An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
NCT ID: NCT01753193
Last Updated: 2019-07-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
218 participants
INTERVENTIONAL
2013-03-28
2018-07-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
NCT01438489
A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus
NCT00657189
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
NCT04877691
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
NCT01559090
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
NCT01031836
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Anifrolumab
Participants 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.
Anifrolumab
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anifrolumab
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must have venous access
* Must be willing to forego participation in other clinical trials for SLE.
Exclusion Criteria
* 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
18 Years
68 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedImmune LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
La Palma, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Angeles, California, United States
Research Site
Palm Desert, California, United States
Research Site
Upland, California, United States
Research Site
Ocala, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Stockbridge, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Las Cruces, New Mexico, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Memphis, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Spokane, Washington, United States
Research Site
Rio de Janeiro, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , 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, , Peru
Research Site
Lima, , Peru
Research Site
Bialystok, , Poland
Research Site
Krakow, , Poland
Research Site
Nadarzyn, , Poland
Research Site
Poznan, , Poland
Research Site
Iași, , Romania
Research Site
Gwangju, , South Korea
Research Site
Seodaemun-gu, , South Korea
Research Site
Suwon, , South Korea
Research Site
Chiayi City, , Taiwan
Research Site
Zhongzheng District, , Taiwan
Research Site
Donetsk, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Ternopil, , Ukraine
Research Site
Vinnitsya, , Ukraine
Research Site
Vinnytsia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-004619-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CD-IA-MEDI-546-1145
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.