Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 2 study, sponsored by Oklahoma Medical Research Foundation.
NCT03355482 is a Phase 2 study that was terminated before completion, run by Oklahoma Medical Research Foundation. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
the sum of the MRI synovitis, osteitis and tendinitis scores at 3 months will be compared to baseline by paired t test for those patients with a clinical response to the treatment regimen (defined as\>/= 50% decrease in tender and swollen joints and disease severity scored as BILAG C or D at the 3 month visit). Each MRI parameter will be scored semi-quantitatively according to the OMERACT RA-MRI scoring system (RAMRIS) on a scale of 0-3, with 0=normal, 1=mild, 2=moderate, 3=severe involvement.
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 |
Why NCT03355482 stopped before completion
NCT03355482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone is the first listed.
NCT03355482 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03355482's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI