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NCT01971346 · ClinicalTrials.gov registry record · Phase 4
The Immunological Basis for Treatment Resistance to Anti-TNF Treatments
A Phase 4 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT01971346: Completed Phase 4 study, sponsored by University of Michigan.
NCT01971346 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01971346, a Phase 4 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the relationship between two types of cell signals, type I interferon (IFN) and tumor necrosis factor (TNF), in psoriatic skin prior to and during treatment with etanercept and correlate that information with the degree of the improvement in the psoriasis.
Primary Outcome
A cumulative change in PASI score from baseline to week 12 will be calculated for each patient. The PASI is the industry standard to decrease/eliminate subjectivity in determining psoriasis severity. It is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The severity of plaque characteristics (erythema, thickness and scaling) for body regions (head, upper limbs, trunk and lower limbs) is combined with the degree of plaque i
Interventions
- DRUG etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-03-13 |
| Est. Completion | 2017-11-01 |
| Phase | Phase 4 |
What the finished NCT01971346 record still lists
NCT01971346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which etanercept is the first listed.
NCT01971346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01971346 about?
NCT01971346 is a clinical study titled "The Immunological Basis for Treatment Resistance to Anti-TNF Treatments". The purpose of this study is to determine the relationship between two types of cell signals, type I interferon (IFN) and tumor necrosis factor (TNF), in psoriatic skin prior to and during treatment with etanercept and correlate that information with the degree of the improvement in the psoriasis.
What is the current status of trial NCT01971346?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2014-03-13. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT01971346?
The interventions under investigation include: etanercept (DRUG).
Who is sponsoring clinical trial NCT01971346?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01971346's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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