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  • Rheumatoid arthritis  (3)
  • HD-Ara-C/DNR consolidation  (2)
  • 1
    Electronic Resource
    Electronic Resource
    Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma (1988)
    Springer
    Rheumatology international 8 (1988), S. 87-93 
    Details
    ISSN: 1437-160X
    Keywords: Rheumatoid arthritis ; Interferon-gamma ; Double-blind placebo-controlled trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary In a multicenter placebo-controlled double-blind randomized clinical study, 91 patients with rheumatoid arthritis were given 28 days' treatment with recombinant interferon-gamma (50 μg daily for 20 days, then 50 μg each second day up to day 28, given by subcutaneous injection). The aim of the study was to provide a methodologically clear demonstration of the efficacy of treatment with interferon-gamma, using criteria that could be handled by statistical tests. Evaluatable documentation was available for 79 patients, of whom 40 were treated with the active compound. The principal criterion for the statistical evaluation of the therapeutic success was improvement of the Ritchie “joint pain index” or Lansbury “joint pain index” by at least 30% within 28 days. The chi-square test showed superiority of the interferon arm over the placebo arm with an error probability of a〈1%. In addition, efficacy of interferon-gamma was demonstrated in respect of practically all parameters investigated. The frequency of side-effects, including febrile reactions, was the same for the active compound and the placebo. During interferon treatment the daily maximum body temperature was raised by 0.3°C on average, but was below 37.2°C at all times.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00271840
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Results of a phase-II clinical trial on treatment of rheumatoid arthritis with recombinant interferon-gamma (1987)
    Springer
    Rheumatology international 7 (1987), S. 127-132 
    Details
    ISSN: 1437-160X
    Keywords: Rheumatoid arthritis ; Interferon-gamma ; Phase-II clinical trial
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary In an open, non-randomized clinical trial conducted at multiple centres, 49 patients with rheumatoid arthritis were treated with recombinant interferon-gamma for 20 days. The study was carried out in two sub-studies. In the first, the total daily dose of interferon-gamma was 50 μg; in the second, 100 μg. Of the 49 cases, 40 were evaluable for statistical analysis; 24 of these patients (60%) responded to therapy, according to the criteria of a successful outcome laid down in the study protocol, and were classified as responders. In responders, the clinical parameters investigated improved with both dosages. The lower dosage differed from the higher one in having a markedly lower incidence of side-effects. The results lead to the conclusion that a randomized double-blind phase-III clinical trial should be performed.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00270465
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis (1992)
    Springer
    Rheumatology international 12 (1992), S. 175-185 
    Details
    ISSN: 1437-160X
    Keywords: Interferon gamma ; Rheumatoid arthritis ; Controlled clinical trial ; Multicenter
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary The controlled clinical trial reported here is part of a multicenter clinical and basic research project, sponsored by the German Federal Minister of Science and Technology, directed by a standing commission of the president of the Max-Planck-Gesellschaft, and coordinated by the Max-Planck-Institut für Biochemie, München. Overall, 249 patients with rheumatoid arthritis (RA) were enrolled by 16 participating hospitals. In addition to NSAID treatment, patients were randomly given either interferon gamma (IFN-γ) or placebo. In the IFN-γ group, 107 patients were evaluated and in the control group, 116 patients were evaluated. The response rate after 3 months of treatment, according to joint pain indexes, was significantly higher in the IFN-γ group with an error probability of 1%. IFN-γ was able to reduce the quantity of corticosteroids administered. Compared with the control group, the IFN-γ group benefited considering all parameters measured. Most important side effects were transient fever and transient influenza-like symptoms; all other adverse events were comparable in both groups.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00302149
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    Paper (German National Licenses)
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  • 4
    Electronic Resource
    Electronic Resource
    High-dose cytosine arabinoside and daunorubicin postremission therapy in adults with de novo acute myeloid leukemia Long-term follow-up of a prospective multicenter trial (1995)
