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ACTEMRA(TM) (tocilizumab) Third Phase III Study Results Show Significant Improvement In Symptoms Of Patients With Rheumatoid Arthritis
Roche today announced that
results from the ACTEMRA(TM) RADIATE (RheumAtoiD ArthritIs Study in
Anti-TNF FailurEs) trial successfully met its primary endpoint in patients
with moderate to severe rheumatoid arthritis (RA) who failed to respond to
anti-tumor necrosis factor treatments (anti-TNFs).
The trial - the third multinational Phase III study of ACTEMRA outside
of Japan - showed that a greater proportion of patients treated with
ACTEMRA plus methotrexate (4 mg/kg or 8 mg/kg) achieved a significant
reduction in the signs and symptoms of RA as evaluated by ACR20 following
24 weeks of treatment, compared to those who were treated with placebo plus
methotrexate.
ACTEMRA was generally well tolerated; the most common adverse events
reported more frequently in the ACTEMRA arms of the RADIATE trial were
nausea, headache, nasopharyngitis, diarrhea and upper respiratory tract
infection.
"The study results reconfirm the findings from the previous
multinational trials that interleukin-6 receptor inhibition is a novel
mechanism for reducing inflammation caused by RA," said Lars Birgerson,
M.D., Ph.D., Global Head Medical Affairs, Roche. "The data demonstrate that
ACTEMRA can potentially offer an effective approach in reducing the signs
and symptoms of RA, particularly when therapies such as anti-TNFs prove
insufficient."
Data from this trial will be submitted for presentation at upcoming
national scientific meetings. In addition, other Phase III trials exploring
ACTEMRA in RA are ongoing with another study scheduled to report in 2007.
About the RADIATE Study
The RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) study is
a three-arm, randomized, double-blind, placebo-controlled study designed to
evaluate the safety and efficacy of ACTEMRA plus methotrexate (4 mg/kg or 8
mg/kg) compared to placebo plus methotrexate in RA patients who had an
inadequate response to anti-TNFs alone. Patients received either ACTEMRA
intravenously (4 mg/kg or 8 mg/kg) every four weeks plus methotrexate
weekly or placebo infusions every four weeks plus methotrexate weekly.
Data from the study were analyzed to determine patients' response to
treatment by using three standard assessments: ACR score (1), developed by
the American College of Rheumatology (ACR), DAS28 (2), a measurement of RA
disease activity, and EULAR response criteria (3), a measurement of
treatment response. The study included 498 patients at 128 trial sites in
13 countries, including the United States.
The RADIATE trial is one of five Phase III clinical studies designed to
investigate ACTEMRA as a potential new treatment for RA. Roche and Chugai
have initiated the collaborative clinical development program that has
enrolled a total of more than 4,000 patients in 41 countries including the
United States and several European countries.
About ACTEMRA (tocilizumab)
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting
monoclonal antibody and represents a novel mechanism of action to treat RA.
Studies suggest that reducing the activity of IL-6, one of several key
cytokines involved in the inflammatory process, may reduce inflammation of
the joints. The global ACTEMRA Phase III clinical development program is
designed to evaluate this clinical finding. The compound is not currently
approved in the United States.
The most common adverse events reported in ACTEMRA global clinical
studies are upper respiratory tract infections, headache, nasopharyngitis
and hypertension. As with other biological disease modifying anti-rheumatic
drugs (DMARDs), serious infections have been reported in some patients
treated with ACTEMRA.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by inflammation of the membrane lining in the joints. This
inflammation causes a loss of joint shape and function, resulting in pain,
stiffness and swelling, ultimately leading to irreversible joint
destruction and disability. Characteristics of RA include redness,
swelling, pain, and movement limitation around joints of the hands, feet,
elbows, knees and neck that leads to loss of function. In addition, the
systemic symptoms of RA include fatigue, decreased hemoglobin and
osteoporosis and may contribute to shortening life expectancy by affecting
major organ systems. After 10 years, less than 50% of patients can continue
to work or function normally on a daily basis. RA affects more than 21
million people worldwide with approximately 2.1 million people affected in
the United States.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years in the U.S., Roche has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2006, Roche was named
one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to
Sell For (Selling Power), and one of AARP's Top Companies for Older
Workers, and in 2005, Roche was named one of Fortune magazine's Best
Companies to Work For in America. For additional information about the U.S.
pharmaceuticals business, visit our websites: http://www.rocheusa.com or
http://www.roche.us.
References
(1) ACR20, ACR50 and ACR70 represent the percentage of reduction (20%, 50%
or 70%) in certain RA symptoms and measures the number of tender
and swollen joints, pain, patient's and physician's global assessments
and certain laboratory markers. An ACR70 response is considered
exceptional and represents a significant improvement in a patient's
condition.
(2) The Disease Activity Score (DAS)28 is a combined index that measures
disease activity in patients with RA. It combines information from 28
tender and swollen joints (range 0-28), erythrocyte sedimentation rate,
and a general health assessment on a visual analog scale. The level of
disease activity is interpreted as low (DAS28 less than or equal to
3.2), moderate (3.2 < DAS28 less than or equal to 5.1) or high (DAS28
>5.1). DAS28
ACTEMRA (tm) (tocilizumab) a treia fazã III de studiu, rezultatele aratã îmbunãtãþire semnificativã în simptome de pacienþi cu poliartritã reumatoidã - ACTEMRA(TM) (tocilizumab) Third Phase III Study Results Show Significant Improvement In Symptoms Of Patients With Rheumatoid Arthritis - articole medicale engleza - startsanatate