A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

NCT01305746 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2014-02-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.

Conditions

Interventions

DRUG

A-623

High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

DRUG

A-623

Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

DRUG

A-623

High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study

Sponsors & Collaborators

  • Anthera Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-07-31
Completion
2013-10-31

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • Colombia
  • Hong Kong
  • India
  • Mexico
  • Peru
  • Philippines
  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305746 on ClinicalTrials.gov