Cardiovascular Diseases — Atherosclerosis in Rheumatoid Arthritis
Citation(s)
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Olsen NJ, Stein CM New drugs for rheumatoid arthritis. N Engl J Med. 2004 May 20;350(21):2167-79. Review.
Pincus T, Sokka T, Kautiainen H Patients seen for standard rheumatoid arthritis care have significantly better articular, radiographic, laboratory, and functional status in 2000 than in 1985. Arthritis Rheum. 2005 Apr;52(4):1009-19.
Pincus T, Sokka T Uniform databases in early arthritis: specific measures to complement classification criteria and indices of clinical change. Clin Exp Rheumatol. 2003 Sep-Oct;21(5 Suppl 31):S79-88. Review.
Pincus T, Yazici Y, Sokka T, Aletaha D, Smolen JS Methotrexate as the "anchor drug" for the treatment of early rheumatoid arthritis. Clin Exp Rheumatol. 2003 Sep-Oct;21(5 Suppl 31):S179-85. Review.
Sokka T, Pincus T An Early Rheumatoid Arthritis Treatment Evaluation Registry (ERATER) in the United States. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S178-81.
Sokka T, Pincus T Contemporary disease modifying antirheumatic drugs (DMARD) in patients with recent onset rheumatoid arthritis in a US private practice: methotrexate as the anchor drug in 90% and new DMARD in 30% of patients. J Rheumatol. 2002 Dec;29(12):2521-4.
Sokka T, Pincus T Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor alpha agents in rheumatoid arthritis. Arthritis Rheum. 2003 Feb;48(2):313-8.
Sokka T, Pincus T Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or american college of rheumatology criteria for remission. J Rheumatol. 2003 Jun;30(6):1138-46.
Sokka T, Willoughby J, Yazici Y, Pincus T Databases of patients with early rheumatoid arthritis in the USA. Clin Exp Rheumatol. 2003 Sep-Oct;21(5 Suppl 31):S146-53. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
