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

Primary Purpose

Arthritis, Juvenile Rheumatoid

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
meloxicam 0.25 mg/kg
meloxicam 0.125 mg/kg
naproxen 10 mg/kg
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Landes-Kinderklinik Linz
  • Univ.-Klinik für Kinder- und Jugendheilkunde Wien
  • Gottfried Preyersches Kinderspital d. Stadt Wien
  • UZ Gent
  • U.Z. Gasthuisberg
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Rheumaklinik Bad Bramstedt GmbH
  • Neurologie
  • Universität Erlangen
  • Martin-Luther-Universität Halle
  • Boehringer Ingelheim Investigational Site
  • Bayrische Julius-Maximilians-Universität
  • Ospedale Meyer
  • Istituto G. Gaslini
  • Istituto Ortopedico Gaetano Pini
  • II Università degli Studi di Napoli
  • Università Federico II
  • Clinica Pediatrica I
  • IRCCS Policlinico San Matteo
  • Ospedale Pediatrico Bambin Gesù
  • IRCCS Burlo Garofalo
  • Institute of Rheumatology of RAMN
  • Medical Faculty of Russian People Friendship University
  • Scientific Research Institute of Pediatric Hematology
  • Medical Academy Setchenov
  • Dept. of Child Health
  • Booth Hall Childrens Hospital
  • Paediatric Department

Outcomes

Primary Outcome Measures

Response rates according to ACR Ped 30

Secondary Outcome Measures

Global assessment of overall disease activity by investigator
Parent global assessment of overall well-being
Assessment of functional disability by means of Childhood Health Assessment Questionnaire (CHAQ)
Number of joints with active arthritis
Number of joints with limited range of motion
Erythrocyte Sedimentation Rate (ESR)
Parent global assessment of arthritis
Parent global assessment of pain
Children's assessment of discomfort
Change in functional classification (Steinbrocker classification)
Final global assessment of efficacy by parent
Final global assessment of efficacy by investigator
Withdrawals due to inadequate efficacy
Paracetamol / acetaminophen consumption
Final global assessment of tolerability by parent
Final global assessment of tolerability by investigator
Incidence and intensity of adverse events (AEs)
Incidence of laboratory adverse events
Withdrawal due to adverse event
Duration of hospital stay due to gastrointestinal serious adverse event (GI-SAE)
Duration of hospital stay due to adverse events related to trial drug administration
Additional visits to a physician due to gastrointestinal adverse event (GI-AE)

Full Information

First Posted
January 19, 2006
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00279747
Brief Title
A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
226 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
meloxicam 0.25 mg/kg
Intervention Type
Drug
Intervention Name(s)
meloxicam 0.125 mg/kg
Intervention Type
Drug
Intervention Name(s)
naproxen 10 mg/kg
Primary Outcome Measure Information:
Title
Response rates according to ACR Ped 30
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Global assessment of overall disease activity by investigator
Time Frame
up to 12 months
Title
Parent global assessment of overall well-being
Time Frame
up to 12 months
Title
Assessment of functional disability by means of Childhood Health Assessment Questionnaire (CHAQ)
Time Frame
up to 12 months
Title
Number of joints with active arthritis
Time Frame
up to 12 months
Title
Number of joints with limited range of motion
Time Frame
up to 12 months
Title
Erythrocyte Sedimentation Rate (ESR)
Time Frame
up to 12 months
Title
Parent global assessment of arthritis
Time Frame
up to 12 months
Title
Parent global assessment of pain
Time Frame
up to 12 months
Title
Children's assessment of discomfort
Time Frame
up to 12 months
Title
Change in functional classification (Steinbrocker classification)
Time Frame
up to 12 months
Title
Final global assessment of efficacy by parent
Time Frame
week 12, 12 months
Title
Final global assessment of efficacy by investigator
Time Frame
week 12, 12 months
Title
Withdrawals due to inadequate efficacy
Time Frame
up to 12 months
Title
Paracetamol / acetaminophen consumption
Time Frame
up to 12 months
Title
Final global assessment of tolerability by parent
Time Frame
week 12, 12 months
Title
Final global assessment of tolerability by investigator
Time Frame
week 12, 12 months
Title
Incidence and intensity of adverse events (AEs)
Time Frame
12 months
Title
Incidence of laboratory adverse events
Time Frame
12 months
Title
Withdrawal due to adverse event
Time Frame
12 months
Title
Duration of hospital stay due to gastrointestinal serious adverse event (GI-SAE)
Time Frame
week 12, 12 months
Title
Duration of hospital stay due to adverse events related to trial drug administration
Time Frame
week 12, 12 months
Title
Additional visits to a physician due to gastrointestinal adverse event (GI-AE)
Time Frame
week 12, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Pharma GmbH & Co. KG
Official's Role
Study Chair
Facility Information:
Facility Name
Landes-Kinderklinik Linz
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Univ.-Klinik für Kinder- und Jugendheilkunde Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Gottfried Preyersches Kinderspital d. Stadt Wien
City
Wien
ZIP/Postal Code
1100 Wien
Country
Austria
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Boehringer Ingelheim Investigational Site
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Boehringer Ingelheim Investigational Site
City
Angers
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Lille
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Vandoeuvre les Nancy
Country
France
Facility Name
Rheumaklinik Bad Bramstedt GmbH
City
Bad Bramstedt
ZIP/Postal Code
24572
Country
Germany
Facility Name
Neurologie
City
Bremen
ZIP/Postal Code
28325
Country
Germany
Facility Name
Universität Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Martin-Luther-Universität Halle
City
Halle/Saale
ZIP/Postal Code
06097
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Bayrische Julius-Maximilians-Universität
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Ospedale Meyer
City
Firenze
ZIP/Postal Code
50132
Country
Italy
Facility Name
Istituto G. Gaslini
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Istituto Ortopedico Gaetano Pini
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
II Università degli Studi di Napoli
City
Napoli
ZIP/Postal Code
80129
Country
Italy
Facility Name
Università Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Clinica Pediatrica I
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale Pediatrico Bambin Gesù
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
IRCCS Burlo Garofalo
City
Trieste
ZIP/Postal Code
34137
Country
Italy
Facility Name
Institute of Rheumatology of RAMN
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Medical Faculty of Russian People Friendship University
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
Scientific Research Institute of Pediatric Hematology
City
Moscow
ZIP/Postal Code
117513
Country
Russian Federation
Facility Name
Medical Academy Setchenov
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
Dept. of Child Health
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Booth Hall Childrens Hospital
City
Manchester
ZIP/Postal Code
M9 7AA
Country
United Kingdom
Facility Name
Paediatric Department
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.208_U03-1727.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.208_literature.pdf
Description
Related Info

Learn more about this trial

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

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