A Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus

Phase 1

• Conditions: Systemic Lupus Erythematosus; MedDRA version: 18.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-004619-30-BG
• Lead Sponsor: MedImmune, LLC, a wholly owned subsidiary of AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-07
• Study Completion: 2018-07-18
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 218

Inclusion Criteria

Must provide written informed consent
Must have qualified for and completed study CD-IA-MEDI-546-1013
Must be willing to use 2 methods of effective contraception
Must have adequate venous access
Must be willing to forego other forms of experimental treatment
Must be able to complete the study period.
Has adequate reading and writing abilities to comprehend and complete the informed consent,
and all protocol-related subject assessments.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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
-Concomitant medications within the last 12 weeks: Azathioprine greater
than 200mg/day, Mycophenolate mofetil/mycophenolic acid greater than 2.0g/day, oral, sc, or intramuscular methotrexate greater than 25mg/week
- Receipt of a live or attenuated vaccine within 4 weeks of signing the ICF
-Receipt of Bacillus of Calmette and Guerin (BCG) vaccine within 1 year of ICF

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified