Search / Trial NCT00001421

Methimazole to Treat Polymyositis and Dermatomyositis

Launched by NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) · Dec 9, 2002

Apply for Trial

Trial Information

Current as of December 03, 2023

Completed

Keywords

Cytotoxicity Hla Class I Lymphocytes Muscle Myositis Thionamides Dermatomyositis Polymyositis

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. Pa...

Gender

All

Eligibility criteria

  • Diagnosis of Polymyositis or Dermatomyositis.
  • Baseline muscle weakness score of less than or equal to 139 out of 160 on manual testing (MMT).
  • Baseline functional assessment score of less than or equal to 82 out of 91.
  • Ability to provide informed consent to all aspects of the study after full information is provided.
  • Age equal to or older than 18.
  • A diagnosis of classic or definite polymyositis or dermatomyositis (Critieria A and B plus at least one of the three other criteria):
  • Symmetrical proximal muscle weakness;
  • Muscle biopsy abnormalities at some time during their disease:
  • i. degeneration and regeneration of muscle fibers
  • ii. necrosis
  • iii. phagocytosis
  • iv. interstitial mononuclear infiltration;
  • c. Elevation of serum creatinine phosphokinase (CPK), transaminases, lactic dehydrogenase (LDH) or aldolase activity;
  • d. Electromyography (EMG) triad of changes
  • i. small amplitude, short duration polyphasic motor unit potentials
  • ii. fibrillations, positive sharp waves, increased insertional irritability
  • iii. spontaneous bizarre high frequency discharges;
  • e. Typical skin rash of DM.
  • Willingness to undergo 2 muscle biopsies.
  • Evidence of active disease as measured by weakness, and an elevated CK or an active MRI.
  • Must be tapered to a stable dose of steroid equal to or less than 0.50 mg/kg/day equivalent of prednisone for one month prior to the study.
  • If on additional immunosuppressive drugs, the drugs must be maintained at a stable dose for 1 month prior to the initiation of therapy and will be maintained throughout the trial.
  • Women of childbearing potential and men whose partners are of childbearing potential must practice an acceptable form of contraception. No pregnant females or nursing mothers.
  • No history of hepatitis or abnormal liver function tests.
  • No history of prior thyroid disease.
  • No active acute or chronic infections requiring antimicrobial therapy, or serious viral or fungal infections.
  • No preexisting or coexisting malignancy other than basal cell and localized squamous cell carcinoma of the skin.
  • No history of cerebrovascular accidents, seizure disorder, aseptic meningitis, transverse myelitis or central nervous system disease.
  • No history of documented coronary artery disease, cardiomyopathy, greater than first-degree heart block, or dysrhythmia requiring therapy.
  • No confounding medical illness that in the judgement of the investigators would pose added risk for study participants.
  • No anemia requiring maintenance blood transfusions; leukoplakia with WBC less than 3,000 micrograms or absolute neutrophil count less than 2,000 micrograms; and platelet count less than 100,000 micrograms on at least two different occasions.
  • No history of (or current) autoimmune hemolytic anemia.
  • No current anticoagulant therapy.

Attachments

readout_NCT00001421_2023-12-03.pdf

4.5 MB

NCT00001421_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0