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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00335985 |
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Date of registration:
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08/06/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
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Scientific title:
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A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00335985 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Nobuyuki Miyasaka, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tokyo Medical and Dental University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who have been defined as "definite" based on the criteria of Bohan and Peter
for polymyositis and dermatomyositis.
- Patients who are defined as steroid-resistant ones based on the changes of scores on
manual muscle testing (MMT) and serum levels of creatine kinase (CK) during
observation period before administration of drug.
Exclusion Criteria:
- Patients with malignant tumors.
- Patients with acute interstitial pneumonia, including acute exacerbation of chronic.
- Patients with severe muscular atrophy for a long period.
- Patients with severe infectious disease.
- Patients who have the anamnesis of shock or hypersensitivity to this drug.
- Patients with severe hepatic disorder or severe renal disorder.
- Patients who have the anamnesis of cerebral infarction or ischemic heart disease, or
who having symptom of these diseases.
- Patients who have been diagnosed as IgA deficiency in their past history.
- Pregnant, lactating, and probably pregnant patients, and patients who want to become
pregnant.
- Patients who were administered immunoglobulin dosage within 6 weeks before consent.
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dermatomyositis
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Polymyositis
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Intervention(s)
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Drug: GB-0998
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Drug: Placebo of GB-0998
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Primary Outcome(s)
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Changes in manual muscle strength (MMT) scores
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Adverse events and laboratory tests
[Time Frame: 8 weeks]
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Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)
[Time Frame: 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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