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An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01753193
Recruitment Status : Active, not recruiting
First Posted : December 20, 2012
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the long-term safety of MEDI-546 in adults with moderate to severe active systemic lupus erythematosus

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Biological: MEDI-546 Phase 2

Detailed Description:
This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) MEDI-546 in adult subjects with moderately-to-severely active systemic lupus erythematosus (SLE). Subjects must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is an Open Label Extension study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus
Actual Study Start Date : March 28, 2013
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MEDI-546
MEDI-546, IV q4wks for 104 weeks
Biological: MEDI-546
MEDI-546, IV q4wks for 104 weeks


Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 3 years ]
    safety and tolerability will be assessed primarily by summarizing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).


Secondary Outcome Measures :
  1. Immunogenicity [ Time Frame: 3 years ]
    Immunogenicity will be measured by laboratory assessments looking for anti-drug antibodies


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be willing to use 2 methods of effective contraception
  • Must have venous access
  • Must be willing to forego participation in other clinical trials for SLE.

Exclusion Criteria:

  • Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
  • Major surgery within 8 weeks before signing ICF
  • Elective major surgery planned during the study period
  • Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day, Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, Oral, SC, or intramuscular methotrexate > 25 mg/week
  • A live or attenuated vaccine within 4 weeks of signing the ICF
  • Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753193


  Show 57 Study Locations
Sponsors and Collaborators
MedImmune LLC
More Information

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01753193     History of Changes
Other Study ID Numbers: CD-IA-MEDI-546-1145
2012-004619-30 ( EudraCT Number )
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. Additional information can be found on astrazenecaclinicaltrials.com.
URL: http://

Keywords provided by MedImmune LLC:
Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases