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Arthritis, RheumatoidPhase 3NCT00042068

A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis

A Phase 3 study testing Meloxicam in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim at 153 sites in 14 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 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Meloxicam
How many people
1,000 participants
Where
153 sitesin 14 countries
Study dates
Jun 2002to Jul 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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age greater than or equal to 18 and less than or equal to 80
  • Diagnosis of Rheumatoid Arthritis for at least six weeks
  • Taking an NSAID
  • If female: using adequate contraception
  • Willingness to stop current NSAID until criteria reached to begin study drug
  • Able to provide written informed consent

Who cannot join

  • Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug
  • Pregnancy, lactating
  • Use of investigational drug within 30 days prior to entering the trial
  • History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding
  • History of cerebrovascular or other bleeding disorder
  • Severe hypertension
Show all 16Show fewer
  • Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion)
  • RA of functional class IV
  • Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial
  • Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day)
  • DMARDs initiated within past three months or dose changed less than two months before entering the trial
  • Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial
  • Concomitant therapy with ACTH within past month before entering the trial.
  • History of narcotic or alcohol abuse (past 12 months)
  • Abnormal laboratory values
  • Previous participation in the present trial

Trial locations and contacts

153 sites in 14 countries.

153 sites in 14 countries

United States72 sites

  • Suite 140

    Anchorage, Alaska, 99508

  • Boehringer Ingelheim Investigational Site

    Austin, Texas, 78705

  • Boehringer Ingelheim Investigational Site

    Camp Hill, Pennsylvania, 17011

  • Suite 100

    Charlotte, North Carolina, 28210

  • Boehringer Ingelheim Investigational Site

    Coeur d'Alene, Idaho, 83814-2644

  • Suite 200

    Colorado Springs, Colorado, 80910

  • Boehringer Ingelheim Investigational Site

    Columbia, South Carolina, 29204

  • Boehringer Ingelheim Investigational Site

    Columbus, Ohio, 43214

  • Boehringer Ingelheim Investigational Site

    Dallas, Texas, 75225

  • Radiant Research

    Dallas, Texas, 75231

  • Suite 200

    Dallas, Texas, 75246-1632

  • Suites 205 & 206

    Danbury, Connecticut, 06810

  • Boehringer Ingelheim Investigational Site

    Delray Beach, Florida, 33484

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Boehringer Ingelheim Investigational Site

    Erie, Pennsylvania, 16508-1256

  • Boehringer Ingelheim Investigational Site

    Everett, Washington, 98201

  • Truesdale Clinic

    Fall River, Massachusetts, 02720

  • Suite 2A

    Falls Church, Virginia, 22044

  • Boehringer Ingelheim Investigational Site

    Gainsville, Florida, 32607

  • #106

    Glendale, Arizona, 85308

  • Suites 570 (research) & 600 (PI)

    Huntsville, Alabama, 35801

  • Suite 202

    Idaho Falls, Idaho, 83404

  • Boehringer Ingelheim Investigational Site

    Indianapolis, Indiana, 46202

  • Boehringer Ingelheim Investigational Site

    Jacksonville, Florida, 32204

  • Suite 331-333

    Johnston, Rhode Island, 02919

  • Suite 202

    Kalamazoo, Michigan, 49009

  • Boehringer Ingelheim Investigational Site

    Lake Forest, Illinois, 60045

  • Boehringer Ingelheim Investigational Site

    Largo, Florida, 33773

  • Boehringer Ingelheim Investigational Site

    Lincoln, Nebraska, 68506

  • Boehringer Ingelheim Investigational Site

    Los Angeles, California, 90048

  • Suite 500

    Lubbock, Texas, 79410

  • Suite D

    Mechanicsburg, Pennsylvania, 17055

  • PC, Jackson Commons D-2

    Medford, New Jersey, 08055

  • Suite 8

    Mercerville, New Jersey, 08619

  • Suite 202

    Miami, Florida, 33173

  • Suite 200

    Montgomery, Alabama, 36106

  • Boehringer Ingelheim Investigational Site

    New York, New York, 10021

  • Suite H

    North Charleston, South Carolina, 29406

  • Boehringer Ingelheim Investigational Site

    Ocala, Florida, 03474

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Boehringer Ingelheim Investigational Site

