Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106184
Status:
COMPLETED
Last Update Posted:
2015-03-04
First Post:
2005-03-21
Brief Title:
Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis DM and Adult Polymyositis PM
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Rituximab Therapy in Refractory Adult and Juvenile Idiopathic Inflammatory Myopathy IIM
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Rituximab is a man-made antibody used to treat certain types of cancer This study will determine whether rituximab is an effective treatment for adult and pediatric patients with dermatomyositis or polymyositis
Study hypotheses 1 The time to improvement in Group A patients receiving rituximab first will occur significantly earlier than in Group B patients receiving rituximab later 2 The proportion of patients improved at Week 8 of the treatment phase will be significantly greater in Group A than in Group B
Study hypotheses 1 The time to improvement in Group A patients receiving rituximab first will occur significantly earlier than in Group B patients receiving rituximab later 2 The proportion of patients improved at Week 8 of the treatment phase will be significantly greater in Group A than in Group B
Detailed Description:
Rituximab is a chimeric murine-human genetically engineered monoclonal antibody directed against the CD20 cluster of differentiation antigen 20 antigen found on the surface of B-lymphocytes and is known to deplete B cells when administered intravenously It is approved to treat non-Hodgkins lymphoma Rituximab has been used for autoimmune diseases such as systemic lupus erythematosus SLE rheumatoid arthritis RA and immune-mediated hematologic disorders It has also been studied and used in small numbers of patients with myositis This study will evaluate the efficacy of rituximab in treating refractory adult and pediatric patients with dermatomyositis and adult polymyositis
A patients participation in this study will last approximately 45 weeks At screening participants will have a physical exam muscle strength assessment an electrocardiogram and blood and urine collection they will also be asked to complete several questionnaires All participants will receive 2 infusions of rituximab and 2 infusions of placebo Participants will be randomly assigned to one of two groups Group A will receive rituximab at Weeks 0 and 1 and placebo at Weeks 8 and 9 Group B will receive placebo at Weeks 0 and 1 and rituximab at Weeks 8 and 9 Each infusion will be given on an outpatient basis over a minimum of approximately 5 hours time
There will be a total of 14 study visits All participants will visit the outpatient clinic at selected time points for muscle strength testing a physical exam disease activity measurements and blood collection During the study participants will be monitored closely for improvement or worsening of their disease and for serious drug related side effects Some participants will be asked if they are willing to undergo 2 muscle biopsy procedures 1 prior to receiving study medication and 1 after receiving study medication to determine the effects of rituximab on muscle tissue
If a participant is unable to locate a near-by clinical center the adult and pediatric centers at the National Institute of Health located in Bethesda Maryland have funds available to assist with travel costs
NIH SUB-STUDY Rituximab to Treat Dermatomyositis and Polymyositis
This study is currently recruiting patients
Sponsored by National Institute of Environmental Health Sciences NIEHS
Information provided by National Institutes of Health Clinical Center CC
Expected Total Enrollment 30
Study start October 2006
Location and Contact Information Patient Recruitment and Public Liaison Office800 411-1222 prplmailccnihgov Phone 1-866-411-1010
The NIH sub-study will take advantage of the multi-center core RIM trial to identify changes in gene expression patterns in muscle skin and peripheral blood and the imaging features and immunopathology of muscle skin and peripheral cells before week 0 and after week 16 therapy These changes will also be correlated with the large number of clinical laboratory and research variables already planned to be collected in the core RIM Study Furthermore knowing specifically which gene expression patterns are altered in resistant patients before rituximab and which are changed after rituximab therapy - in conjunction with flow cytometry of peripheral cells and immunopathology of the tissues - will help in understanding more about the pathogenesis of myositis and the possible contribution of B lymphocytes and their subsets
Patients with dermatomyositis and polymyositis who meet the inclusionexclusion criteria for the core RIM trial may be eligible for this sub-study The following procedures will be conducted in addition to the core RIM trial procedures during the 13 clinic visits over a period of 44 weeks
Weeks 0 16 Muscle and skin biopsy adult only Small samples of muscle and skin tissue will be surgically removed for examination under a microscope
Weeks 0 8 16 44 Skin evaluation and photography The effect of the disease on the skin will be thoroughly evaluated and photographs of any rashes and of the skin around the nails will be taken
Weeks 0 8 16 44 Magnetic resonance imaging MRI All participants will have MRI scans of the skin and of the muscle in the legs Adults will also have an MRI to examine blood flow in the muscle
A patients participation in this study will last approximately 45 weeks At screening participants will have a physical exam muscle strength assessment an electrocardiogram and blood and urine collection they will also be asked to complete several questionnaires All participants will receive 2 infusions of rituximab and 2 infusions of placebo Participants will be randomly assigned to one of two groups Group A will receive rituximab at Weeks 0 and 1 and placebo at Weeks 8 and 9 Group B will receive placebo at Weeks 0 and 1 and rituximab at Weeks 8 and 9 Each infusion will be given on an outpatient basis over a minimum of approximately 5 hours time
There will be a total of 14 study visits All participants will visit the outpatient clinic at selected time points for muscle strength testing a physical exam disease activity measurements and blood collection During the study participants will be monitored closely for improvement or worsening of their disease and for serious drug related side effects Some participants will be asked if they are willing to undergo 2 muscle biopsy procedures 1 prior to receiving study medication and 1 after receiving study medication to determine the effects of rituximab on muscle tissue
If a participant is unable to locate a near-by clinical center the adult and pediatric centers at the National Institute of Health located in Bethesda Maryland have funds available to assist with travel costs
NIH SUB-STUDY Rituximab to Treat Dermatomyositis and Polymyositis
This study is currently recruiting patients
Sponsored by National Institute of Environmental Health Sciences NIEHS
Information provided by National Institutes of Health Clinical Center CC
Expected Total Enrollment 30
Study start October 2006
Location and Contact Information Patient Recruitment and Public Liaison Office800 411-1222 prplmailccnihgov Phone 1-866-411-1010
The NIH sub-study will take advantage of the multi-center core RIM trial to identify changes in gene expression patterns in muscle skin and peripheral blood and the imaging features and immunopathology of muscle skin and peripheral cells before week 0 and after week 16 therapy These changes will also be correlated with the large number of clinical laboratory and research variables already planned to be collected in the core RIM Study Furthermore knowing specifically which gene expression patterns are altered in resistant patients before rituximab and which are changed after rituximab therapy - in conjunction with flow cytometry of peripheral cells and immunopathology of the tissues - will help in understanding more about the pathogenesis of myositis and the possible contribution of B lymphocytes and their subsets
Patients with dermatomyositis and polymyositis who meet the inclusionexclusion criteria for the core RIM trial may be eligible for this sub-study The following procedures will be conducted in addition to the core RIM trial procedures during the 13 clinic visits over a period of 44 weeks
Weeks 0 16 Muscle and skin biopsy adult only Small samples of muscle and skin tissue will be surgically removed for examination under a microscope
Weeks 0 8 16 44 Skin evaluation and photography The effect of the disease on the skin will be thoroughly evaluated and photographs of any rashes and of the skin around the nails will be taken
Weeks 0 8 16 44 Magnetic resonance imaging MRI All participants will have MRI scans of the skin and of the muscle in the legs Adults will also have an MRI to examine blood flow in the muscle
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 |
|---|---|---|---|
| HHSN26420042273C | US NIH GrantContract | None | httpsreporternihgovquickSearch5R01AR061298-02 |
| 5R01AR061298-02 | NIH | None | None |