Clinical trial NCT00042068: A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2002-07-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Response according to American College of Rheumatology 20% (ACR20) classification
timeFrame: at 12 weeks
Secondary outcomes:
measure: Number of painful or tender joints
timeFrame: up to 12 weeks
measure: Number of swollen joints
timeFrame: up to 12 weeks
measure: Patient's global (overall) assessment of disease activity
timeFrame: up to 12 weeks
measure: Investigator's global (overall) assessment of disease activity
timeFrame: up to 12 weeks
measure: Patient's assessment of pain
timeFrame: up to 12 weeks
measure: Patient's assessment of physical function (mHAQ)
timeFrame: up to 12 weeks
measure: C-Reactive Protein (CRP)
timeFrame: up to 12 weeks
measure: Withdrawal due to lack of efficacy
timeFrame: up to 12 weeks
measure: Duration of morning stiffness
timeFrame: up to of 12 weeks
measure: Patient's final global (overall) assessment of efficacy
timeFrame: at end of 12 weeks
measure: Investigator's final global (overall) assessment of efficacy
timeFrame: at end of 12 weeks
measure: Patient status with regard to change in arthritic condition
timeFrame: at end of 12 weeks
measure: Use of rescue medication
timeFrame: up to 12 weeks
measure: Incidence and intensity of adverse events
timeFrame: until 4 weeks post treatment
measure: Patient's final global assessment of tolerability
timeFrame: at end of 12 weeks
measure: Investigator's final global assessment of tolerability
timeFrame: at end of 12 weeks
measure: Withdrawals due to adverse events
timeFrame: at end of 12 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Suites 570 (research) & 600 (PI)
state: Alabama
city: Montgomery
country: United States
facility: Suite 200
state: Alabama
city: Anchorage
country: United States
facility: Suite 140
state: Alaska
city: Glendale
country: United States
facility: #106
state: Arizona
city: Phoenix
country: United States
facility: Suite 601
state: Arizona
city: Phoenix
country: United States
facility: Suite 201
state: Arizona
city: Los Angeles
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Pasadena
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Rancho Cucamonga
country: United States
facility: Suite 100
state: California
city: Rancho Mirage
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: Suite 208
state: California
city: San Diego
country: United States
facility: Suite 202
state: California
city: San Leandro
country: United States
facility: Suite 301
state: California
city: Santa Maria
country: United States
facility: Suite A
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Colorado Springs
country: United States
facility: Suite 200
state: Colorado
city: Danbury
country: United States
facility: Suites 205 & 206
state: Connecticut
city: Washington
country: United States
facility: Suite 300
state: District of Columbia
city: Del Ray Beach
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Gainsville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Largo
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: Suite 202
state: Florida
city: Ocala
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: Suite 2
state: Florida
city: Safety Harbor
country: United States
facility: Suite 406
state: Florida
city: Sarasota
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: South Miami
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Suite 101
state: Florida
city: Stuart
country: United States
facility: Radiant Research
state: Florida
city: Tampa
country: United States
facility: Suite 203
state: Florida
city: Zephyrhills
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Idaho
city: Idaho Falls
country: United States
facility: Suite 202
state: Idaho
city: Lake Forest
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: Rockford
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Attn: Kathy Stoddard, Director
state: Kansas
city: Wheaton
country: United States
facility: Suite 306
state: Maryland
city: Fall River
country: United States
facility: Truesdale Clinic
state: Massachusetts
city: Kalamazoo
country: United States
facility: Suite 202
state: Michigan
city: St. Louis
country: United States
facility: Suite 101
state: Missouri
city: St. Louis
country: United States
facility: Suite 240
state: Missouri
city: Lincoln
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Nebraska
city: Reno
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Nevada
city: Medford
country: United States
facility: PC, Jackson Commons D-2
state: New Jersey
city: Mercerville
country: United States
facility: Suite 8
state: New Jersey
city: New York
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Charlotte
country: United States
facility: Suite 100
state: North Carolina
city: Columbus
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Camp Hill
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Erie
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Suite D
state: Pennsylvania
city: Johnston
country: United States
facility: Suite 331-333
state: Rhode Island
city: Columbia
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: North Charleston
country: United States
facility: Suite H
state: South Carolina
city: Orangeburg
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Dallas
country: United States
facility: Suite 200
state: Texas
city: Lubbock
country: United States
facility: Suite 500
state: Texas
city: San Antonio
country: United States
facility: Suites 207
state: Texas
city: Falls Church
country: United States
facility: Suite 2A
state: Virginia
city: Everett
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
city: Seattle
country: United States
facility: Suite D-3
state: Washington
city: Yakima
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Boehringer Ingelheim Investigational Site
city: Buenos Aires
country: Argentina
facility: Boehringer Ingelheim Investigational Site
city: Buenos Aires
country: Argentina
facility: Boehringer Ingelheim Investigational Site
city: Rosario
country: Argentina
facility: Boehringer Ingelheim Investigational Site
city: Cotton Tree
country: Australia
facility: Boehringer Ingelheim Investigational Site
state: Queensland
city: Malvern
country: Australia
facility: Emeritus Research
state: Victoria
city: Perth
country: Australia
facility: Department of Rheumatology
state: Western Australia
city: Bruxelles
country: Belgium
facility: Clinique du Parc Léopold
city: Leuven
country: Belgium
facility: Medisch Centrum van Huisartsen
city: Goiânia GO
country: Brazil
facility: Av Anhanguera 6479
city: Porto Alegre RS
country: Brazil
facility: Rua Ramiro Barcelos 2350
city: São Paulo - SP
country: Brazil
facility: Boehringer Ingelheim Investigational Site
city: São Paulo - SP
country: Brazil
facility: Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
city: Richmond
country: Canada
facility: 230-6091
state: British Columbia
city: Victoria
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: British Columbia
city: Corunna
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Fort Erie
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Dr. Denis O'Donnell
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: St. Catharines
country: Canada
facility: 104-532
state: Ontario
city: Toronto
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
city: Marseille
country: France
facility: Boehringer Ingelheim Investigational Site
city: Nice
country: France
facility: Boehringer Ingelheim Investigational Site
city: Tours cedex 9
country: France
facility: Boehringer Ingelheim Investigational Site
city: Tours
country: France
facility: Boehringer Ingelheim Investigational Site
city: Aachen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Bad Kreuznach
country: Germany
facility: Augusta-Klinik
city: Bad Segeberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Rheumatologie und Physikalische Therapie
city: Ellefeld
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus
city: Klotten
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: ClinPharm International GmbH & Co. KG
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Steinhöring
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Tübingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: Klinik für Rheumatologie,
city: Budapest
country: Hungary
facility: National Institute for Rheumatology and Physiotherapy
city: Debrecen
country: Hungary
facility: DOTE
city: Györ
country: Hungary
facility: Aladár Petz County Hospital
city: Hévíz
country: Hungary
facility: St. Andrew State Hospital
city: Miskolc
country: Hungary
facility: St. Ferenc Hospital
city: Pecs
country: Hungary
facility: Hungarian Brothers of St. John of Good
city: Szeged
country: Hungary
facility: Szegedi University
city: Veszprem
country: Hungary
facility: Ferenc Csolnoky County Hospital
city: Ózd
country: Hungary
facility: Pál Almási Balogh Hospital
city: Genova
country: Italy
facility: Università degli Studi
city: Jesi
country: Italy
facility: Ospedale Augusto Murri
city: Napoli
country: Italy
facility: Università degli Studi di Napoli "Federico II"
city: SAN CESARIO (Lecce)
country: Italy
facility: Ospedale A. Galateo
city: Gyeonggi-Do
country: Korea, Republic of
facility: 896 Pyung Chon-Dong, Dongan-Gu
city: Gyeonggi-Do
country: Korea, Republic of
facility: San-5, Woncheon-Dong, Paldal-Gu
city: Seoul
country: Korea, Republic of
facility: 85 Jeo-Dong 2Ga
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Institute of Rheumatology of RAMN
city: Moscow
country: Russian Federation
facility: City Clinical Hospital No. 1
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Rheumatology-Allergy-Immunology
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Dnyepropetrovsk
country: Ukraine
facility: Dnyepropyetrovsk Medical Academy
city: Donetsk
country: Ukraine
facility: Central City Hospital
city: Donetsk
country: Ukraine
facility: State Medical University
city: Kharkov
country: Ukraine
facility: Municipal Institute of Health Care
city: Kharkov
country: Ukraine
facility: City Multitype Clinical Hospital No. 25
city: Kiev
country: Ukraine
facility: Central Clinical Hospital
city: Kiev
country: Ukraine
facility: Institute of Cardiology
city: Kiev
country: Ukraine
facility: Regional Hospital No. 1
city: Kyiv
country: Ukraine
facility: Institute of Gerontology
Study officials:
affiliation: Boehringer Ingelheim Ltd./Bracknell
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: