Trial record 7 of 40 for:
Open Studies | "Dermatomyositis"
Dermatomyositis and Polymyositis Registry (ADAPT)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by Phoenix Neurological Associates, LTD
Sponsor:
Phoenix Neurological Associates, LTD
Information provided by (Responsible Party):
Phoenix Neurological Associates, LTD
ClinicalTrials.gov Identifier:
NCT01637064
First received: July 6, 2012
Last updated: October 29, 2014
Last verified: October 2014
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Purpose
By creating a registry, physicians will have the opportunity to understand the clinical outcomes of Myositis patients treated with Acthar. Despite the availability of clinical exams, muscle biopsies, and other testing, it is surmised that there may be a more important classification of myositis that physicians are not diagnosing which could possibly lead to improper treatment due to inaccurate diagnosis. There may be several types of immune and inflammatory myositis (IIM) that do not fit well into the typical sub classifications of myositis.
| Condition | Intervention |
|---|---|
|
Dermatomyositis Polymyositis |
Drug: Acthar |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| Official Title: | Acthar Dermatomyositis and Polymyositis Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
idiopathic inflammatory myopathy
Drug Information available for:
Corticotropin
Genetic and Rare Diseases Information Center resources:
Dermatomyositis
Giant Cell Arteritis
Idiopathic Myopathy
Juvenile Dermatomyositis
Polymyositis
Rhizomelic Pseudopolyarthritis
U.S. FDA Resources
Further study details as provided by Phoenix Neurological Associates, LTD:
Primary Outcome Measures:
- Determining if Acthar treatment improves disease progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]To create and maintain a registry linking clinical information, dosing and clinical response in patients with refractory myositis and to determine if Acthar treatment improves disease progression
Secondary Outcome Measures:
- Subgroups may predict response to Acthar therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine if there are different subgroups that can be defined myopathologically that may predict response to Acthar therapy.
Biospecimen Retention: None Retained
This is a retrospective and prospective study
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2013 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Acthar
Physicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week.
Other Name: ACTH
Retrospective and prospective data will be collected from physicians who have prescribed Acthar to myositis patients to determine what specific characteristics each patient has based on biopsy analysis, laboratory results, and clinical exams. Through biopsy analysis, subcategories of IIM will be determined and could illustrate which of these IIMs may be more responsive to Acthar therapy.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All sites chosen are well-established universities, academic centers or private practices that specialize in neuromuscular diseases. These are physicians who have several myositis patients and who are prescribing or would prescribe Acthar to myositis patients
Criteria
Inclusion Criteria:
- Age 18-85
- Male or Female
- Clinical or pathologic diagnosis of polymyositis or dermatomyositis
- Capable of providing informed consent and complying with treatment regimen
Exclusion Criteria:
- History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex
- Recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin
- Any other co-morbid condition which would make completion of the trial unlikely
- If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637064
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637064
Contacts
| Contact: Todd D Levine, MD | 602 258 2863 | levine865@aol.com | |
| Contact: Lynne Flynn, CCRC | 602 258 2863 | lynneflynn@pnal.net |
Locations
| United States, Arizona | |
| PNA Center for Neurological Research | Recruiting |
| Phoenix, Arizona, United States, 85018 | |
| Contact: Lynne Flynn, CCRC 602-258-2863 lynneflynn@pnal.net | |
| Principal Investigator: Todd D Levine, MD | |
| United States, California | |
| Ara Dikranian MD | Recruiting |
| San Diego, California, United States, 92108 | |
| United States, Missouri | |
| Neurology INC | Recruiting |
| Columbia, Missouri, United States, 65201 | |
| Contact: Beth Crum, CRC bcrum@neurologyinc.com | |
| Principal Investigator: Justine Malone, MD | |
| United States, New York | |
| New York Methodist Hospital | Recruiting |
| Brooklyn, New York, United States, 11215 | |
| Contact 718-780-5740 | |
| Principal Investigator: Petros Efthimiou, MD | |
| United States, Vermont | |
| University of Vermont | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Mark Tomase 802-656-9914 | |
| Principal Investigator: Rup Tandan, MD | |
Sponsors and Collaborators
Phoenix Neurological Associates, LTD
Investigators
| Principal Investigator: | Todd D Levine, MD | Phoenix Neurological Associates, LTD | |
| Principal Investigator: | Petros Efthimiou, MD | New York Methodist Hospital | |
| Principal Investigator: | Ara Dikranian, MD | Ara Dikranian MD | |
| Principal Investigator: | Justine Malone, MD | Neurology INC | |
| Principal Investigator: | Rup Tandan, MD | University of Vermont |
More Information
No publications provided
| Responsible Party: | Phoenix Neurological Associates, LTD |
| ClinicalTrials.gov Identifier: | NCT01637064 History of Changes |
| Other Study ID Numbers: | ADAPT |
| Study First Received: | July 6, 2012 |
| Last Updated: | October 29, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Phoenix Neurological Associates, LTD:
|
Myositis Acthar treatment |
Additional relevant MeSH terms:
|
Dermatomyositis Polymyalgia Rheumatica Polymyositis Connective Tissue Diseases Muscular Diseases Musculoskeletal Diseases |
Myositis Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Skin Diseases |
ClinicalTrials.gov processed this record on March 03, 2015