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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).
This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of an intravenous treatment regimen of two doses of anifrolumab versus placebo in subjects with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. The study will be performed in adult subjects aged 18 to 70 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anifrolumab - higher dose | Experimental | Anifrolumab |
|
| Placebo | Placebo Comparator | Placebo |
|
| Anifrolumab - lower dose | Experimental | Anifrolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anifrolumab | Biological | Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Original Analysis With Restricted Medication Rules) | SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) No new organ systems affected, defined by 1 or more British Isles Lupus Assessment Group (BILAG-2004) A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Original Analysis With Restricted Medication Rules) | SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold. |
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Inclusion Criteria:
Aged 18 through 70 years at the time of screening
Diagnosis of paediatric or adult SLE with a diagnosis of SLE according to the ACR 1982 revised criteria ≥24 weeks prior to signing the Informed Consent form (ICF)
Currently receiving at least 1 of the following:
(i) Azathioprine ≤200 mg/day (ii) Antimalarial (eg, chloroquine, hydroxychloroquine, quinacrine) (iii) Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day (iv) Oral, subcutaneous (SC), or intramuscular methotrexate ≤25 mg/week (v) Mizoribine ≤150 mg/day
Fulfils at least 4 of the 11 ACR modified 1982 classification criteria for SLE, at least 1 of which must be:
At Screening, Disease Activity Adjudication Group confirmation of:
SLEDAI-2K Criteria: SLEDAI-2K score ≥6 points and "Clinical" SLEDAI-2K score ≥4 points. The "Clinical" SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures.
Must not have active or latent TB on either chest radiograph or by quantiferon gold test
Day 1 "Clinical" SLEDAI-2K score ≥4 points
OCS dose stable for at least 2 weeks prior to randomisation
Stable SLE SOC treatment at the time of randomisation
Women of child-bearing potential must have a negative serum β-hCG test and negative urine pregnancy test at randomisation (Day 1) prior to administration of investigational product
Exclusion Criteria:
Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater
Receipt of any of the following:
(a) Intra-articular, intramuscular or IV glucocorticosteroids within 6 weeks prior to Day 1
History of, or current diagnosis of, a clinically significant non SLE-related vasculitis syndrome.
Active severe or unstable neuropsychiatric SLE
Active severe SLE-driven renal disease
Diagnosis (within 1 year of signing the ICF) of mixed connective tissue disease or any history of overlap syndromes of SLE or SSc.
History of, or current, inflammatory joint or skin disease other than SLE
History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than 2 weeks within the last 24 weeks prior to signing the ICF
Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at screening. Subjects refusing HIV testing during the screening period will not be eligible for study participation
Confirmed positive test for hepatitis B or hepatitis C
Any severe herpes infection at any time prior to Week 0 (Day 1)
Opportunistic infection requiring hospitalisation or intravenous antimicrobial treatment within 3 years prior to randomization
History of cancer, apart from:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert Hutman, MD | Medical Science Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35233 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41144892 | Derived | Brunner HI, Cody EM, Devarajan P, Huang B, Chen C, Sinibaldi D, Ramaswamy M, Knagenhjelm J, Jones F, Brohawn PZ, Tummala R, Lindholm C, White WI. The Renal Activity Index for Lupus Identifies Active Renal Disease and Treatment Response in Adult Patients With Systemic Lupus Erythematosus and Lupus Nephritis. Arthritis Care Res (Hoboken). 2026 Jun;78(6):723-732. doi: 10.1002/acr.25684. Epub 2026 Feb 23. | |
| 38229377 |
| Label | URL |
|---|---|
| CSP redacted. | View source |
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Participants took part in the trial at 123 sites in 18 countries worldwide.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anifrolumab 150 mg | Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
| FG001 | Anifrolumab 300 mg | Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 18, 2016 | Dec 19, 2022 |
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| Placebo | Drug | Placebo IV administration every 4 weeks from Week 0 to Week 48 |
|
| Week 52 |
| Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of ≤7.5 mg/Day in the Sub-group of Participants With Baseline OCS ≥10 mg/Day (Original Analysis With Restricted Medication Rules) | Maintained OCS reduction was defined by meeting all the following criteria: Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold. | Week 52 |
