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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03247686 |
Date of registration:
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03/08/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
RSLV-132 |
Scientific title:
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A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome |
Date of first enrolment:
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February 1, 2017 |
Target sample size:
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28 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03247686 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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James Posada, Ph.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Resolve Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Meet 4 of 6 criteria of 2002 American-European Consensus Group (AECG) criteria for
Primary Sjogren's Syndrome
2. Presence of anti Ro autoantibodies
3. Presence of interferon signature
Exclusion Criteria:
1. Use fo hydroxychloroquine within 30 days of baseline
2. Use of cyclophosphamide within 180 days of baseline
3. Use of oral corticosteroids greater than 10 mg/day
4. Known IgG4-related disease
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sjogren's Syndrome
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Intervention(s)
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Drug: Placebo
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Drug: RSLV-132
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Primary Outcome(s)
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blood cell gene expression
[Time Frame: Day 99]
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Secondary Outcome(s)
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European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI).
[Time Frame: Day 99]
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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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