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NCT00987831 · ClinicalTrials.gov registry record · Phase 1
Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)
A Phase 1 study of Systemic Lupus Erythematosus, sponsored by Oklahoma Medical Research Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 158
- Enrollment target
- 2
- Study locations
NCT00987831: Completed Phase 1 study of Systemic Lupus Erythematosus, sponsored by Oklahoma Medical Research Foundation.
NCT00987831 is a Phase 1 study of Systemic Lupus Erythematosus that has completed, run by Oklahoma Medical Research Foundation. The registered enrollment target is 158 participants, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (58% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00987831, a Phase 1 study of Systemic Lupus Erythematosus, has completed, sponsored by Oklahoma Medical Research Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 158 participants
- Enrollment target
- 2
- Study locations
Study Summary
Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the variable effects on immune homeostasis of the background medications that must be continued, in most study designs, in these flare-prone patients. Purpose of Study: This study was designed to purposefully study a population equivalent to the placebo group of typical trials in SLE. In Group A patients entered the trial in mild-moderate flare, were treated with depomedrol, and any background immune suppressants withdrawn. Biomarkers at entry on various medications can be compared to biomarkers after steroid efficacy with background immune suppressants withdrawn. Depomedrol usually wears off over one to three months. Patients were closely observed, with serial biomarkers drawn at monthly intervals or immediately at the time of a new flare. Those patients developing new flares donated blood samples, were immediately treated as deemed appropriate, exiting the study. Group A was designed for up to 50 patients and recruited a total of 41. An additional group of 62 SLE patients donated blood once without additional interventions in order to increase the power of exploratory cross-sectional biomarker analysis on different immune suppressants (Group B). A control population of matched, healthy individuals donated blood twice for the same biomarker studies to validate these assays (Group C).
Primary Outcome
Group A only: patients on immunosuppressive treatments had them withdrawn at baseline. All patients were allowed up to 160 mg depomedrol at baseline which could be repeated within two weeks up to a total of 4 shots maximum or until satisfactory improvement. Time to flare was calculated from baseline. moderate disease at baseline was defined as up to 3 BILAG B (moderate disease) organ scores, no BILAG A (severe disease) score and a SLEDAI \</= 10. Severe disease required \>3 BILAG B, OR at least
Conditions Studied
Interventions
- OTHER Group B SLE one blood donation
- OTHER Blood drawing only Group C
- DRUG Group A SLE prospective study
Study Locations (2)
Oklahoma
- Oklahoma Medical Research Foundation - Oklahoma City
Pennsylvania
- Pfizer Inc - Collegeville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2009-05 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT00987831 record still lists
NCT00987831 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 3 interventions - of which Group B SLE one blood donation is the first listed.
NCT00987831 reports a single indexed study location in Oklahoma, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00987831 about?
NCT00987831 is a clinical study titled "Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)". Hypothesis: A reason for repeated disappointing outcomes of clinical trials testing targeted immune biologics for lupus may be the heterogeneity of the disease, exacerbated by the variable effects on immune homeostasis of the background medications that must be continued, in most study designs, in t...
What is the current status of trial NCT00987831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2009-05. Estimated completion is 2012-12.
What conditions does trial NCT00987831 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT00987831?
The interventions under investigation include: Group B SLE one blood donation (OTHER), Blood drawing only Group C (OTHER), Group A SLE prospective study (DRUG).
Who is sponsoring clinical trial NCT00987831?
This trial is sponsored by Oklahoma Medical Research Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00987831 being conducted?
This trial has 2 study locations across Oklahoma, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00987831's enrollment target sits among peer trials
158 46th of 99 higher than 54 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus 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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