Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatom… (NCT00335985) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)
Japan26 participantsStarted 2006-06
Plain-language summary
This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition, to assess the safety of GB-0998.
Who can participate
Age range
16 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.