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NCT01085084 · ClinicalTrials.gov registry record · Phase 2

A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis

A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 2
Development phase
82
Enrollment target

NCT01085084: Completed Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT01085084 is a Phase 2 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01085084, a Phase 2 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 2
Development phase
82 participants
Enrollment target

Study Summary

The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams \[mg\] and 1 mg) in participants with active lupus arthritis. 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

Interventions

  • DRUG Placebo
  • DRUG Laquinimod

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2010-10-04
Est. Completion 2012-11-12
Phase Phase 2

What the finished NCT01085084 record still lists

NCT01085084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01085084 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01085084 about?

NCT01085084 is a clinical study titled "A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis". The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams \[mg\] and 1 mg) in participants with active lupus arthritis. Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceut...

What is the current status of trial NCT01085084?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2010-10-04. Estimated completion is 2012-11-12.

What interventions are being tested in trial NCT01085084?

The interventions under investigation include: Placebo (DRUG), Laquinimod (DRUG).

Who is sponsoring clinical trial NCT01085084?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01085084's enrollment target sits among peer trials

82 830th of 2000 higher than 1,167 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

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Source: ClinicalTrials.gov NCT01085084, the US trial registry maintained by the National Library of Medicine. NCT01085084 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.