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

NCT00279747 | Completed Phase 3

• 1 other identifier: 107.208
• Study Type: interventional
• Target: 226
• Locations: 7 countries
• Sites: 34

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.

Conditions

Arthritis, Juvenile Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Response rates according to ACR Ped 30

  after 12 weeks of treatment

Secondary Outcomes (22)

• Global assessment of overall disease activity by investigator

  up to 12 months

• Parent global assessment of overall well-being

  up to 12 months

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

  up to 12 months

• Number of joints with active arthritis

  up to 12 months

• Number of joints with limited range of motion

  up to 12 months

Interventions

meloxicam 0.25 mg/kg DRUG

meloxicam 0.125 mg/kg DRUG

naproxen 10 mg/kg DRUG

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Patients with systemic course of JRA (intermittent fever with or without rash or other organ involvement) or with current systemic involvement
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (34)

Landes-Kinderklinik Linz

Linz, 4020, Austria

Location

Univ.-Klinik für Kinder- und Jugendheilkunde Wien

Vienna, 1090, Austria

Location

Gottfried Preyersches Kinderspital d. Stadt Wien

Vienna, 1100 Wien, Austria

Location

UZ Gent

Ghent, 9000, Belgium

Location

U.Z. Gasthuisberg

Leuven, 3000, Belgium

Location

Boehringer Ingelheim Investigational Site

Merksem, 2170, Belgium

Location

Boehringer Ingelheim Investigational Site

Angers, France

Location

Boehringer Ingelheim Investigational Site

Lille, France

Location

Boehringer Ingelheim Investigational Site

Marseille, France

Location

Boehringer Ingelheim Investigational Site

Paris, France

Location

Boehringer Ingelheim Investigational Site

Strasbourg, France

Location

Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, France

Location

Rheumaklinik Bad Bramstedt GmbH

Bad Bramstedt, 24572, Germany

Location

Neurologie

Bremen, 28325, Germany

Location

Universität Erlangen

Erlangen, 91054, Germany

Location

Martin-Luther-Universität Halle

Halle, 06097, Germany

Location

Boehringer Ingelheim Investigational Site

Hamburg, 22081, Germany

Location

Bayrische Julius-Maximilians-Universität

Würzburg, 97080, Germany

Location

Ospedale Meyer

Florence, 50132, Italy

Location

Istituto G. Gaslini

Genova, 16147, Italy

Location

Istituto Ortopedico Gaetano Pini

Milan, 20122, Italy

Location

II Università degli Studi di Napoli

Napoli, 80129, Italy

Location

Università Federico II

Napoli, 80131, Italy

Location

Clinica Pediatrica I

Padua, 35128, Italy

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Ospedale Pediatrico Bambin Gesù

Roma, 00165, Italy

Location

IRCCS Burlo Garofalo

Trieste, 34137, Italy

Location

Institute of Rheumatology of RAMN

Moscow, 115522, Russia

Location

Medical Faculty of Russian People Friendship University

Moscow, 117049, Russia

Location

Scientific Research Institute of Pediatric Hematology

Moscow, 117513, Russia

Location

Medical Academy Setchenov

Moscow, 119435, Russia

Location

Dept. of Child Health

London, WC1N 3JH, United Kingdom

Location

Booth Hall Childrens Hospital

Manchester, M9 7AA, United Kingdom

Location

Paediatric Department

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Meloxicam; Naproxen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Pharma GmbH & Co. KG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 19, 2006
• First Posted: January 20, 2006
• Study Start: September 1, 2000
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2003
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DE (6); AU (3); BE (3); IT (9); RU (4); FR (6); GB (3)