN
Moscow, Russian Federation, 115522
Medical Academy Setchenov
Moscow, Russian Federation, 119435
Scientific Research Institute of Pediatric Hematology
Moscow, Russian Federation, 117513
Medical Faculty of Russian People Friendship University
Moscow, Russian Federation, 117049
United Kingdom
Dept. of Child Health
London, United Kingdom, WC1N 3JH
Booth Hall Childrens Hospital
Manchester, United Kingdom, M9 7AA
Paediatric Department
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Pharma GmbH & Co. KG
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00279747     History of Changes
Other Study ID Numbers: 107.208
Study First Received: January 19, 2006
Last Updated: October 31, 2013
Health Authority: Germany: Ministry of Health
Austria: Ethikkommission
Russia: Ethics Committee
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Naproxen
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014