    Orangeburg, South Carolina, 29118

  • Boehringer Ingelheim Investigational Site

    Orlando, Florida, 32804

  • Suite 2

    Orlando, Florida, 32806

  • Boehringer Ingelheim Investigational Site

    Pasadena, California, 91105

  • Suite 601

    Phoenix, Arizona, 85012

  • Suite 201

    Phoenix, Arizona, 85015

  • Suite 100

    Rancho Cucamonga, California, 91730

  • Boehringer Ingelheim Investigational Site

    Rancho Mirage, California, 92270-4469

  • Boehringer Ingelheim Investigational Site

    Reno, Nevada, 89502-1196

  • Boehringer Ingelheim Investigational Site

    Rockford, Illinois, 61103

  • Suite 406

    Safety Harbor, Florida, 34695

  • Suites 207

    San Antonio, Texas, 78217

  • Suite 208

    San Diego, California, 92108

  • Suite 202

    San Diego, California, 92120

  • Suite 301

    San Leandro, California, 94578

  • Suite A

    Santa Maria, California, 93454

  • Boehringer Ingelheim Investigational Site

    Sarasota, Florida, 34239

  • Suite D-3

    Seattle, Washington, 98166-2967

  • Boehringer Ingelheim Investigational Site

    South Miami, Florida, 33143

  • Boehringer Ingelheim Investigational Site

    Springfield, Illinois, 62704

  • Suite 101

    St Louis, Missouri, 63128

  • Suite 240

    St Louis, Missouri, 63141

  • Suite 101

    St. Petersburg, Florida, 33710

  • Radiant Research

    Stuart, Florida, 34996

  • Suite 203

    Tampa, Florida, 33614

  • Boehringer Ingelheim Investigational Site

    Tulsa, Oklahoma, 74135

  • Suite 300

    Washington D.C., District of Columbia, 20006

  • Westlake Medical Research

    Westlake Village, California, 91361

  • Suite 306

    Wheaton, Maryland, 20902

  • Attn: Kathy Stoddard, Director

    Wichita, Kansas, 67207

  • Boehringer Ingelheim Investigational Site

    Yakima, Washington, 98902

  • Boehringer Ingelheim Investigational Site

    Zephyrhills, Florida, 33540

Other trials in United States

Canada17 sites

  • Boehringer Ingelheim Investigational Site

    Corunna, Ontario, N0N 1G0

  • Boehringer Ingelheim Investigational Site

    Fort Erie, Ontario, L2A 1Z3

  • Boehringer Ingelheim Investigational Site

    Hamilton, Ontario, L8N 1Y2

  • Dr. Denis O'Donnell

    Kingston, Ontario, K7L 2V6

  • Trillium Health Centre

    Mississauga, Ontario, L5B 4A2

  • Boehringer Ingelheim Investigational Site

    Montreal, Quebec, H3G 1A4

  • Boehringer Ingelheim Investigational Site

    Montreal, Quebec, H3Z, 2Z3

  • Boehringer Ingelheim Investigational Site

    Ottawa, Ontario, K2P 1V3

  • Boehringer Ingelheim Investigational Site

    Peterborough, Ontario, K9J 7H8

  • Boehringer Ingelheim Investigational Site

    Pointe-Claire, Quebec, H9R 3J1

  • 230-6091

    Richmond, British Columbia, V7C 5L9

  • Boehringer Ingelheim Investigational Site

    Sarnia, Ontario, N7T 4X3

  • Boehringer Ingelheim Investigational Site

    Scarborough Village, Ontario, M1B 4Y9

  • 104-532

    St. Catharines, Ontario, L2N 4H4

  • Boehringer Ingelheim Investigational Site

    Toronto, Ontario, M3B 2H9

  • Boehringer Ingelheim Investigational Site

    Victoria, British Columbia, V8P 5P6

  • Boehringer Ingelheim Investigational Site

    Windsor, Ontario, N8W 5L7

Other trials in Canada

Germany14 sites

  • Boehringer Ingelheim Investigational Site

    Aachen, 52064

  • Augusta-Klinik

    Bad Kreuznach, 55543

  • Boehringer Ingelheim Investigational Site

    Bad Segeberg, 23795

  • Rheumatologie und Physikalische Therapie

    Berlin, 14059

  • Boehringer Ingelheim Investigational Site

    Ellefeld, 08236

  • Elisabeth-Krankenhaus

    Essen, 45356

  • Boehringer Ingelheim Investigational Site

    Klotten, 56818

  • ClinPharm International GmbH & Co. KG

    Leipzig, 04229

  • Boehringer Ingelheim Investigational Site

    München, 81541

  • Boehringer Ingelheim Investigational Site

    Nuremberg, 90402

  • Boehringer Ingelheim Investigational Site

    Nuremberg, 90461

  • Boehringer Ingelheim Investigational Site

    Steinhöring, 85643

  • Boehringer Ingelheim Investigational Site

    Tübingen, 72070

  • Klinik für Rheumatologie,

    Wiesbaden, 65191

Other trials in Germany

Hungary9 sites

  • National Institute for Rheumatology and Physiotherapy

    Budapest, 1027

  • DOTE

    Debrecen, 4031

  • Aladár Petz County Hospital

    Győr, 9024

  • St. Andrew State Hospital

    Hévíz, 8380

  • St. Ferenc Hospital

    Miskolc, 3501

  • Pál Almási Balogh Hospital

    Ózd, 3601

  • Hungarian Brothers of St. John of Good

    Pécs, 7621

  • Szegedi University

    Szeged, 6720

  • Ferenc Csolnoky County Hospital

    Veszprém, 8201

Other trials in Hungary

Ukraine9 sites

  • Dnyepropyetrovsk Medical Academy

    Dnyepropetrovsk, 49044

  • Central City Hospital

    Donetsk, 83098

  • State Medical University

    Donetsk, 83114

  • Municipal Institute of Health Care

    Kharkiv, 61091

  • City Multitype Clinical Hospital No. 25

    Kharkiv, 61115

  • Central Clinical Hospital

    Kiev, 01023

  • Institute of Cardiology

    Kiev, 03151

  • Regional Hospital No. 1

    Kiev, 04107

  • Institute of Gerontology

    Kyiv, 04114

