A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- Registration Number
- NCT00042068
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Response according to American College of Rheumatology 20% (ACR20) classification at 12 weeks
- Secondary Outcome Measures
Name Time Method Withdrawal due to lack of efficacy up to 12 weeks Number of painful or tender joints up to 12 weeks Number of swollen joints up to 12 weeks Patient's global (overall) assessment of disease activity up to 12 weeks Investigator's global (overall) assessment of disease activity up to 12 weeks Patient's assessment of pain up to 12 weeks Patient's assessment of physical function (mHAQ) up to 12 weeks Use of rescue medication up to 12 weeks Patient's final global assessment of tolerability at end of 12 weeks Patient's final global (overall) assessment of efficacy at end of 12 weeks Incidence and intensity of adverse events until 4 weeks post treatment Withdrawals due to adverse events at end of 12 weeks C-Reactive Protein (CRP) up to 12 weeks Duration of morning stiffness up to of 12 weeks Investigator's final global (overall) assessment of efficacy at end of 12 weeks Patient status with regard to change in arthritic condition at end of 12 weeks Investigator's final global assessment of tolerability at end of 12 weeks
Trial Locations
- Locations (83)
Suite 202
🇺🇸Kalamazoo, Michigan, United States
Suite 140
🇺🇸Anchorage, Alaska, United States
Suite 200
🇺🇸Dallas, Texas, United States
Suites 570 (research) & 600 (PI)
🇺🇸Huntsville, Alabama, United States
Suite 101
🇺🇸St. Louis, Missouri, United States
Suite 240
🇺🇸St. Louis, Missouri, United States
Clinique du Parc Léopold
🇧🇪Bruxelles, Belgium
Emeritus Research
🇦🇺Malvern, Victoria, Australia
Aladár Petz County Hospital
🇭🇺Györ, Hungary
#106
🇺🇸Glendale, Arizona, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Suite D
🇺🇸Mechanicsburg, Pennsylvania, United States
St. Ferenc Hospital
🇭🇺Miskolc, Hungary
Suite 100
🇺🇸Charlotte, North Carolina, United States
Suite 2
🇺🇸Orlando, Florida, United States
Suite A
🇺🇸Santa Maria, California, United States
Suite 406
🇺🇸Safety Harbor, Florida, United States
Truesdale Clinic
🇺🇸Fall River, Massachusetts, United States
Attn: Kathy Stoddard, Director
🇺🇸Wichita, Kansas, United States
Dr. Denis O'Donnell
🇨🇦Kingston, Ontario, Canada
Suite 331-333
🇺🇸Johnston, Rhode Island, United States
Pál Almási Balogh Hospital
🇭🇺Ózd, Hungary
Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
Central City Hospital
🇺🇦Donetsk, Ukraine
Suite 203
🇺🇸Tampa, Florida, United States
Hungarian Brothers of St. John of Good
🇭🇺Pecs, Hungary
Westlake Medical Research
🇺🇸Westlake Village, California, United States
Suite 300
🇺🇸Washington, District of Columbia, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
104-532
🇨🇦St. Catharines, Ontario, Canada
Klinik für Rheumatologie,
🇩🇪Wiesbaden, Germany
Suite H
🇺🇸North Charleston, South Carolina, United States
Medisch Centrum van Huisartsen
🇧🇪Leuven, Belgium
Suite 306
🇺🇸Wheaton, Maryland, United States
Suite 8
🇺🇸Mercerville, New Jersey, United States
National Institute for Rheumatology and Physiotherapy
🇭🇺Budapest, Hungary
Suite 500
🇺🇸Lubbock, Texas, United States
Suite 2A
🇺🇸Falls Church, Virginia, United States
PC, Jackson Commons D-2
🇺🇸Medford, New Jersey, United States
Elisabeth-Krankenhaus
🇩🇪Essen, Germany
St. Andrew State Hospital
🇭🇺Hévíz, Hungary
Ferenc Csolnoky County Hospital
🇭🇺Veszprem, Hungary
Dnyepropyetrovsk Medical Academy
🇺🇦Dnyepropetrovsk, Ukraine
Institute of Cardiology
🇺🇦Kiev, Ukraine
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Institute of Gerontology
🇺🇦Kyiv, Ukraine
Av Anhanguera 6479
🇧🇷Goiânia GO, Brazil
Rua Ramiro Barcelos 2350
🇧🇷Porto Alegre RS, Brazil
San-5, Woncheon-Dong, Paldal-Gu
🇰🇷Gyeonggi-Do, Korea, Republic of
DOTE
🇭🇺Debrecen, Hungary
Institute of Rheumatology of RAMN
🇷🇺Moscow, Russian Federation
Municipal Institute of Health Care
🇺🇦Kharkov, Ukraine
Central Clinical Hospital
🇺🇦Kiev, Ukraine
City Clinical Hospital No. 1
🇷🇺Moscow, Russian Federation
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
City Multitype Clinical Hospital No. 25
🇺🇦Kharkov, Ukraine
Regional Hospital No. 1
🇺🇦Kiev, Ukraine
State Medical University
🇺🇦Donetsk, Ukraine
Università degli Studi
🇮🇹Genova, Italy
Ospedale Augusto Murri
🇮🇹Jesi, Italy
Università degli Studi di Napoli "Federico II"
🇮🇹Napoli, Italy
Ospedale A. Galateo
🇮🇹SAN CESARIO (Lecce), Italy
Suites 207
🇺🇸San Antonio, Texas, United States
Suite 601
🇺🇸Phoenix, Arizona, United States
Suite 201
🇺🇸Phoenix, Arizona, United States
Suite D-3
🇺🇸Seattle, Washington, United States
Suite 208
🇺🇸San Diego, California, United States
Suite 301
🇺🇸San Leandro, California, United States
85 Jeo-Dong 2Ga
🇰🇷Seoul, Korea, Republic of
Szegedi University
🇭🇺Szeged, Hungary
Suites 205 & 206
🇺🇸Danbury, Connecticut, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
🇧🇷São Paulo - SP, Brazil
Augusta-Klinik
🇩🇪Bad Kreuznach, Germany
Rheumatologie und Physikalische Therapie
🇩🇪Berlin, Germany
ClinPharm International GmbH & Co. KG
🇩🇪Leipzig, Germany
896 Pyung Chon-Dong, Dongan-Gu
🇰🇷Gyeonggi-Do, Korea, Republic of
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
230-6091
🇨🇦Richmond, British Columbia, Canada
Rheumatology-Allergy-Immunology
🇨🇳Kaohsiung, Taiwan
Chang Gung Memorial Hospital
🇨🇳Taipei, Taiwan
Department of Rheumatology
🇦🇺Perth, Western Australia, Australia
Radiant Research
🇺🇸Dallas, Texas, United States