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PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

NCT01162681 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 547

Last updated 2014-03-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease

Conditions

Interventions

DRUG

A-623

High dose given subcutaneously once a week for up to 52 weeks

DRUG

A-623

Low dose given subcutaneously once a week for up to 52 weeks

DRUG

A-623

High dose given subcutaneously once every 4 weeks for up to 52 weeks

OTHER

Placebo Comparator

Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks

Sponsors & Collaborators

  • Anthera Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

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

Study Locations

More Related Trials

Entities

Diseases

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 NCT01162681 on ClinicalTrials.gov