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NCT03355482 · ClinicalTrials.gov registry record · Phase 2
MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE
A Phase 2 study, sponsored by Oklahoma Medical Research Foundation.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03355482 is a Phase 2 study that was terminated before completion, run by Oklahoma Medical Research Foundation. The registered enrollment target is 9 participants.
The verdict
NCT03355482, a Phase 2 study, was terminated before completion, sponsored by Oklahoma Medical Research Foundation.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is an exploratory evaluation of MRI as a reliable, sensitive, and accurate outcome measure for clinical trials in SLE arthritis. Forty patients with SLE and moderate to severe synovitis (minimum of 3 tender and 3 swollen joints in wrists and hands) will be randomized to new or increased methotrexate therapy plus a single injection of Depomedrol or a matched placebo at baseline. Methotrexate will be injected subcutaneously once per week at ascending doses. The study will evaluate a range of outcomes discernable by MRI at 3 months and 6 months after baseline. We will also compare MRI findings, clinical endpoints, and biomarker changes in patients that were treated with Depomedrol vs. matched placebo at baseline.
Interventions
- DRUG Methylprednisolone
- DRUG Placebos
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-04-10 |
| Est. Completion | 2022-12-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03355482
The ClinicalTrials.gov registry entry for NCT03355482 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oklahoma Medical Research Foundation, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone is the first listed.
NCT03355482 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03355482 about?
NCT03355482 is a clinical study titled "MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE". This is an exploratory evaluation of MRI as a reliable, sensitive, and accurate outcome measure for clinical trials in SLE arthritis. Forty patients with SLE and moderate to severe synovitis (minimum of 3 tender and 3 swollen joints in wrists and hands) will be randomized to new or increased methotr...
What is the current status of trial NCT03355482?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2017-04-10. Estimated completion is 2022-12-16.
What interventions are being tested in trial NCT03355482?
The interventions under investigation include: Methylprednisolone (DRUG), Placebos (DRUG).
Who is sponsoring clinical trial NCT03355482?
This trial is sponsored by Oklahoma Medical Research Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.
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