| Number of Participants With a ≥50% Reduction in CLASI Activity Score at Week 12 in the Sub-group of Participants With Baseline CLASI Activity Score ≥10 (Original Analysis With Restricted Medication Rules) | 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score compared to baseline was defined by meeting all of the following criteria: Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold before assessment. | Week 12 |
| Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 (SRI[4]) at Week 24 (Original Analysis With Restricted Medication Rules) | SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified threshold. | Week 24 |
| Annualized Flare Rate | A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment. | Baseline to Week 52 |
| Number of Participants Who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Original Analysis With Restricted Medication Rules) | A BICLA responder was achieved if all of the following criteria was met: All criteria related to SRI(4) (please see primary endpoint) plus: Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by 1 or more BILAG-2004 A or 1 or more new BILAG-2004 B item No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment. | Week 52 |
| Number of Participants Reporting One or More Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs. | Baseline to End of Trial (Maximum of 60 weeks) |
| Number of Participants Reporting One or More Adverse Events of Special Interest (AESI) | An AESI is an AE of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by the Investigator to the Sponsor/Sponsor's delegate. An AESI may be serious or nonserious. The events of interest are serious infections, including non opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, TB (including latent TB), influenza, vasculitis (non-SLE), and MACE (including stroke, MI, or cardiovascular death). AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Baseline to End of Trial (Maximum of 60 weeks) |
| Number of Participants With Markedly Abnormal Vital Signs | Vital signs included oral temperature, blood pressure (BP), pulse rate, and respiratory rate. Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Baseline to End of Trial (Maximum of 60 weeks) |
| Number of Participants With Markedly Abnormal Physical Examinations | Physical examinations included height and weight. Participants were weighed at each study visit and any medically significant changes were reported. Physical examination values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Baseline to End of Trial (Maximum of 60 weeks) |
| Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Scores | ECGs documented the date, time, heart rate, QRS duration, PR interval, RR interval, QT, and corrected QT interval, which were calculated using the Fridericia formula. The investigator judged the overall interpretation as normal or abnormal, and if abnormal it was decided as to whether or not the abnormality was clinically significant or not clinically significant. | Baseline to Week 52 |
| Number of Participants With Mild To Moderate Lupus Flare Evaluated by Modified Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI Flare Index | The modified SELENA flare index was completed by the Investigator or delegated/qualified physician. Assessment of flares were scored in comparison to the participant's previous visit and should only include findings which, in the opinion of the Investigator, are due to systemic lupus erythematosus (SLE) disease activity within that timeframe. Flare was defined as any 1 criterion present in either the Mild/Moderate Flare or Severe Flare categories. Number of flares were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Baseline to End of Trial (Maximum of 60 weeks) |
| Number of Participants With Markedly Abnormal Laboratory Tests | Laboratory tests were collected at central clinical laboratories and included hematology, serum chemistry and urinalysis tests. Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Baseline to End of Trial (Maximum of 60 weeks) |
| Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior was defined as the number of participants who answered "yes" at any time during the treatment period (Baseline to Week 52) to one of the 10 categories: Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide | Baseline to Week 52 |
| Change From Baseline in Personal Health Questionnaire Depression Scale-8 (PHQ-8) Score | PHQ-8 is a 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQ-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms. A negative change from baseline score indicates improvement in symptoms. | Baseline to Week 52 |
| El Cajon |
| California |
| 91942-3191 |
| United States |
| Research Site | La Jolla | California | 92037-0706 | United States |
| Research Site | Los Alamitos | California | 90720 | United States |
