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Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus

NCT01405196 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2017-12-19

Study results available
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Summary

The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

BIOLOGICAL

PF-04236921

subcutaneous injection; administered at day 1, weeks 8, 16.

BIOLOGICAL

PF-04236921

subcutaneous injection; administered at day 1, weeks 8, 16.

BIOLOGICAL

PF-04236921

subcutaneous injection; administered at day 1, weeks 8, 16.

BIOLOGICAL

PF-04236921

subcutaneous injection; administered at day 1, weeks 8, 16

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States
  • Argentina
  • Chile
  • Colombia
  • Germany
  • Hungary
  • Moldova
  • Peru
  • Poland
  • Puerto Rico
  • Romania
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

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 NCT01405196 on ClinicalTrials.gov