Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001421
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Methimazole to Treat Polymyositis and Dermatomyositis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of the Role of Methimazole in Patients With Polymyositis and Dermatomyositis
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the safety and effectiveness of the drug methimazole in treating polymyositis and dermatomyositis-inflammatory muscle diseases causing weakness and muscle wasting Although it is not known what causes of these diseases abnormal immune function is thought to be involved Recent studies indicate that methimazole which has been used for many years to treat thyroid disease may alter immune activity by affecting the interaction between white blood cells called lymphocytes and certain molecules on cell surfaces This study will examine the effects of methimazole on immune activity and muscle strength in patients with inflammatory muscle diseases and evaluate the drug side effects
Patients with polymyositis and dermatomyositis who have normal thyroid function may be eligible for this study age requirement Candidates will undergo a history and physical examination blood and urine tests chest X-ray muscle strength testing daily living skills questionnaire and speech and swallowing evaluation magnetic resonance imaging of muscles and muscle biopsy removal of a small piece of muscle tissue under local anesthetic When indicated some candidates may also have cancer screening tests for example mammogram Pap smear a lung function test to measure breathing capacity or an electromyogram in which small needles are inserted into a muscle to measure the electrical activity
Participants will take 30 mg of methimazole by mouth twice a day for 6 months They will have blood tests weekly for the first 2 weeks and then every other week for the rest of the study to measure blood counts and liver and thyroid function Blood will also be drawn for white blood cell studies during the screening evaluation at the beginning of therapy 6 to 12 weeks after therapy starts at the end of the 6-month treatment period and 1 and 3 months after therapy ends Muscle enzyme and urine tests will be done once a month During drug treatment patients will have periodic physical examinations and blood and muscle function tests to evaluate the response to therapy
Patients with polymyositis and dermatomyositis who have normal thyroid function may be eligible for this study age requirement Candidates will undergo a history and physical examination blood and urine tests chest X-ray muscle strength testing daily living skills questionnaire and speech and swallowing evaluation magnetic resonance imaging of muscles and muscle biopsy removal of a small piece of muscle tissue under local anesthetic When indicated some candidates may also have cancer screening tests for example mammogram Pap smear a lung function test to measure breathing capacity or an electromyogram in which small needles are inserted into a muscle to measure the electrical activity
Participants will take 30 mg of methimazole by mouth twice a day for 6 months They will have blood tests weekly for the first 2 weeks and then every other week for the rest of the study to measure blood counts and liver and thyroid function Blood will also be drawn for white blood cell studies during the screening evaluation at the beginning of therapy 6 to 12 weeks after therapy starts at the end of the 6-month treatment period and 1 and 3 months after therapy ends Muscle enzyme and urine tests will be done once a month During drug treatment patients will have periodic physical examinations and blood and muscle function tests to evaluate the response to therapy
Detailed Description:
This open label pilot study will assess the 1 activity of methimazole MMI a down-regulator of MHC Class I transcription used in treatment of autoimmune thyroiditis AIT on the tissue expression of HLA class I and its 2 efficacy as measured by serum muscle enzyme levels and manual muscle testing in up to twenty patients with dermatomyositis DM or polymyositis PM Participants will have persistent weakness laboratory evidence of inflammation and be on a stable regimen of medication to control their myopathy MMI will be administered orally at 30 mg twice a day for six months Patients will be evaluated for alteration of HLA Class I expression in muscle and peripheral blood lymphocytes PBL and drug-related toxicities during the study and for three months after the discontinuation of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-AR-0139 | None | None | None |