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Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW) 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 Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW) Clinical research trials and Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW) 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 Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW). Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW) 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 Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW) clinical trial. Participants frequently obtain the most expert healthcare available for their Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW) 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 > "R" Clinical Trials Conditions > Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW)  Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW)
Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW)
For Condition: Multiple Sclerosis
Status: No longer recruiting
Sponsor(s): Immunex Corporation ,
Synopsis: This Phase 4 multicenter, open-label study is being conducted to obtain long-term information on how Novantrone is tolerated in patients with multiple sclerosis (MS) when it is given as recommended in the package insert. Five hundred patients with MS who receive Novantrone will be enrolled at up to 50 sites in the United States. Patients must have a diagnosis of MS as shown by clinical assessment or laboratory tests. Patients are eligible to participate in the study if they have a diagnosis of either secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses). Patients with primary progressive disease cannot be included in this study. All patients will receive commercial open-label Novantrone at 12 mg/m2 administered intravenously. Doses of Novantrone will be administered approximately every 3 months until either a 140 mg/m2 cumulative dose is reached, the patient or physician chooses to discontinue or interrupt therapy, or there is an adverse event that precludes further therapy. All patients will be evaluated for left ventricular ejection fraction (LVEF) by echocardiography or MUGA at baseline and again before each dose when a cumulative dose of 100 mg/m2 has been reached. LVEF evaluations will also be performed annually after Novantrone has been discontinued, for up to 5 years after administration of the first dose of Novantrone. Novantrone will not be administered to patients with a LVEF less than 50%. Patients will need to pay for or arrange for payment of their Novantrone.
Details: Novantrone is an immunosuppressive agent that has been evaluated as a disease-modifying therapy in patients with multiple sclerosis. Two randomized, controlled studies (Phase 2 and Phase 3) demonstrated the efficacy and tolerability of Novantrone in MS patients and led the FDA to approve its use in MS patients with secondary (chronic) progressive, progressive relapsing or worsening relapsing-remitting disease.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: - Platelet count greater than 100,000/microliter. - Granulocyte count greater than 2000 cells/microliter. - Negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control. - For patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of Novantrone. - Signed informed consent. Any of the following will exclude the patient from this registry: - Presence of cardiac risk factors: - History of congestive heart failure - LVEF less than 50% as determined by echocardiography or MUGA - Previous treatment with Novantrone, other anthracenediones, or anthracyclines - Prior mediastinal radiotherapy or total lymphoidal irradiation - AST, ALT, bilirubin greater than 2 times upper limits of normal. - Severe untreated infection (including current urinary tract infection). - Nursing or pregnant women. Planned Total Enrollment: 500 patients
Total Enrollment: 500
Location and Contact Information:
Registrat, Inc., 2525 Harrodsburg Road, Suite 305
Lexington, Kentucky, 40504
United States
Additional Information:
Study ID Numbers: 031.0007;
Study Start Date: January 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016614
Other Multiple Sclerosis Studies:
1. Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis
2. Yoga: Effect on Attention in Aging & Multiple Sclerosis
3. Safety of RG2077 in Patients With Multiple Sclerosis
4. Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)
5. Zenapax to Treat Multiple Sclerosis
Related Studies:
Other Multiple Sclerosis Clinical Trials
Other Kentucky Clinical Trials
Other Lexington Clinical Trials
Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW)
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