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Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate Clinical research trials and Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate. Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate clinical trial. Human subjects frequently get the finest healthcare available for their Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate  Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
For Condition: Rheumatoid Arthritis
Status: No longer recruiting
Sponsor(s): MedImmune, Inc. ,
Synopsis: To compare, as a preliminary analysis, the effects of subcutaneously administered MEDI-522 versus placebo at 6 months on disease activity and progression of structural joint damage in patients with rheumatoid arthritis (RA), who have active disease despite ongoing treatment with methotrexate (MTX) with or without hydroxychloroquine (HCQ) and/or sulfasalazine (SSZ).
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Patients must meet all of the following criteria: 1. Age greater than or equal to 18 (reached 18th birthday or later) at the time of the first dose of study drug 2. Written informed consent obtained from the patient 3. Sexually active females, unless surgically sterile or at least one year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, injectable, or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug, and must agree to continue using such precautions through 3 months after their last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. 4. A diagnosis of RA as defined by American College of Rheumatology (ACR) criteria, which is currently active, as defined by the presence of at least 6 swollen and 6 tender joints involving the hands, wrists, elbows, knees, ankles, or feet and a CRP and/or ESR>Upper Limits of Normal (ULN). 5. Treatment with a stable dose level and frequency of methotrexate for at least 8 weeks prior to study randomization. The patients may also be taking hydroxychloroquine and/or sulfasalazine concurrently with methotrexate. These drugs must also be at stable dose levels and frequencies for at least 8 weeks prior to randomization. Patients currently receiving treatment with stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, or prednisone (less than or equal to 10 mg/day) will be permitted to continue these medications. Analgesics, including acetaminophen, talwin, propoxyphene, tramadol hydrochloride, codeine or codeine with acetaminophen, hydrocodone, oxycontin, and related medications, will also be permitted. All of these drugs must be at stable dose levels and frequencies for at least 4 weeks prior to study randomization. 6. Prior to randomization (must be within 21 days of the first administration of the study drug), all of the following: WBC 3,800/mm³; platelet count 140,000/mm³; AST, ALT, BUN, or creatinine<1.5 x ULN; stool negative for occult blood; and thyroxine (T4) within normal limits. (Patients with an elevated T4 but with both free T4 and TSH levels within normal limits may be eligible after review by the MedImmune medical monitor.) 7. Willing to forego other forms of experimental treatment during study through Study Day 364 8. Able and willing to complete assessment questionnaires. 9. Willing to participate in study through Study Day 413. Exclusion Criteria Patients must have none of the following: 1. Severe active RA, which in the opinion of the investigator currently requires an alternative form of therapy 2. Acute illness at the start of the study 3. Evidence of significant active infection, such as fever greater than or equal to 38.0°C (100.5°F) 4. Known or suspected infection with human immunodeficiency virus (HIV) or other evidence of clinically significant immune deficiencies 5. Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody 6. Insulin-dependent diabetes mellitus that is recent-onset or unstable 7. Evidence of active or latent tuberculosis, which may include a positive PPD skin test result (greater than or equal to 10 mm induration), unless appropriate INH prophylaxis for tuberculosis previously given; a chest X-ray possibly consistent with tuberculosis; or household contact with a patient with active tuberculosis 8. A medical history or evidence of clinically important chronic infection, recurrent (3 or more) infections in the past 6 months requiring antibiotics, or an infection in the past month requiring systemic antibiotics 9. Receipt of any investigational drug therapy, except MEDI-522, within 3 months prior to study randomization (use of licensed agents for indications not listed in the package insert is permitted) 10. Current or any past therapy with anti-TNF biologic antagonists including etanercept, infliximab, and adalimumab 11. Current therapy with cyclosporin A, leflunomide, cyclophosphamide, azathioprine, gold salts, d-penicillamine, mycophenylate mofetil, minocycline or anakinra. These drugs must have been discontinued at least 4 weeks prior to study randomization. 12. Prednisone or equivalent at >10 mg per day orally in the 8 weeks before study randomization. Intraarticular, periarticular, or other forms of parenteral injection of corticosteroids are also not permitted in the 8 weeks prior to study randomization. 13. History of allergic disease or reactions likely to be exacerbated by any component of MEDI-522 14. History of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months 15. Known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin 16. Elective surgery planned during the study period through Study Day 413 17. Cardiovascular disease that is unstable, such as recent-onset angina, or angina with increasing frequency or severity, or recent myocardial infarction (within past 1 year without definitive corrective surgery such as coronary bypass graft or angioplasty) 18. Neurological disease, such as multiple sclerosis, previous stroke, clinically significant cerebrovascular disease, or other forms of organic brain disease that is clinically significant 19. Pulmonary, hepatic, renal, or hematological disease that is unstable and progressive, or clinically severe 20. Pregnancy (all females, unless surgically sterile or at least one year post-menopausal, must have a negative urine pregnancy test on Study Day 0, prior to dosing) 21. Nursing mother 22. History of alcohol or drug abuse within past 2 years 23. Evidence on physical examination of rheumatoid or other types of vasculitis.
