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.

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: Meloxicam	Phase III

Further Study Details: 

The primary aim of this trial is to compare the efficacy and safety of several doses of meloxicam (7.5 mg, 15 mg, and 22.5 mg) administered once daily with placebo over a period of 12 weeks in treatment of patients with RA. There will be 700 US patients enrolled and 500 US patients entered in 65-70 US sites.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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.

Alabama
      Rheumatology Assoc. of North Alabama, Huntsville,  Alabama,  35801,  United States
Alaska
      Advanced Clinical Therapeutics, LLC (ACT), Anchorage,  Alaska,  99508,  United States
Arizona
      Phoenix Center for Clinical Research, Phoenix,  Arizona,  85015,  United States
      Sun Valley Arthritis Center, Ltd., Glendale,  Arizona,  85308,  United States
California
      Westlake Medical Research, Inc., Westlake Village,  California,  91361,  United States
      The Wallace Rheumatic Study Center, Los Angeles,  California,  90048,  United States
      San Diego Arthritis & Osteoporosis Medical Clinic, San Diego,  California,  92120,  United States
      Pacific Arthritis Center Medical Group, Santa Maria,  California,  93454,  United States
      Irene Tong, M.D., Pasadena,  California,  91105,  United States
      Boling Clinical Trials, Rancho Cucamonga,  California,  91730,  United States
      East Bay Rheumatology Medical Group, San Leandro,  California,  94578,  United States
      Advances in Medicine, Rancho Mirage,  California,  92270,  United States
      Radiant Research, San Diego,  California,  92108,  United States
Colorado
      Arthritis Associates of Colorado Springs, Colorado Springs,  Colorado,  80910,  United States
Connecticut
      Clinical Research Center of CT/NY, Danbury,  Connecticut,  06810,  United States
District of Columbia
      The Center for Rheumatology and Bone Research, Washington,  District of Columbia,  20006,  United States
Florida
      Sarasota Arthritis Center, Sarasota,  Florida,  34239,  United States
      Arthritis Associates Inc., Orlando,  Florida,  32804,  United States
      Miami Research Associates, Miami,  Florida,  33173,  United States
      NTouch Research, St. Petersburg,  Florida,  33710,  United States
      Rheumatology Associates of Central Florida, Orlando,  Florida,  32806,  United States
      Clinical Research of Tampa Bay, Safety Harbor,  Florida,  34695,  United States
      The Center for Arthritis and Rheumatic Disease, South Miami,  Florida,  33143,  United States
      Renstar Medical Research, Ocala,  Florida,  34471,  United States
      Florida Medical Research Institute PA, Gainesville,  Florida,  32607,  United States
      Miami Research Associates, Miami,  Florida,  33173,  United States
      Tampa Medical Group Research, Tampa,  Florida,  33614,  United States
      Radiant Research, Stuart,  Florida,  34996,  United States
      Arthritis and Rehab Center of Jacksonville, Inc., Jacksonville,  Florida,  32204,  United States
      DMI Health Care, Largo,  Florida,  33773,  United States
      Florida Medical Clinic, PA Clinical Research Division, Zephyrhills,  Florida,  33540,  United States
      Stephen Bookbinder, M.D., Ocala,  Florida,  03474,  United States
      Arthritis Associates Clinical Research of So. Florida, Delray Beach,  Florida,  33484,  United States
      SW Florida Clinical Research Center, Tampa,  Florida,  33609,  United States
Idaho
      Institute of Arthritis Research, Idaho Falls,  Idaho,  83404,  United States
      Coeur d'Alene Arthritis Clinical Trials, Coeur D Alene,  Idaho,  83814,  United States
Illinois
      North Shore Rheumatology, Lake Forest,  Illinois,  60045,  United States
      NCCR, Chicago,  Illinois,  60611,  United States
      The Arthritis Center, Springfield,  Illinois,  62704,  United States
      Rockford Clinic, Rockford,  Illinois,  60045,  United States
Indiana
      Indiana University Medical Center, Dept. of Medicine, Indianapolis,  Indiana,  46202,  United States
Kansas
      Heartland Research Associates, LLC, Wichita,  Kansas,  67207,  United States
Maryland
      The Center for Rheumatology and Bone Research, Wheaton,  Maryland,  20902,  United States
Massachusetts
      Phase III Clinical Research, Fall River,  Massachusetts,  02720,  United States
Michigan
      Rheumatology, PC, Kalamazoo,  Michigan,  49009,  United States
Missouri
      Arthritis Consultants, Inc., St. Louis,  Missouri,  63141,  United States
      St. Louis Center for Clinical Research, St. Louis,  Missouri,  63141,  United States
Nebraska
      Arthritis Center of Nebraska, Lincoln,  Nebraska,  68506,  United States
Nevada
      Arthritis Center of Reno, Reno,  Nevada,  89502,  United States
New Jersey
      Arthritis Regional Research Center, Mercerville,  New Jersey,  08619,  United States
      Rheumatology and Arthritis Associates, Medford,  New Jersey,  08055,  United States
New York
      Hospital for Special Surgery, New York,  New York,  10021,  United States
North Carolina
      The Arthritis and Osteoporosis Center, Orangeburg,  North Carolina,  29118,  United States
Ohio
      Wendt Bristol Research Center, Columbus,  Ohio,  43214,  United States
Oklahoma
      Healthcard Research Consultants, Tulsa,  Oklahoma,  74135,  United States
Pennsylvania
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States
      C.a.R.E, Erie,  Pennsylvania,  16508,  United States
      Central Pennsylvania Clinical Research, Mechanicsburg,  Pennsylvania,  17055,  United States
      Internal Medicine, Camp Hill,  Pennsylvania,  17011,  United States
Rhode Island
      Scott Toder, MD, Johnston,  Rhode Island,  02919,  United States
South Carolina
      Low Country Research, North Charleston,  South Carolina,  29406,  United States
      Columbia Arthritis Center, Columbia,  South Carolina,  29204,  United States
Texas
      Walter F. Chase, M.D. PA, Austin,  Texas,  78705,  United States
      Arthritis Center of Texas, Dallas,  Texas,  75246-1632,  United States
      San Antonio Center for Clinical Research, San Antonio,  Texas,  78217,  United States
      Radiant Research Dallas, Dallas,  Texas,  75235,  United States
      Alan Brodsky, M.D., Dallas,  Texas,  75225,  United States
      Arthritis and Osteoporosis Assoc., Lubbock,  Texas,  79410,  United States
Virginia
      Metropolitan Clinical Research, Falls Church,  Virginia,  22044,  United States
Washington
      Arthritis Northwest, Seattle,  Washington,  98166,  United States
      Physician's Pharmaceutical Study Services, Everett,  Washington,  98201,  United States
      Clinical Trials, N.W., Yakima,  Washington,  98902,  United States

Study ID Numbers:  BI 107.258
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  July 22, 2002
ClinicalTrials.gov Identifier:  NCT00042068
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08