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

October 31, 2013 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Arthritis, Rheumatoid

Intervention / Treatment

Drug: Meloxicam

Study Type

Interventional

Enrollment

1000

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1405
    - Boehringer Ingelheim Investigational Site
  - Buenos Aires, Argentina, 1427
    - Boehringer Ingelheim Investigational Site
  - Buenos Aires, Argentina, 1428
    - Boehringer Ingelheim Investigational Site
  - Rosario, Argentina, 2000
    - Boehringer Ingelheim Investigational Site
Australia
- Queensland
  - Cotton Tree, Queensland, Australia, 4558
    - Boehringer Ingelheim Investigational Site
- Victoria
  - Malvern, Victoria, Australia, 3144
    - Emeritus Research
- Western Australia
  - Perth, Western Australia, Australia, 6004
    - Department of Rheumatology
Belgium
- - Bruxelles, Belgium, 1040
    - Clinique du Parc Leopold
  - Leuven, Belgium, 3000
    - Medisch Centrum van Huisartsen
Brazil
- - Goiânia GO, Brazil, 74043-011
    - Av Anhanguera 6479
  - Porto Alegre RS, Brazil, 90035-003
    - Rua Ramiro Barcelos 2350
  - São Paulo - SP, Brazil, 04040-000
    - Boehringer Ingelheim Investigational Site
  - São Paulo - SP, Brazil, 04230-000
    - Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
Canada
- British Columbia
  - Richmond, British Columbia, Canada, V7C 5L9
    - 230-6091
  - Victoria, British Columbia, Canada, V8P 5P6
    - Boehringer Ingelheim Investigational Site
- Ontario
  - Corunna, Ontario, Canada, N0N 1G0
    - Boehringer Ingelheim Investigational Site
  - Fort Erie, Ontario, Canada, L2A 1Z3
    - Boehringer Ingelheim Investigational Site
  - Hamilton, Ontario, Canada, L8N 1Y2
    - Boehringer Ingelheim Investigational Site
  - Kingston, Ontario, Canada, K7L 2V6
    - Dr. Denis O'Donnell
  - Mississauga, Ontario, Canada, L5B 4A2
    - Trillium Health Centre
  - Ottawa, Ontario, Canada, K2P 1V3
    - Boehringer Ingelheim Investigational Site
  - Peterborough, Ontario, Canada, K9J 7H8
    - Boehringer Ingelheim Investigational Site
  - Sarnia, Ontario, Canada, N7T 4X3
    - Boehringer Ingelheim Investigational Site
  - Scarborough, Ontario, Canada, M1B 4Y9
    - Boehringer Ingelheim Investigational Site
  - St. Catharines, Ontario, Canada, L2N 4H4
    - 104-532
  - Toronto, Ontario, Canada, M3B 2H9
    - Boehringer Ingelheim Investigational Site
  - Windsor, Ontario, Canada, N8W 5L7
    - Boehringer Ingelheim Investigational Site
- Quebec
  - Montreal, Quebec, Canada, H3G 1A4
    - Boehringer Ingelheim Investigational Site
  - Montreal, Quebec, Canada, H3Z, 2Z3
    - Boehringer Ingelheim Investigational Site
  - Pointe-Claire, Quebec, Canada, H9R 3J1
    - Boehringer Ingelheim Investigational Site
France
- - Marseille, France, 13008
    - Boehringer Ingelheim Investigational Site
  - Nice, France, 06000
    - Boehringer Ingelheim Investigational Site
  - Tours, France, 37000
    - Boehringer Ingelheim Investigational Site
  - Tours cedex 9, France, 37044
    - Boehringer Ingelheim Investigational Site
Germany
- - Aachen, Germany, 52064
    - Boehringer Ingelheim Investigational Site
  - Bad Kreuznach, Germany, 55543
    - Augusta-Klinik
  - Bad Segeberg, Germany, 23795
    - Boehringer Ingelheim Investigational Site
  - Berlin, Germany, 14059
    - Rheumatologie und Physikalische Therapie
  - Ellefeld, Germany, 08236
    - Boehringer Ingelheim Investigational Site
  - Essen, Germany, 45356
    - Elisabeth-Krankenhaus
  - Klotten, Germany, 56818
    - Boehringer Ingelheim Investigational Site