| Research Site | Thousand Oaks | California | 91360 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Aventura | Florida | 33180 | United States |
| Research Site | Miami | Florida | 33136 | United States |
| Research Site | Orlando | Florida | 32804 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Ormond Beach | Florida | 32174 | United States |
| Research Site | Plantation | Florida | 33324 | United States |
| Research Site | Tampa | Florida | 33614 | United States |
| Research Site | Vero Beach | Florida | 32960 | United States |
| Research Site | Decatur | Georgia | 30033 | United States |
| Research Site | Lawrenceville | Georgia | 30046 | United States |
| Research Site | Marietta | Georgia | 30060 | United States |
| Research Site | Boise | Idaho | 83712 | United States |
| Research Site | Idaho Falls | Idaho | 83404 | United States |
| Research Site | Baton Rouge | Louisiana | 70809 | United States |
| Research Site | Hagerstown | Maryland | 21502 | United States |
| Research Site | Hagerstown | Maryland | 21740 | United States |
| Research Site | Grand Rapids | Michigan | 49546 | United States |
| Research Site | Minneapolis | Minnesota | 55455-0341 | United States |
| Research Site | Nashua | New Hampshire | 03060 | United States |
| Research Site | Freehold | New Jersey | 07728 | United States |
| Research Site | Great Neck | New York | 11021 | United States |
| Research Site | New Hyde Park | New York | 11042 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Charlotte | North Carolina | 28210 | United States |
| Research Site | Raleigh | North Carolina | 27617 | United States |
| Research Site | Cleveland | Ohio | 44109 | United States |
| Research Site | Middleburg Heights | Ohio | 44130 | United States |
| Research Site | Oklahoma City | Oklahoma | 73101 | United States |
| Research Site | Tulsa | Oklahoma | 74104 | United States |
| Research Site | Philadelphia | Pennsylvania | 19140 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15224 | United States |
| Research Site | Wyomissing | Pennsylvania | 19610 | United States |
| Research Site | Charleston | South Carolina | 29406 | United States |
| Research Site | Charleston | South Carolina | 29407 | United States |
| Research Site | Charleston | South Carolina | 29425 | United States |
| Research Site | Jackson | Tennessee | 38305 | United States |
| Research Site | Memphis | Tennessee | 38119 | United States |
| Research Site | Amarillo | Texas | 79124 | United States |
| Research Site | Austin | Texas | 78731 | United States |
| Research Site | Austin | Texas | 78745 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Houston | Texas | 77074 | United States |
| Research Site | Houston | Texas | 77099 | United States |
| Research Site | Mesquite | Texas | 75150 | United States |
| Research Site | San Antonio | Texas | 78232 | United States |
| Research Site | Glendale | Wisconsin | 53217 | United States |
| Research Site | Córdoba | X5004AUL | Argentina |
| Research Site | San Miguel de Tucumán | T4000AXL | Argentina |
| Research Site | Fitzroy | 3065 | Australia |
| Research Site | Kogarah | 2217 | Australia |
| Research Site | St Leonards | 2065 | Australia |
| Research Site | Belo Horizonte | 30150-221 | Brazil |
| Research Site | Juiz de Fora | 36010-570 | Brazil |
| Research Site | Porto Alegre | 90560-030 | Brazil |
| Research Site | Salvador | 40150-150 | Brazil |
| Research Site | Osorno | 5311092 | Chile |
| Research Site | Santiago | 8320000 | Chile |
| Research Site | Viña del Mar | 2520997 | Chile |
| Research Site | Armenia | 630004 | Colombia |
| Research Site | Barranquilla | 0 | Colombia |
| Research Site | Bogotá | 110221 | Colombia |
| Research Site | Bogotá | 111211 | Colombia |
| Research Site | Bucaramanga | 680003 | Colombia |
| Research Site | Medellín | 050021 | Colombia |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Cologne | 50937 | Germany |
| Research Site | Dessau-RoBlau | 06847 | Germany |
| Research Site | Frankfurt am Main | 60528 | Germany |
| Research Site | Göttingen | 37075 | Germany |
| Research Site | Kirchheim | 73230 | Germany |
| Research Site | Budapest | 1097 | Hungary |
| Research Site | Debrecen | 4032 | Hungary |
| Research Site | Szeged | 6725 | Hungary |
| Research Site | Zalaegerszeg | 8900 | Hungary |
| Research Site | Haifa | 31048 | Israel |
| Research Site | Haifa | 3109601 | Israel |
| Research Site | Jerusalem | 9122001 | Israel |
| Research Site | Kfar Saba | 49281 | Israel |
| Research Site | Petah Tikva | 49100 | Israel |
| Research Site | Tel Aviv | 64239 | Israel |
| Research Site | Milan | 20132 | Italy |
| Research Site | Milan | 20157 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Hamilton | 3204 | New Zealand |
| Research Site | Wellington | 6021 | New Zealand |
| Research Site | Arequipa | 54 | Peru |
| Research Site | Lima | 15023 | Peru |
| Research Site | Lima | 15033 | Peru |
| Research Site | Lima | 15046 | Peru |
| Research Site | Lima | 15073 | Peru |
