An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus
2 other identifiers
interventional
218
13 countries
57
Brief Summary
The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2013
Longer than P75 for phase_2
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 20, 2012
CompletedStudy Start
First participant enrolled
March 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2018
CompletedResults Posted
Study results publicly available
July 31, 2019
CompletedJuly 31, 2019
July 1, 2019
5.3 years
December 17, 2012
July 11, 2019
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
From first dose of study drug (Day 1) through 168 weeks
Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab
Number of participants with DAEs are reported.
From first dose of study drug (Day 1) through 168 weeks
Number of Participants With Adverse Events of Special Interest (AESIs)
An AESI is scientific and medical concern specific to understanding of the study drug. An AESI may be serious or non-serious. Number of participants with AESIs are reported.
From first dose of study drug (Day 1) through 168 weeks
Secondary Outcomes (6)
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab
Baseline (Pre-dose on Day 1) up to Week 168
Anti-Drug Antibodies (ADA) Titer to Anifrolumab
Baseline (Pre-dose on Day 1) up to Week 168
Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab
Baseline (Pre-dose on Day 1) up to Week 168
Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab
Baseline (Pre-dose on Day 1) up to Week 168
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168
- +1 more secondary outcomes
Study Arms (1)
Anifrolumab
EXPERIMENTALParticipants will receive IV infusion of anifrolumab 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter will receive 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
Interventions
Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 informed consent form (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, subcutaneous, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (57)
Research Site
Birmingham, Alabama, 35294, United States
Research Site
La Palma, California, 90623, United States
Research Site
Long Beach, California, 90806, United States
Research Site
Los Angeles, California, 90095-1670, United States
Research Site
Palm Desert, California, 92260, United States
Research Site
Upland, California, 91786, United States
Research Site
Ocala, Florida, 34474, United States
Research Site
Orlando, Florida, 32806, United States
Research Site
Tampa, Florida, 33614, United States
Research Site
Atlanta, Georgia, 30281, United States
Research Site
Stockbridge, Georgia, 30281, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Indianapolis, Indiana, 46202, United States
Research Site
Las Cruces, New Mexico, 88011, United States
Research Site
New York, New York, 10016, United States
Research Site
Charlotte, North Carolina, 28204, United States
Research Site
Raleigh, North Carolina, 27617, United States
Research Site
Columbus, Ohio, 43203, United States
Research Site
Tulsa, Oklahoma, 74104, United States
Research Site
Memphis, Tennessee, 38119, United States
Research Site
Houston, Texas, 77004, United States
Research Site
Houston, Texas, 77034, United States
Research Site
Spokane, Washington, 99204, United States
Research Site
Rio de Janeiro, 22040-042, Brazil
Research Site
São Paulo, 04032-060, Brazil
Research Site
Plovdiv, 4002, Bulgaria
Research Site
Sofia, 1431, Bulgaria
Research Site
Barranquilla, Colombia
Research Site
Bogotá, Colombia
Research Site
Bucaramanga, Colombia
Research Site
Chía, Colombia
Research Site
Medellín, Colombia
Research Site
Brno, Czechia
Research Site
Prague, Czechia
Research Site
Debrecen, Hungary
Research Site
Guadalajara, Mexico
Research Site
León, Mexico
Research Site
México, Mexico
Research Site
Toluca, Mexico
Research Site
Arequipa, Peru
Research Site
Lima, 15033, Peru
Research Site
Lima, Peru
Research Site
Bialystok, 15-297, Poland
Research Site
Krakow, 31-011, Poland
Research Site
Nadarzyn, 05-830, Poland
Research Site
Poznan, 61-397, Poland
Research Site
Iași, 700661, Romania
Research Site
Gwangju, South Korea
Research Site
Seodaemun-gu, South Korea
Research Site
Suwon, 16499, South Korea
Research Site
Chiayi City, 622, Taiwan
Research Site
Zhongzheng District, Taiwan
Research Site
Donetsk, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Ternopil, Ukraine
Research Site
Vinnitsya, 21029, Ukraine
Research Site
Vinnytsia, 21018, Ukraine
Related Publications (1)
Chatham WW, Furie R, Saxena A, Brohawn P, Schwetje E, Abreu G, Tummala R. Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. Arthritis Rheumatol. 2021 May;73(5):816-825. doi: 10.1002/art.41598. Epub 2021 Mar 24.
PMID: 33225631DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Raj Tummala
- Organization
- MedImmune, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2012
First Posted
December 20, 2012
Study Start
March 28, 2013
Primary Completion
July 18, 2018
Study Completion
July 18, 2018
Last Updated
July 31, 2019
Results First Posted
July 31, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
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.