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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

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3 Different Dose Levels Of CCI-779 In Subjects With Active Rheumatoid Arthritis On Concomitant Methotrexate Therapy

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