Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418132
Status:
TERMINATED
Last Update Posted:
2016-03-11
First Post:
2007-01-03
Brief Title:
Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
T Cell Immunity in Collagen Biosynthesis of Scleroderma
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated early due to difficulties in subject recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Progressive systemic sclerosis SSc is an immune-based disease that causes abnormal connective tissue growth of the skin and internal organs At this point there are no effective therapies for treating SSc Thalidomide is a medication that has been shown to stimulate an immune response that reduces the bodys synthesis of collagen the main component of connective tissue This study will determine the effectiveness of thalidomide in treating adults with SSc
Detailed Description:
Progressive systemic sclerosis SSc also known as scleroderma is a disease of the bodys connective tissue It is characterized by fibrosis of the skin or formation of scar-like tissue resulting in progressively increased restriction of joint range of motion Fibrosis of internal organs also occurs leading to irregular heart rhythms acid reflux and respiratory problems Unfortunately no therapies have been developed to effectively treat SSc
The disease is believed to be an immunological disorder that affects T-helper type 2 Th2 cells which stimulate the production of antibodies and interleukin-4 IL-4 a protein with profibrotic properties T-helper type 1 Th1 cells produce interferon-γ IFN-γ a protein that prevents fibroblast production of collagen a primary component of the bodys connective tissue It is possible that shifting the diseases target from the Th2 cells to the Th1 cells may decrease collagen production and thereby reduce fibrosis Thalidomide is an immune modulatory drug that has been shown to stimulate production of Th1 cells This study will evaluate the effectiveness of thalidomide in treating adults with SSc
Following screening procedures participants in this 48-week double-blind study will be randomly assigned to receive placebo or thalidomide at a dose of 50 mgday The thalidomide dose will be increased to 100 mgday at Week 2 then to 200 mgday at Week 4 and finally to 300 mgday at Week 6 Participants who experience dose intolerance will immediately switch to the previously tolerated dose Inpatient hospital visits lasting 2 days will occur at the beginning of the study before starting thalidomide treatment and at Weeks 16 and 48 Assessments and procedures at these visits will include blood and urine collection a physical exam a chest X-ray an electrocardiogram a skin biopsy and various questionnaires Outpatient study visits will occur at Weeks 2 4 6 8 12 18 20 and then every 4 weeks until Week 44 Assessments will include measures of immune function clinical disease hypothalamic-pituitary-adrenal axis and safety Following the Week 48 inpatient visit thalidomide will be tapered off over a 2-week period for all participants
The disease is believed to be an immunological disorder that affects T-helper type 2 Th2 cells which stimulate the production of antibodies and interleukin-4 IL-4 a protein with profibrotic properties T-helper type 1 Th1 cells produce interferon-γ IFN-γ a protein that prevents fibroblast production of collagen a primary component of the bodys connective tissue It is possible that shifting the diseases target from the Th2 cells to the Th1 cells may decrease collagen production and thereby reduce fibrosis Thalidomide is an immune modulatory drug that has been shown to stimulate production of Th1 cells This study will evaluate the effectiveness of thalidomide in treating adults with SSc
Following screening procedures participants in this 48-week double-blind study will be randomly assigned to receive placebo or thalidomide at a dose of 50 mgday The thalidomide dose will be increased to 100 mgday at Week 2 then to 200 mgday at Week 4 and finally to 300 mgday at Week 6 Participants who experience dose intolerance will immediately switch to the previously tolerated dose Inpatient hospital visits lasting 2 days will occur at the beginning of the study before starting thalidomide treatment and at Weeks 16 and 48 Assessments and procedures at these visits will include blood and urine collection a physical exam a chest X-ray an electrocardiogram a skin biopsy and various questionnaires Outpatient study visits will occur at Weeks 2 4 6 8 12 18 20 and then every 4 weeks until Week 44 Assessments will include measures of immune function clinical disease hypothalamic-pituitary-adrenal axis and safety Following the Week 48 inpatient visit thalidomide will be tapered off over a 2-week period for all participants
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 |
|---|---|---|---|
| K23AR002187 | NIH | None | httpsreporternihgovquickSearchK23AR002187 |