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3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on 3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy Clinical research trials and 3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like 3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy. 3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a 3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy clinical trial. Participants frequently obtain the most expert healthcare available for their 3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "3" Clinical Trials Conditions > 3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy 3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy
3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy
For Condition: Rheumatoid Arthritis
Status: No longer recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Meet American College of Rheumatology (ACR) criteria for RA. - Have active RA consisting of 6 swollen and 6 painful joints. - ACR functional class I-III. - Disease duration of at least 6 months. - Disease onset at age > 16 years of age. - Age 18 to 75 years. - Must be treated with MTX once weekly for at least 4 months prior to screening visit. - Must be currently treated with a stable, well-tolerated dose of MTX (7.5 to 20 mg) given once weekly for at least 8 weeks prior to screening visit. - Willing to remain on a constant, once weekly-dose of MTX throughout the study. - Understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed. - Have never participated in any CCI-779 clinical trial, nor have any prior exposure to CCI-779 or sirolimus. - Be able and willing to comply with study visits and procedures per protocol. - Women of childbearing potential must use a medically acceptable means of birth control in an effective manner and agree to continue its use during the study and for 12 weeks after the last dose of test article (TA) [CCI-779 or placebo]. - Sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after the last dose of TA. - Able to store TA in a refrigerator. - Subjects taking hydroxychloroquine must be on stable doses of 400 mg per day with monitoring as recommended in the product information. Exclusion Criteria - At screening the subject’s prior medications are reviewed. Prior history of disease-modifying antirheumatic drug (DMARD) use is recorded, including the start and stop dates of the most recently taken DMARDs. Subjects will be excluded if the use of certain medications or events occur within the designated time interval before the screening visit. - Significant concurrent medical diseases. - Abnormal chest radiograph, including findings consistent with interstitial pneumonitis, granulomatous disease, or pleural effusion and/or infiltration - Presence of significant active infection or any underlying diseases that could predispose the subject to infections (e.g., a history of recurring infections, nonhealing leg ulcers) - Current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent. - Any medical or surgical condition that might interfere with drug absorption, distribution, metabolism, or excretion - Presence or history of confirmed blood dyscrasias - Any clinically significant laboratory abnormality, in addition to those listed below (#9 to #13). - Leukopenia (white blood cells < 3.50 x 10^3/mm^3 [SI units: < 3.50 x 10^9/L]) - Thrombocytopenia or thrombocytosis (platelets < 125,000/mm^3 or 1,000,000/mm^3 [SI units: < 125 x 10^9/L or 1,000 x 10^9/L]), respectively - Liver function abnormality (total bilirubin > 1.5 x the upper limit of normal, aspartate aminotransferase [AST/ SGOT], alanine aminotransferase [ALT/SGPT]: > 1.2 x upper limit of normal) - Fasting serum low-density lipoprotein (LDL) cholesterol level 190 mg/dL (SI units: 4.91 mmol/L) - Fasting serum triglyceride levels > 200 mg/dL (SI units: > 2.26 mmol/L) - History of any clinically significant drug-induced liver injury at any time before screening - Any history of hepatitis C or hepatitis B viral infection. Presence of hepatitis B surface antigen (HBsAg), or hepatitis C antibody (hepatitis C Ab) as confirmed by hepatitis C radioimmunoblot assay (HCV-RIBA) - Any condition for which participation in this study is judged by the physician to be detrimental to the subject, such as history of a DMARD-related severe, potentially life-threatening adverse event (AE) - History of drug abuse - History of alcohol abuse or excessive alcoholic consumption (i.e., 3 or more alcohol-containing drinks per day) - Pregnant or breastfeeding women or planning to become pregnant during the study or within 12 weeks after the last dose of TA - Any major surgery, including joint surgery, within 3 months before screening visit - Scheduled elective surgery during study participation
