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NCT02334306 · ClinicalTrials.gov registry record · Phase 2
A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
A Phase 2 study of Primary Sjögren's Syndrome, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 13
- Study locations
NCT02334306: Completed Phase 2 study of Primary Sjögren's Syndrome, sponsored by MedImmune.
NCT02334306 is a Phase 2 study of Primary Sjögren's Syndrome that has completed, run by MedImmune. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). The trial reports 13 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02334306, a Phase 2 study of Primary Sjögren's Syndrome, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 13
- Study locations
Study Summary
A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
Primary Outcome
The European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of 12 organ-specific domains (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological). Each domain is assessed for activity level in 3 or 4 levels (i.e., no, low, moderate,
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL AMG 557/MEDI5872
Study Locations (13)
Other
- Research Site - Brest
- Research Site - Le Kremlin-Bicêtre
- Research Site - Lille
- Research Site - Paris
- Research Site - Paris
- Research Site - Strasbourg
- Research Site - Stockholm
- Research Site - London
- Research Site - Newcastle upon Tyne
- Research Site - Swindon
California
- Research Site - San Francisco
Maryland
- Research Site - Bethesda
Pennsylvania
- Research Site - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-06-08 |
| Est. Completion | 2018-08-13 |
| Phase | Phase 2 |
What the finished NCT02334306 record still lists
NCT02334306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Primary Sjögren's Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02334306 lists 13 locations in 4 states (Other, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT02334306 about?
NCT02334306 is a clinical study titled "A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome". A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
What is the current status of trial NCT02334306?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2015-06-08. Estimated completion is 2018-08-13.
What conditions does trial NCT02334306 study?
This clinical trial studies the following conditions: Primary Sjögren's Syndrome.
What interventions are being tested in trial NCT02334306?
The interventions under investigation include: Placebo (OTHER), AMG 557/MEDI5872 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02334306?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02334306 being conducted?
This trial has 13 study locations across California, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02334306's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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