  - Leipzig, Germany, 04229
    - ClinPharm International GmbH & Co. KG
  - München, Germany, 81541
    - Boehringer Ingelheim Investigational Site
  - Nürnberg, Germany, 90461
    - Boehringer Ingelheim Investigational Site
  - Nürnberg, Germany, 90402
    - Boehringer Ingelheim Investigational Site
  - Steinhöring, Germany, 85643
    - Boehringer Ingelheim Investigational Site
  - Tübingen, Germany, 72070
    - Boehringer Ingelheim Investigational Site
  - Wiesbaden, Germany, 65191
    - Klinik für Rheumatologie,
Hungary
- - Budapest, Hungary, 1027
    - National Institute for Rheumatology and Physiotherapy
  - Debrecen, Hungary, 4031
    - DOTE
  - Györ, Hungary, 9024
    - Aladár Petz County Hospital
  - Hévíz, Hungary, 8380
    - St. Andrew State Hospital
  - Miskolc, Hungary, 3501
    - St. Ferenc Hospital
  - Pecs, Hungary, 7621
    - Hungarian Brothers of St. John of Good
  - Szeged, Hungary, 6720
    - Szegedi University
  - Veszprem, Hungary, 8201
    - Ferenc Csolnoky County Hospital
  - Ózd, Hungary, 3601
    - Pál Almási Balogh Hospital
Italy
- - Genova, Italy
    - Università degli Studi
  - Jesi, Italy, 60035
    - Ospedale Augusto Murri
  - Napoli, Italy, 80131
    - Università degli Studi di Napoli "Federico II"
  - SAN CESARIO (Lecce), Italy, 73016
    - Ospedale A. Galateo
Korea, Republic of
- - Gyeonggi-Do, Korea, Republic of, 431-070
    - 896 Pyung Chon-Dong, Dongan-Gu
  - Gyeonggi-Do, Korea, Republic of, 442-721
    - San-5, Woncheon-Dong, Paldal-Gu
  - Seoul, Korea, Republic of, 110-744
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 100-032
    - 85 Jeo-Dong 2Ga
  - Seoul, Korea, Republic of, 120-752
    - Boehringer Ingelheim Investigational Site
Russian Federation
- - Moscow, Russian Federation, 115522
    - Institute of Rheumatology of RAMN
  - Moscow, Russian Federation, 117049
    - City Clinical Hospital No. 1
Taiwan
- - Kaohsiung, Taiwan
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Kaohsiung, Taiwan
    - Rheumatology-Allergy-Immunology
  - Taipei, Taiwan
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 105
    - Chang Gung Memorial Hospital
Ukraine
- - Dnyepropetrovsk, Ukraine, 49044
    - Dnyepropyetrovsk Medical Academy
  - Donetsk, Ukraine, 83098
    - Central City Hospital
  - Donetsk, Ukraine, 83114
    - State Medical University
  - Kharkov, Ukraine, 61091
    - Municipal Institute of Health Care
  - Kharkov, Ukraine, 61115
    - City Multitype Clinical Hospital No. 25
  - Kiev, Ukraine, 03151
    - Institute of Cardiology
  - Kiev, Ukraine, 01023
    - Central Clinical Hospital
  - Kiev, Ukraine, 04107
    - Regional Hospital No. 1
  - Kyiv, Ukraine, 04114
    - Institute of Gerontology
United States
- Alabama
  - Huntsville, Alabama, United States, 35801
    - Suites 570 (research) & 600 (PI)
  - Montgomery, Alabama, United States, 36106
    - Suite 200
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Suite 140
- Arizona
  - Glendale, Arizona, United States, 85308
    - #106
  - Phoenix, Arizona, United States, 85012
    - Suite 601
  - Phoenix, Arizona, United States, 85015
    - Suite 201
- California
  - Los Angeles, California, United States, 90048
    - Boehringer Ingelheim Investigational Site
  - Pasadena, California, United States, 91105
    - Boehringer Ingelheim Investigational Site
  - Rancho Cucamonga, California, United States, 91730
    - Suite 100
  - Rancho Mirage, California, United States, 92270-4469
    - Boehringer Ingelheim Investigational Site
  - San Diego, California, United States, 92108
    - Suite 208
