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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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.

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).

An open-label study to evaluate the long-term safety of MEDI-546, for the treatment of SLE, in adults

This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) anifrolumab in adult participants with moderately-to-severely active SLE. Participants must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.

NCT ID

Patient Level Data

Therapeutic Area

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.

Research Site

A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus

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.

Number of participants with DAEs are reported.

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.

Age Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

As-treated population included all participants who received any dose of study drug in the OLE study.

TEAEs

TESAEs

Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab

The number of participants with positive serum antibodies to anifrolumab at anytime (including baseline) are reported.

As-treated population included all participants who received any dose of study drug in the OLE study. Participants with reportable ADA titer results were analyzed for this outcome measure.

Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab

Median ADA titer in participants with ADA-positive assessments and reportable ADA titer results are reported.

As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.

Anti-Drug Antibodies (ADA) Titer to Anifrolumab

Number of participants with decreased serum concentration of anifrolumab due to ADA-positive results are reported.

Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab

Number of participants with decreased pharmacodynamic response of anifrolumab due to ADA-positive results are reported.

Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab

Baseline

Week 12

Week 24

Week 36

Week 48

Week 60

Week 72

Week 84

Week 96

Week 108

Week 120

Week 132

Week 144

Week 156

Week 160

Week 168

The SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).

Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants

The number of ADA-positive participants with TEAEs and TESAEs are reported.

Number of ADA-positive Participants With TEAEs and TESAEs

Herpes zoster

Drug hypersensitivity

Hypersensitivity

Infusion related reaction

Nausea

Hodgkin's disease

Latent tuberculosis

Hypersensitivity vasculitis

Vasculitis

Number of Participants With Adverse Events of Special Interest (AESIs)

Overall Study

A total of 218 participants were enrolled in this open-label extension (OLE) study.

An open-label study to evaluate the long-term safety of MEDI-546, for the treatment of SLE, in adults

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact