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A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus

NCT01240694 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2022-12-30

Study results available
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Summary

The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at least Visit 8 (Week 24 of that study).

Conditions

Interventions

DRUG

CEP-33457

CEP-33457 will be administered subcutaneously per dose specified in the arm description.

Sponsors & Collaborators

  • Cephalon, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-12-09
Primary Completion
2012-06-14
Completion
2012-06-14

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Poland
  • Portugal
  • Spain
  • Ukraine
  • United Kingdom

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 NCT01240694 on ClinicalTrials.gov