  - San Diego, California, United States, 92120
    - Suite 202
  - San Leandro, California, United States, 94578
    - Suite 301
  - Santa Maria, California, United States, 93454
    - Suite A
  - Westlake Village, California, United States, 91361
    - Westlake Medical Research
- Colorado
  - Colorado Springs, Colorado, United States, 80910
    - Suite 200
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Suites 205 & 206
- District of Columbia
  - Washington, District of Columbia, United States, 20006
    - Suite 300
- Florida
  - Del Ray Beach, Florida, United States, 33484
    - Boehringer Ingelheim Investigational Site
  - Gainsville, Florida, United States, 32607
    - Boehringer Ingelheim Investigational Site
  - Jacksonville, Florida, United States, 32204
    - Boehringer Ingelheim Investigational Site
  - Largo, Florida, United States, 33773
    - Boehringer Ingelheim Investigational Site
  - Miami, Florida, United States, 33173
    - Suite 202
  - Ocala, Florida, United States, 34471
    - Renstar Medical Research
  - Ocala, Florida, United States, 03474
    - Boehringer Ingelheim Investigational Site
  - Orlando, Florida, United States, 32804
    - Boehringer Ingelheim Investigational Site
  - Orlando, Florida, United States, 32806
    - Suite 2
  - Safety Harbor, Florida, United States, 34695
    - Suite 406
  - Sarasota, Florida, United States, 34239
    - Boehringer Ingelheim Investigational Site
  - South Miami, Florida, United States, 33143
    - Boehringer Ingelheim Investigational Site
  - St. Petersburg, Florida, United States, 33710
    - Suite 101
  - Stuart, Florida, United States, 34996
    - Radiant Research
  - Tampa, Florida, United States, 33614
    - Suite 203
  - Zephyrhills, Florida, United States, 33540
    - Boehringer Ingelheim Investigational Site
- Idaho
  - Coeur d'Alene, Idaho, United States, 83814-2644
    - Boehringer Ingelheim Investigational Site
  - Idaho Falls, Idaho, United States, 83404
    - Suite 202
- Illinois
  - Lake Forest, Illinois, United States, 60045
    - Boehringer Ingelheim Investigational Site
  - Rockford, Illinois, United States, 61103
    - Boehringer Ingelheim Investigational Site
  - Springfield, Illinois, United States, 62704
    - Boehringer Ingelheim Investigational Site
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Boehringer Ingelheim Investigational Site
- Kansas
  - Wichita, Kansas, United States, 67207
    - Attn: Kathy Stoddard, Director
- Maryland
  - Wheaton, Maryland, United States, 20902
    - Suite 306
- Massachusetts
  - Fall River, Massachusetts, United States, 02720
    - Truesdale Clinic
- Michigan
  - Kalamazoo, Michigan, United States, 49009
    - Suite 202
- Missouri
  - St. Louis, Missouri, United States, 63128
    - Suite 101
  - St. Louis, Missouri, United States, 63141
    - Suite 240
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Boehringer Ingelheim Investigational Site
- Nevada
  - Reno, Nevada, United States, 89502-1196
    - Boehringer Ingelheim Investigational Site
- New Jersey
  - Medford, New Jersey, United States, 08055
    - PC, Jackson Commons D-2
  - Mercerville, New Jersey, United States, 08619
    - Suite 8
- New York
  - New York, New York, United States, 10021
    - Boehringer Ingelheim Investigational Site
- North Carolina
  - Charlotte, North Carolina, United States, 28210
    - Suite 100
- Ohio
  - Columbus, Ohio, United States, 43214
    - Boehringer Ingelheim Investigational Site
- Oklahoma
  - Tulsa, Oklahoma, United States, 74135
    - Boehringer Ingelheim Investigational Site
