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Arthritis, Juvenile RheumatoidPhase 3NCT00279747

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

A Phase 3 study testing meloxicam 0.25 mg/kg, meloxicam 0.125 mg/kg and naproxen 10 mg/kg in people with Arthritis, Juvenile Rheumatoid, run by Boehringer Ingelheim at 34 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 16 years
Conditions the study is for
Arthritis, Juvenile Rheumatoid
What is being tested?
meloxicam 0.25 mg/kg, meloxicam 0.125 mg/kg and naproxen 10 mg/kg
How many people
226 participants
Where
34 sitesin 7 countries
Study dates
Sep 2000to Jan 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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)
Show all 19Show fewer
  • 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

Trial locations and contacts

34 sites in 7 countries.

34 sites in 7 countries

Italy9 sites

  • Ospedale Meyer

    Florence, 50132

  • Istituto G. Gaslini

    Genova, 16147

  • Istituto Ortopedico Gaetano Pini

    Milan, 20122

  • II Università degli Studi di Napoli

    Naples, 80129

  • Università Federico II

    Naples, 80131

  • Clinica Pediatrica I

    Padova, 35128

  • IRCCS Policlinico San Matteo

    Pavia, 27100

  • Ospedale Pediatrico Bambin Gesù

    Roma, 00165

  • IRCCS Burlo Garofalo

    Trieste, 34137

Other trials in Italy

France6 sites

  • Boehringer Ingelheim Investigational Site

    Angers

  • Boehringer Ingelheim Investigational Site

    Lille

  • Boehringer Ingelheim Investigational Site

    Marseille

  • Boehringer Ingelheim Investigational Site

    Paris

  • Boehringer Ingelheim Investigational Site

    Strasbourg

  • Boehringer Ingelheim Investigational Site

    Vandœuvre-lès-Nancy

Other trials in France

Germany6 sites

  • Rheumaklinik Bad Bramstedt GmbH

    Bad Bramstedt, 24572

  • Neurologie

    Bremen, 28325

  • Universität Erlangen

    Erlangen, 91054

  • Martin-Luther-Universität Halle

    Halle, 06097

  • Boehringer Ingelheim Investigational Site

    Hamburg, 22081

  • Bayrische Julius-Maximilians-Universität

    Würzburg, 97080

Other trials in Germany

Russia4 sites

  • Institute of Rheumatology of RAMN

    Moscow, 115522

  • Medical Faculty of Russian People Friendship University

    Moscow, 117049

  • Scientific Research Institute of Pediatric Hematology

    Moscow, 117513

  • Medical Academy Setchenov

    Moscow, 119435

Other trials in Russia

Austria3 sites

  • Landes-Kinderklinik Linz

    Linz, 4020

  • Univ.-Klinik für Kinder- und Jugendheilkunde Wien

    Vienna, 1090

  • Gottfried Preyersches Kinderspital d. Stadt Wien

    Vienna, 1100 Wien

Other trials in Austria

Belgium3 sites

  • UZ Gent

    Ghent, 9000

  • U.Z. Gasthuisberg

    Leuven, 3000

  • Boehringer Ingelheim Investigational Site

    Merksem, 2170

Other trials in Belgium

United Kingdom3 sites

  • Dept. of Child Health

    London, WC1N 3JH

  • Booth Hall Childrens Hospital

    Manchester, M9 7AA

  • Paediatric Department

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
meloxicam 0.25 mg/kg, meloxicam 0.125 mg/kg, naproxen 10 mg/kg
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • meloxicam 0.25 mg/kgDrug

  • meloxicam 0.125 mg/kgDrug

  • naproxen 10 mg/kgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rates according to ACR Ped 30

    Measured: after 12 weeks of treatment

Secondary outcomes (22)

  1. Global assessment of overall disease activity by investigator

    Measured: up to 12 months

  2. Parent global assessment of overall well-being

    Measured: up to 12 months

  3. Assessment of functional disability by means of Childhood Health Assessment Questionnaire (CHAQ)

    Measured: up to 12 months

  4. Number of joints with active arthritis

    Measured: up to 12 months

  5. Number of joints with limited range of motion

    Measured: up to 12 months

  6. Erythrocyte Sedimentation Rate (ESR)

    Measured: up to 12 months

  7. Parent global assessment of arthritis

    Measured: up to 12 months

  8. Parent global assessment of pain

    Measured: up to 12 months

  9. Children's assessment of discomfort

    Measured: up to 12 months

  10. Change in functional classification (Steinbrocker classification)

    Measured: up to 12 months

  11. Final global assessment of efficacy by parent

    Measured: week 12, 12 months

  12. Final global assessment of efficacy by investigator

    Measured: week 12, 12 months

  13. Withdrawals due to inadequate efficacy

    Measured: up to 12 months

  14. Paracetamol / acetaminophen consumption

    Measured: up to 12 months

  15. Final global assessment of tolerability by parent

    Measured: week 12, 12 months

  16. Final global assessment of tolerability by investigator

    Measured: week 12, 12 months

  17. Incidence and intensity of adverse events (AEs)

    Measured: 12 months

  18. Incidence of laboratory adverse events

    Measured: 12 months

  19. Withdrawal due to adverse event

    Measured: 12 months

  20. Duration of hospital stay due to gastrointestinal serious adverse event (GI-SAE)

    Measured: week 12, 12 months

  21. Duration of hospital stay due to adverse events related to trial drug administration

    Measured: week 12, 12 months

  22. Additional visits to a physician due to gastrointestinal adverse event (GI-AE)

    Measured: week 12, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2006 (estimated)
  2. Study startSep 2000
  3. Primary completionJan 2003
  4. Study completionJan 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
226 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00279747
Sponsor's protocol ID
107.208
Status last verified
Oct 2013
First submitted
19 Jan 2006
Last updated
1 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing meloxicam 0.25 mg/kg, meloxicam 0.125 mg/kg and naproxen 10 mg/kg in people with Arthritis, Juvenile Rheumatoid, run by Boehringer Ingelheim at 34 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Italy, France, Germany, Russia, Austria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rates according to ACR Ped 30 (time frame: after 12 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00279747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.

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