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NCT01085097 · ClinicalTrials.gov registry record · Phase 2
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
A Phase 2 study of Lupus Nephritis, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 20
- Study locations
NCT01085097: Completed Phase 2 study of Lupus Nephritis, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01085097 is a Phase 2 study of Lupus Nephritis that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 46 participants, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01085097, a Phase 2 study of Lupus Nephritis, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil \[MMF\] and corticosteroids). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.
Primary Outcome
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of ot
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mycophenolate Mofetil
- DRUG Methylprednisolone
- DRUG Laquinimod
- DRUG Prednisolone/Prednisone
Study Locations (20)
New York
- Teva Investigational Site 1022 - Lake Success
- Teva Investigational Site 1018 - Manhasset
- Teva Investigational Site 1019 - New York
- Teva Investigational Site 1017 - New York
California
- Teva Investigational Site 1024 - La Jolla
- Teva Investigational Site 1028 - Los Angeles
- Teva Investigational Site 1025 - San Leandro
Other
- Teva Investigational Site 3510 - Lille
- Teva Investigational Site 3509 - Paris
- Teva Investigational Site 5006 - Kazan'
Arizona
- Teva Investigational Site 1032 - Phoenix
Maryland
- Teva Investigational Site 1031 - Baltimore
Minnesota
- Teva Investigational Site 1021 - Rochester
North Carolina
- Teva Investigational Site 1020 - Charlotte
Ohio
- Teva Investigational Site 1016 - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2010-09-01 |
| Est. Completion | 2012-10-24 |
| Phase | Phase 2 |
What the finished NCT01085097 record still lists
NCT01085097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01085097 names 20 study sites across 13 states, led by New York, California, Other.
Frequently Asked Questions
What is clinical trial NCT01085097 about?
NCT01085097 is a clinical study titled "A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis". The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil \[M...
What is the current status of trial NCT01085097?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2010-09-01. Estimated completion is 2012-10-24.
What conditions does trial NCT01085097 study?
This clinical trial studies the following conditions: Lupus Nephritis.
What interventions are being tested in trial NCT01085097?
The interventions under investigation include: Placebo (DRUG), Mycophenolate Mofetil (DRUG), Methylprednisolone (DRUG), Laquinimod (DRUG), Prednisolone/Prednisone (DRUG).
Who is sponsoring clinical trial NCT01085097?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01085097 being conducted?
This trial has 20 study locations across Arizona, California, Maryland, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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