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - Boehringer Ingelheim Investigational Site
  - Duncansville, Pennsylvania, United States, 16635
    - Altoona Center for Clinical Research
  - Erie, Pennsylvania, United States, 16508-1256
    - Boehringer Ingelheim Investigational Site
  - Mechanicsburg, Pennsylvania, United States, 17055
    - Suite D
- Rhode Island
  - Johnston, Rhode Island, United States, 02919
    - Suite 331-333
- South Carolina
  - Columbia, South Carolina, United States, 29204
    - Boehringer Ingelheim Investigational Site
  - North Charleston, South Carolina, United States, 29406
    - Suite H
  - Orangeburg, South Carolina, United States, 29118
    - Boehringer Ingelheim Investigational Site
- Texas
  - Austin, Texas, United States, 78705
    - Boehringer Ingelheim Investigational Site
  - Dallas, Texas, United States, 75231
    - Radiant Research
  - Dallas, Texas, United States, 75225
    - Boehringer Ingelheim Investigational Site
  - Dallas, Texas, United States, 75246-1632
    - Suite 200
  - Lubbock, Texas, United States, 79410
    - Suite 500
  - San Antonio, Texas, United States, 78217
    - Suites 207
- Virginia
  - Falls Church, Virginia, United States, 22044
    - Suite 2A
- Washington
  - Everett, Washington, United States, 98201
    - Boehringer Ingelheim Investigational Site
  - Seattle, Washington, United States, 98166-2967
    - Suite D-3
  - Yakima, Washington, United States, 98902
    - Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response according to American College of Rheumatology 20% (ACR20) classification Time Frame: at 12 weeks	at 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of painful or tender joints Time Frame: up to 12 weeks	up to 12 weeks
Number of swollen joints Time Frame: up to 12 weeks	up to 12 weeks
Patient's global (overall) assessment of disease activity Time Frame: up to 12 weeks	up to 12 weeks
Investigator's global (overall) assessment of disease activity Time Frame: up to 12 weeks	up to 12 weeks
Patient's assessment of pain Time Frame: up to 12 weeks	up to 12 weeks
Patient's assessment of physical function (mHAQ) Time Frame: up to 12 weeks	up to 12 weeks
C-Reactive Protein (CRP) Time Frame: up to 12 weeks	up to 12 weeks
Withdrawal due to lack of efficacy Time Frame: up to 12 weeks	up to 12 weeks
Duration of morning stiffness Time Frame: up to of 12 weeks	up to of 12 weeks
Patient's final global (overall) assessment of efficacy Time Frame: at end of 12 weeks	at end of 12 weeks
Investigator's final global (overall) assessment of efficacy Time Frame: at end of 12 weeks	at end of 12 weeks
Patient status with regard to change in arthritic condition Time Frame: at end of 12 weeks	at end of 12 weeks
Use of rescue medication Time Frame: up to 12 weeks	up to 12 weeks
Incidence and intensity of adverse events Time Frame: until 4 weeks post treatment	until 4 weeks post treatment
Patient's final global assessment of tolerability Time Frame: at end of 12 weeks	at end of 12 weeks
Investigator's final global assessment of tolerability Time Frame: at end of 12 weeks	at end of 12 weeks
Withdrawals due to adverse events Time Frame: at end of 12 weeks	at end of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim Ltd./Bracknell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion

July 1, 2003

Study Registration Dates

First Submitted

July 22, 2002

First Submitted That Met QC Criteria

July 23, 2002

First Posted (Estimate)

July 24, 2002

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

107.258

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.