Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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patients entered the trial in mild-moderate flare, were treated with depomedrol, and any background immune suppressants withdrawn.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entry on various medications can be compared to biomarkers after steroid efficacy with background immune suppressants withdrawn.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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00987831
The ClinicalTrials.gov registry entry for NCT00987831 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 379-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (58% lower). The listed sponsor is Oklahoma Medical Research Foundation, which has 12 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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
Similar trials for Systemic Lupus Erythematosus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)
RECRUITING · Phase 1
-
A Study of NKX019, a CD19 CAR NK Cell Therapy, in Subjects With Systemic Lupus Erythematosus
RECRUITING · Phase 1
-
REACT-01: Reversing Autoimmunity Through Cell Therapy
RECRUITING · Phase 1
-
Alnuctamab for Refractory SLE (LATTE Study)
RECRUITING · Phase 1
-
BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus
RECRUITING · Phase 1
-
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.