Total Enrollment:
Location and Contact Information:
Sanford S. Hartman
Decatur, Georgia, 30033
United States
RIMA
St. Louis, Missouri, 63131
United States
Radiant Research
Dallas, Texas, 75235
United States
Centre Inflammatory Arthritis Disease Studies
Winnipeg, Manitoba, R3N OK6
Canada
Sun Valley Arthritis Center
Glendale, Arizona, 85308
United States
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6
Canada
The University of Alabama at Birmingham
Birmingham, Alabama, 35249-7201
United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474
United States
Arthritis Consultants, Inc.
St. Louis, Missouri, 63141
United States
Health Research Institute
Oklahoma City, Oklahoma, 73109
United States
University of Arizona
Tucson, Arizona, 85724
United States
The Physician's Clinic of Spokane
Spokane, Washington, 99204
United States
University of Utah Medical Hospital
Salt Lake City, Utah, 84132
United States
Gundersen Clinic Ltd.
La Crosse, Wisconsin, 54601
United States
Charlton Medical Center
Hamilton, Ontario, L8N 1Y2
Canada
The Arthritis Program Research Group Inc.
Newmarket, Ontario, L3Y 3R7
Canada
The Center for Rheumatology
Albany, New York, 12206
United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730
United States
Richmond Health Science Center
Richmond, British Columbia, V7C 5L9
Canada
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M1
Canada
Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas, 79410
United States
K-W Musculoskeletal Research, Inc.
Kitchener, Ontario, N2M 5N6
Canada
Thornton Hospital
La Jolla, California, 92037-0943
United States
Arthritis Centre
Winnipeg, Manitoba, R3A 1M4
Canada
Centre for Rheumatology, Immunology & Arthritis
Ft. Lauderdale, Florida, 33334
United States
Fayetteville Diagnostic Clinic, Ltd.
Fayetteville, Arkansas, 72703
United States
Rheumatology Associates of New Jersey
Teaneck, New Jersey, 07666
United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
United States
Arizona Research & Education
Phoenix, Arizona, 85012
United States
MAC Research, Inc.
Hamilton, Ontario, L8N 2B6
Canada
Rheumatology Northwest/Clinical Trials Northwest
Yakima, Washington, 98902
United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239
United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124
United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792-3244
United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
United States
Rheumatic Disease Center of Montreal
Montreal, Quebec, H3Z 2Z3
Canada
Midtown Medical Center
Saskatoon, Saskatchewan, S7K 0H6
Canada
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454
United States
Arthritis and Rheumatic Disease Specialty
Aventura, Florida, 33180
United States
Oklahoma Center for Arthritis Therapy and Research Inc.
Tulsa, Oklahoma, 74114
United States
Additional Information:
Study ID Numbers: MI-CP100;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069017
Other Rheumatoid Arthritis Studies:
1. Infliximab for the Treatment of Early Rheumatoid Arthritis
2. Genetic Registry for Rheumatoid Arthritis
3. Meditation-based stress reduction in rheumatoid arthritis
4. Identification of Genes Associated with Lung Disease in Patients with Rheumatoid Arthritis
5. Genetics of Rheumatoid Arthritis
Related Studies:
Other Rheumatoid Arthritis Clinical Trials
Other Saskatchewan Clinical Trials
Other Saskatoon Clinical Trials
Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients with Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
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