Other trials in Ukraine

South Korea5 sites

  • 896 Pyung Chon-Dong, Dongan-Gu

    Gyeonggi-do, 431-070

  • San-5, Woncheon-Dong, Paldal-Gu

    Gyeonggi-do, 442-721

  • 85 Jeo-Dong 2Ga

    Seoul, 100-032

  • Seoul National University Hospital

    Seoul, 110-744

  • Boehringer Ingelheim Investigational Site

    Seoul, 120-752

Other trials in South Korea

Argentina4 sites

  • Boehringer Ingelheim Investigational Site

    Buenos Aires, 1405

  • Boehringer Ingelheim Investigational Site

    Buenos Aires, 1427

  • Boehringer Ingelheim Investigational Site

    Buenos Aires, 1428

  • Boehringer Ingelheim Investigational Site

    Rosario, 2000

Other trials in Argentina

Brazil4 sites

  • Av Anhanguera 6479

    Goiânia GO, 74043-011

  • Rua Ramiro Barcelos 2350

    Porto Alegre RS, 90035-003

  • Boehringer Ingelheim Investigational Site

    São Paulo - SP, 04040-000

  • Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia

    São Paulo - SP, 04230-000

Other trials in Brazil

France4 sites

  • Boehringer Ingelheim Investigational Site

    Marseille, 13008

  • Boehringer Ingelheim Investigational Site

    Nice, 06000

  • Boehringer Ingelheim Investigational Site

    Tours, 37000

  • Boehringer Ingelheim Investigational Site

    Tours, 37044

Other trials in France

Italy4 sites

  • Università degli Studi

    Genova

  • Ospedale Augusto Murri

    Iesi, 60035

  • Università degli Studi di Napoli "Federico II"

    Naples, 80131

  • Ospedale A. Galateo

    SAN Cesario (Lecce), 73016

Other trials in Italy

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • Rheumatology-Allergy-Immunology

    Kaohsiung City

  • Chang Gung Memorial Hospital

    Taipei, 105

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

Australia3 sites

  • Boehringer Ingelheim Investigational Site

    Cotton Tree, Queensland, 4558

  • Emeritus Research

    Malvern, Victoria, 3144

  • Department of Rheumatology

    Perth, Western Australia, 6004

Other trials in Australia

Belgium2 sites

  • Clinique du Parc Léopold

    Brussels, 1040

  • Medisch Centrum van Huisartsen

    Leuven, 3000

Other trials in Belgium

Russia2 sites

  • Institute of Rheumatology of RAMN

    Moscow, 115522

  • City Clinical Hospital No. 1

    Moscow, 117049

Other trials in Russia

About this study

Official title: A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis

A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.

Being tested
Meloxicam
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • MeloxicamDrug

What is being measured

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

  1. Response according to American College of Rheumatology 20% (ACR20) classification

    Measured: at 12 weeks

Secondary outcomes (17)

  1. Number of painful or tender joints

    Measured: up to 12 weeks

  2. Number of swollen joints

    Measured: up to 12 weeks

  3. Patient's global (overall) assessment of disease activity

    Measured: up to 12 weeks

  4. Investigator's global (overall) assessment of disease activity

    Measured: up to 12 weeks

  5. Patient's assessment of pain

    Measured: up to 12 weeks

  6. Patient's assessment of physical function (mHAQ)

    Measured: up to 12 weeks

  7. C-Reactive Protein (CRP)

    Measured: up to 12 weeks

  8. Withdrawal due to lack of efficacy

    Measured: up to 12 weeks

  9. Duration of morning stiffness

    Measured: up to of 12 weeks

  10. Patient's final global (overall) assessment of efficacy

    Measured: at end of 12 weeks

  11. Investigator's final global (overall) assessment of efficacy

    Measured: at end of 12 weeks

  12. Patient status with regard to change in arthritic condition

    Measured: at end of 12 weeks

  13. Use of rescue medication

    Measured: up to 12 weeks

  14. Incidence and intensity of adverse events

    Measured: until 4 weeks post treatment

  15. Patient's final global assessment of tolerability

    Measured: at end of 12 weeks

  16. Investigator's final global assessment of tolerability

    Measured: at end of 12 weeks

  17. Withdrawals due to adverse events

    Measured: at end of 12 weeks

Timeline

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

  1. First posted24 Jul 2002 (estimated)
  2. Study startJun 2002
  3. Study completionJul 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
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00042068
Sponsor's protocol ID
107.258
Status last verified
Oct 2013
First submitted
22 Jul 2002
Last updated
1 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meloxicam in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim at 153 sites in 14 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 6 inclusion and 16 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 153 sites in United States, Canada, Germany, Hungary, Ukraine and 9 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 according to American College of Rheumatology 20% (ACR20) classification (time frame: at 12 weeks). 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 NCT00042068.

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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