    Springer
    Annals of hematology 71 (1995), S. 219-225 
    Details
    ISSN: 1432-0584
    Keywords: Key words De novo AML ; Adults ; HD-Ara-C/DNR consolidation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  A total of 149 consecutive de novo AML patients aged 50 years or less (median age = 37 years) were enrolled in this prospective multicenter trial initiated in May 1985. All patients received the same induction and early consolidation therapy with daunorubicin (DNR), cytosine arabinoside (Ara-C), and etoposide (DAV). High-dose Ara-C/DNR therapy included Ara-C at 3 g/m2, in 12 doses (HD-Ara-C/DNR I) and eight doses (HD-Ara-C/DNR II), followed by DNR 30 mg/m2 for 3 days. A complete remission (CR) was achieved in 104 (70%) patients; 61 complete responders received at least one cycle with HD-Ara-C/DNR. If those patients who were transplanted in first CR (n = 26), were not considered, the median relapse-free-survival (MRFS) of the remaining 78 patients was 15 months, with a probability of relapse-free survival (RFS) at 116 months of 30% (95% CI, 20–40%) after a median follow-up of 95 months. The MRFS of the HD-Ara-C/DNR consolidated patients was 25 months, with a probability of RFS at 116 months of 37% (95% CI, 24–50%). If all patients who were transplanted (n = 44) were not considered, the median survival time (MST) was 18 months with a probability of being alive at 118 months of 24% (95% CI, 16–33%). MST of the HD-Ara-C/DNR consolidated patients was 58 months with a survival probability of 46% (95% CI, 31–60%) at 118 months. Prognostic factor analysis did not reveal any significant influence of age, sex, FAB subtype, white blood cell count, hemoglobin level, thrombocyte count, LDH, or response to the first induction course on RFS of the HD-Ara-C/DNR consolidated patients. In summary, HD-Ara-C/DNR consolidation can improve the long-term outcome of a subgroup of de novo AML patients. Further improvement of the outcome seems to depend on the identification of patients with an inferior outcome under that strategy who might benefit from alternative treatment strategies.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01744371
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    Paper (German National Licenses)
    Fulltext
  • 5
    Electronic Resource
    Electronic Resource
    High-dose cytosine arabinoside and daunorubicin postremission therapy in adults with de novo acute myeloid leukemia (1995)
    Springer
    Annals of hematology 71 (1995), S. 219-225 
    Details
    ISSN: 1432-0584
    Keywords: De novo AML ; Adults ; HD-Ara-C/DNR consolidation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract A total of 149 consecutive de novo AML patients aged 50 years or less (median age = 37 years) were enrolled in this prospective multicenter trial initiated in May 1985. All patients received the same induction and early consolidation therapy with daunorubicin (DNR), cytosine arabinoside (Ara-C), and etoposide (DAV). High-dose Ara-C/DNR therapy included Ara-C at 3 g/m2, in 12 doses (HD-Ara-C/DNR I) and eight doses (HD-Ara-C/DNR II), followed by DNR 30 mg/m2 for 3 days. A complete remission (CR) was achieved in 104 (70%) patients; 61 complete responders received at least one cycle with HD-Ara-C/DNR. If those patients who were transplanted in first CR (n=26), were not considered, the median relapsefree-survival (MRFS) of the remaining 78 patients was 15 months, with a probability of relapse-free survival (RFS) at 116 months of 30% (95% CI, 20–40%) after a median follow-up of 95 months. The MRFS of the HD-Ara-C/DNR consolidated patients was 25 months, with a probability of RFS at 116 months of 37% (95% CI, 24–50%). If all patients who were transplanted (n=44) were not considered, the median survival time (MST) was 18 months with a probability of being alive at 118 months of 24% (95% CI, 16–33%). MST of the HD-Ara-C/DNR consolidated patients was 58 months with a survival probability of 46% (95% CI, 31–60%) at 118 months. Prognostic factor analysis did not reveal any significant influence of age, sex, FAB subtype, white blood cell count, hemoglobin level, thrombocyte count, LDH, or response to the first induction course on RFS of the HD-Ara-C/DNR consolidated patients. In summary, HD-Ara-C/DNR consolidation can improve the long-term outcome of a subgroup of de novo AML patients. Further improvement of the outcome seems to depend on the identification of patients with an inferior outcome under that strategy who might benefit from alternative treatment strategies.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01744371
    Library Location Call Number Volume/Issue/Year Availability
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    Paper (German National Licenses)
    Fulltext
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