Total Enrollment:
Location and Contact Information:
The University of Alabama at Birmingham
Birmingham, Alabama, 35294-7201
United States
Arthritis Associates and Opeoporosis Center of Colorado Springs
Colorado Springs, Colorado, 80910
United States
Radiant Research-Scottsdale
Scottsdale, Arizona, 85251
United States
Research Site
Mamaroneck, New York, 10543
United States
Arthritis Center of Texas
Dallas, Texas, 75246
United States
Institute of Arthritis and Research
Idaho Falls, Idaho, 83404
United States
Rheumatoloy / Immunology Arthritis Center
Ft. Lauderdale, Florida, 33334
United States
New Jersey Physicians, LLC
Passaic, New York, 07055
United States
Altoona Center for Clinical Research
Ducansville, Pennsylvania, 16635
United States
West Virginia University
Morgantown, West Virginia, 26506-9162
United States
Artritis Associates of South Flordia
Delray Beach, Florida, 33484
United States
Wichita Clinic
Wichita, Kansas, 67208
United States
Vanderbilt University Medical
Nashville, Tennessee, 37203-1424
United States
Arthritis Northwest
Seattle, Washington, 98166-2967
United States
Pacific Arthritis Center
Santa Maria, California, 93454-6945
United States
Rheumatology Dept. Beth Israel
Boston, Massachusetts, 02215
United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 34621
United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801
United States
Arizona Arthritis Research PLC
Paradise Valley, Arizona, 85253
United States
Arthritis Center
Palm Harbor, Florida, 34684
United States
Arthritis Center of CT
Waterbury, Connecticut, 06708
United States
Rheumatology Rockford Clinic
Rockford, Illinois, 61103
United States
Arthritis Care and Diagnostic
Dallas, Texas, 75231
United States
Denver Arthritis Clinic
Denver, Colorado, 80220
United States
Arthritis and Osteporosis Center of Maryland
Frederick, Maryland, 21702
United States
Renstar Medical Research
Ocala, Florida, 34471-2106
United States
Midwest Arthritis Center
Kalamazoo, Michigan, 49001-1634
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Rheumatology Indiana University
Indianapolis, Indiana, 46202-5103
United States
Clinical Research Consultants
Trumbull, Connecticut, 06611
United States
Research Site
Orlando, Florida, 32804
United States
Gundersen Clinic
La Crosse, Wisconsin, 54601
United States
Phase III Clinical Research
Fall River, Massachusetts, 02720
United States
Research Site
Mayfield Village, Ohio, 44143
United States
Physicians' Research Options, LLC
Ogden, Utah, 84043
United States
Olympia Arthritis Center
Olympia, Washington, 98502
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53266
United States
Radiant Research - Phoenix
Phoenix, Arizona, 85015
United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Arthritis Clinic Carolina Bone
Charlotte, North Carolina, 28210
United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
United States
St. Louis Center for Clinical Research
St. Louis, Missouri, 63128
United States
Hospital for Joint Disease
New York City, New York, 10003
United States
Tampa Medical Group
Tampa, Florida, 33614
United States
St. Louis University Solutions
St. Louis, Missouri, 63104
United States
Low Country Rheumatology
Charleston, South Carolina, 29406
United States
Radiant Research
San Antonio, Texas, 75231
United States
Physicians Clinic of Spokane
Spokane, Washington, 99204
United States
Division of Rheumatology/Internal Medicine
Ann Arbor, Michigan, 48109-0358
United States
Arthritis, Rheumatic and Back
Vorhees, New Jersey, 08043
United States
Additional Information:
Study ID Numbers: 3066A3-206-WW;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076206
Other Rheumatoid Arthritis Studies:
1. Long term safety and tolerability of an investigational drug in patients with rheumatoid arthritis
2. Relaxation Response Training for the Treatment of Rheumatoid Arthritis
3. Genetic Registry for Rheumatoid Arthritis
4. Efficacy and Safety of Investigational Drug in Patients with Rheumatoid Arthritis Who Failed at Least One DMARD (Disease Modifying Anti-Rheumatic Drug)
5. Genetics of Rheumatoid Arthritis
Related Studies:
Other Rheumatoid Arthritis Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy
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