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3 Different Dose Levels of CCI-779 in Subjects with Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

This study is no longer recruiting patients.

Sponsored by: Wyeth-Ayerst Research
Information provided by: Wyeth-Ayerst Research

Purpose

The primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.

Condition Treatment or Intervention Phase
Rheumatoid Arthritis
 Drug: CCI-779
Phase II

MedlinePlus related topics:  Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects with Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria


Location Information


Alabama
      The University of Alabama at Birmingham, Birmingham,  Alabama,  35294-7201,  United States

      Rheumatology Associates of North Alabama, Huntsville,  Alabama,  35801,  United States

Arizona
      Radiant Research-Scottsdale, Scottsdale,  Arizona,  85251,  United States

      Arizona Arthritis Research PLC, Paradise Valley,  Arizona,  85253,  United States

      Radiant Research - Phoenix, Phoenix,  Arizona,  85015,  United States

California
      Pacific Arthritis Center, Santa Maria,  California,  93454-6945,  United States

Colorado
      Arthritis Associates and Opeoporosis Center of Colorado Springs, Colorado Springs,  Colorado,  80910,  United States

      Denver Arthritis Clinic, Denver,  Colorado,  80220,  United States

Connecticut
      Arthritis Center of CT, Waterbury,  Connecticut,  06708,  United States

      Clinical Research Consultants, Trumbull,  Connecticut,  06611,  United States

Florida
      Arthritis Center, Palm Harbor,  Florida,  34684,  United States

      Rheumatoloy / Immunology Arthritis Center, Fort Lauderdale,  Florida,  33334,  United States

      Tampa Medical Group, Tampa,  Florida,  33614,  United States

      Renstar Medical Research, Ocala,  Florida,  34471-2106,  United States

      Artritis Associates of South Flordia, Delray Beach,  Florida,  33484,  United States

      Tampa Bay Medical Research, Inc., Clearwater,  Florida,  34621,  United States

      Sarasota Arthritis Research Center, Sarasota,  Florida,  34239,  United States

      Research Site, Orlando,  Florida,  32804,  United States

Idaho
      Institute of Arthritis and Research, Idaho Falls,  Idaho,  83404,  United States

Illinois
      Rheumatology Rockford Clinic, Rockford,  Illinois,  61103,  United States

Indiana
      Rheumatology Indiana University, Indianapolis,  Indiana,  46202-5103,  United States

Kansas
      Wichita Clinic, Wichita,  Kansas,  67208,  United States

Maryland
      Arthritis and Osteporosis Center of Maryland, Frederick,  Maryland,  21702,  United States

Massachusetts
      Rheumatology Dept. Beth Israel, Boston,  Massachusetts,  02215,  United States

      Phase III Clinical Research, Fall River,  Massachusetts,  02720,  United States

Michigan
      Midwest Arthritis Center, Kalamazoo,  Michigan,  49001-1634,  United States

      Division of Rheumatology/Internal Medicine, Ann Arbor,  Michigan,  48109-0358,  United States

Missouri
      St. Louis Center for Clinical Research, St. Louis,  Missouri,  63128,  United States

      St. Louis University Solutions, St. Louis,  Missouri,  63104,  United States

New Jersey
      Arthritis, Rheumatic and Back, Vorhees,  New Jersey,  08043,  United States

New York
      Hospital for Joint Disease, New York,  New York,  10003,  United States

      Research Site, Mamaroneck,  New York,  10543,  United States

      New Jersey Physicians, LLC, Passaic,  New York,  07055,  United States

      North Shore University Hospital, Manhasset,  New York,  11030,  United States

North Carolina
      Arthritis Clinic Carolina Bone, Charlotte,  North Carolina,  28210,  United States

Ohio
      Research Site, Mayfield Village,  Ohio,  44143,  United States

Oklahoma
      Lynn Health Science Institute, Oklahoma City,  Oklahoma,  73112,  United States

Pennsylvania
      Rheumatic Disease Associates, Willow Grove,  Pennsylvania,  19090,  United States

      Research Site, Philadelphia,  Pennsylvania,  19104,  United States

      Altoona Center for Clinical Research, Ducansville,  Pennsylvania,  16635,  United States

South Carolina
      Low Country Rheumatology, Charleston,  South Carolina,  29406,  United States

Tennessee
      Vanderbilt University Medical, Nashville,  Tennessee,  37203-1424,  United States

Texas
      Arthritis Care and Diagnostic, Dallas,  Texas,  75231,  United States

      Arthritis Center of Texas, Dallas,  Texas,  75246,  United States

      Radiant Research, San Antonio,  Texas,  75231,  United States

Utah
      Physicians' Research Options, LLC, Ogden,  Utah,  84043,  United States

Washington
      Physicians Clinic of Spokane, Spokane,  Washington,  99204,  United States

      Arthritis Northwest, Seattle,  Washington,  98166-2967,  United States

      Olympia Arthritis Center, Olympia,  Washington,  98502,  United States

West Virginia
      West Virginia University, Morgantown,  West Virginia,  26506-9162,  United States

Wisconsin
      Gundersen Clinic, La Crosse,  Wisconsin,  54601,  United States

      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53266,  United States

More Information

Study ID Numbers:  3066A3-206-WW
Record last reviewed:  October 2004
Record first received:  January 15, 2004
ClinicalTrials.gov Identifier:  NCT00076206
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-22
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