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Sponsored by: |
Northwestern University |
Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00278564 |
Myositis is a disease, believed to be due to immune cells, cells which normally protect the body, but are now attacking the muscles and other organ systems within body. As a result, the affected muscles and organs fail to work properly causing weakness, difficulty swallowing, skin rash, respiratory problems, heart problems, joint stiffness, soft tissue calcification and vasculitis (blood circulation problems). The likelihood of progression of this disease is high. This study is designed to examine whether treating patients with high dose cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein that kills the immune cells that are thought to be causing this disease), followed by return of previously collected blood stem cells will stop the progression of myositis.
Condition | Intervention | Phase |
Myopathy |
Procedure: hematopoietic stem cell transplantation |
Phase I |
MedlinePlus related topics: | Muscle Disorders Myositis |
Drug Information available for: | Cyclophosphamide |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Transplantation in Patients With Refractory Idiopathic Inflammatory Myopathy Diseases: A Phase I Trial |
Estimated Enrollment: | 10 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2015 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Age > 16 years and < 70 years at the time of pretransplant evaluation.
2. An established diagnosis of polymyositis, dermatomyositis, juvenile polymyositis/dermatomyositis, myositis associated with other collagen diseases. Diagnosis requires electrophysiological studies and histopathologic features. Histological evidence of active myositis is mandatory at entry. If patient had dermatomyositis/polymyositis associated with malignancy, the patient has to be free of malignancy for 5 years and considered to be cured.
3. Patients who failed conventional treatment of at least 3 months duration including high-dose corticosteroids (equivalent dosage of prednisone >1.0 mg/kg/day to start), and must also have failed two or more of the followings: cyclophosphamide, azathioprine, 6-MP, methotrexate, tacrolimus, cyclosporin A, mycophenolate mofetil, TNF inhibitor (e.g. etanercept), IVIG or any other immunosuppressive drugs or immune modulating drugs.
4. Failure is defined by (one or more of the following) (not caused by unrelated conditions):
Exclusion Criteria:
Significant end organ damage such as (not caused by IIM):
Contact: Dzemila Spahovic, MD | 312-908-0059 | d-spahovic@northwestern.edu |
United States, Illinois | |||||
Northwestern University, Feinberg School of Medicine | Recruiting | ||||
Chicago, Illinois, United States, 60611 | |||||
Principal Investigator: Richard Burt, MD | |||||
Sub-Investigator: Walter Barr, MD | |||||
Sub-Investigator: Robert Suffit, MD | |||||
Sub-Investigator: Kathleen Quigley, R.N. | |||||
Sub-Investigator: Kimberly Yaung, RN |
Northwestern University |
Principal Investigator: | Richard Burt, MD | Northwestern University |
Responsible Party: | Northwestern University ( Robert Craig, MD ) |
Study ID Numbers: | NU FDA IIM.Auto2003 |
First Received: | January 15, 2006 |
Last Updated: | May 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00278564 |
Health Authority: | United States: Food and Drug Administration |
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