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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 May 2023 |
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Main ID: |
NCT02523092 |
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Date of registration:
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10/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Use of CXCL9 as a Biomarker of Acthar Efficacy
Acthar |
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Scientific title:
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Use of CXCL9 as a Biomarker of Acthar Efficacy |
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Date of first enrolment:
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November 3, 2022 |
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Target sample size:
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14 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02523092 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Laura Koth, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Name:
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Laura Koth, MD |
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Address:
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Telephone:
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(415) 514-4369 |
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Email:
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Laura.Koth@ucsf.edu |
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Affiliation:
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Name:
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Laura Koth, MD |
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Address:
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Telephone:
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415-514-4369 |
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Email:
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laura.koth@ucsf.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Biopsy-proven diagnosis of sarcoidosis with demonstrated pulmonary involvement
- Refractoriness to or intolerance of immunosuppressive agents like prednisone or
methotrexate
Exclusion Criteria:
- Smoking
- Cancer
- Chronic infections (e.g. tuberculosis, viral, fungal, bacterial)
- Inflammatory conditions
- Coexisting lung disease
- Congestive heart failure
- Uncontrolled hypertension
- Recent surgery
- Active peptic ulcers
- Osteoporosis
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sarcoidosis
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Intervention(s)
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Drug: Acthar gel
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Primary Outcome(s)
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Decrease in blood CXCL9 levels by 50%
[Time Frame: within 6 months]
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Secondary Outcome(s)
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Improvement in dyspnea score
[Time Frame: within 6 months]
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Improvement in FVC by 5% of predicted
[Time Frame: within 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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