| Research Site | Lima | LIMA 01 | Peru |
| Research Site | Lima | LIMA 31 | Peru |
| Research Site | Bialystok | 15-297 | Poland |
| Research Site | Bydgoszcz | 85-168 | Poland |
| Research Site | Elblag | 82-300 | Poland |
| Research Site | Krakow | 31-011 | Poland |
| Research Site | Lublin | 20-582 | Poland |
| Research Site | Nadarzyn | 05-830 | Poland |
| Research Site | Poznan | 60-773 | Poland |
| Research Site | Poznan | 61-397 | Poland |
| Research Site | Sosnowiec | 41-200 | Poland |
| Research Site | Starachowice | 27-200 | Poland |
| Research Site | Szczecin | 71-252 | Poland |
| Research Site | Ustroń | 43-450 | Poland |
| Research Site | Warsaw | 02-118 | Poland |
| Research Site | Warsaw | 50-088 | Poland |
| Research Site | Brasov | 500283 | Romania |
| Research Site | Bucharest | 010584 | Romania |
| Research Site | Bucharest | 011172 | Romania |
| Research Site | Bucharest | 020475 | Romania |
| Research Site | Cluj-Napoca | 400006 | Romania |
| Research Site | Galati | 800578 | Romania |
| Research Site | Tg Mures | 540136 | Romania |
| Research Site | Daejeon | 301-721 | South Korea |
| Research Site | Gwangju | 61469 | South Korea |
| Research Site | Jeonju | 54907 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 150-713 | South Korea |
| Research Site | Suwon | 61469 | South Korea |
| Research Site | Kaohsiung Hsien | 83342 | Taiwan |
| Research Site | Taichung | 404 | Taiwan |
| Research Site | Taichung | 40705 | Taiwan |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Kiev | 03680 | Ukraine |
| Research Site | Kyiv | 01601 | Ukraine |
| Research Site | Kyiv | 02002 | Ukraine |
| Research Site | Lviv | 79010 | Ukraine |
| Research Site | Lviv | 79011 | Ukraine |
| Research Site | Ternopil | 46002 | Ukraine |
| Research Site | Uzhhorod | 88000 | Ukraine |
| Research Site | Vinnytsia | 21018 | Ukraine |
| Research Site | Zaporizhzhia | 69600 | Ukraine |
| Research Site | Brighton | BN2 5BE | United Kingdom |
| Research Site | Doncaster | DN2 5LT | United Kingdom |
| Research Site | Leeds | LS7 4SA | United Kingdom |
| Research Site | London | SE1 2PR | United Kingdom |
| Research Site | Manchester | M13 9WL | United Kingdom |
| Research Site | Romford | RM7 0AG | United Kingdom |
| Research Site | Staffordshire | WS11 5XY | United Kingdom |
| Derived |
| Furie RA, Morand EF, Bruce IN, Manzi S, Kalunian KC, Vital EM, Lawrence Ford T, Gupta R, Hiepe F, Santiago M, Brohawn PZ, Berglind A, Tummala R; TULIP-1 study investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019 Dec;1(4):e208-e219. doi: 10.1016/S2665-9913(19)30076-1. Epub 2019 Nov 11. |
| 36690388 | Derived | Morand EF, Abreu G, Furie RA, Golder V, Tummala R. Lupus low disease activity state attainment in the phase 3 TULIP trials of anifrolumab in active systemic lupus erythematosus. Ann Rheum Dis. 2023 May;82(5):639-645. doi: 10.1136/ard-2022-222748. Epub 2023 Jan 23. |
| 36018235 | Derived | Bruce IN, van Vollenhoven RF, Morand EF, Furie RA, Manzi S, White WB, Abreu G, Tummala R. Sustained glucocorticoid tapering in the phase 3 trials of anifrolumab: a post hoc analysis of the TULIP-1 and TULIP-2 trials. Rheumatology (Oxford). 2023 Apr 3;62(4):1526-1534. doi: 10.1093/rheumatology/keac491. |
| 35580976 | Derived | Bruce IN, Furie RA, Morand EF, Manzi S, Tanaka Y, Kalunian KC, Merrill JT, Puzio P, Maho E, Kleoudis C, Albulescu M, Hultquist M, Tummala R. Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials. Ann Rheum Dis. 2022 Jul;81(7):962-969. doi: 10.1136/annrheumdis-2021-221847. Epub 2022 May 17. |
| 35338035 | Derived | Vital EM, Merrill JT, Morand EF, Furie RA, Bruce IN, Tanaka Y, Manzi S, Kalunian KC, Kalyani RN, Streicher K, Abreu G, Tummala R. Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials. Ann Rheum Dis. 2022 Jul;81(7):951-961. doi: 10.1136/annrheumdis-2021-221425. Epub 2022 Mar 25. |
| 35157371 | Derived | Loncharich MF, Anderson CW. Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval. ACR Open Rheumatol. 2022 Jun;4(6):486-491. doi: 10.1002/acr2.11414. Epub 2022 Feb 14. |
| 34528084 | Derived | Chia YL, Zhang J, Tummala R, Rouse T, Furie RA, Morand EF. Relationship of anifrolumab pharmacokinetics with efficacy and safety in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2022 May 5;61(5):1900-1910. doi: 10.1093/rheumatology/keab704. |
| 33977796 | Derived | Furie R, Morand EF, Askanase AD, Vital EM, Merrill JT, Kalyani RN, Abreu G, Pineda L, Tummala R. Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus. Lupus. 2021 Jul;30(8):1254-1263. doi: 10.1177/09612033211014267. Epub 2021 May 12. |
| 33913260 | Derived | Furie R, Morand EF, Bruce IN, Isenberg D, van Vollenhoven R, Abreu G, Pineda L, Tummala R. What Does It Mean to Be a British Isles Lupus Assessment Group-Based Composite Lupus Assessment Responder? Post Hoc Analysis of Two Phase III Trials. Arthritis Rheumatol. 2021 Nov;73(11):2059-2068. doi: 10.1002/art.41778. Epub 2021 Sep 22. |
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
| SAP redacted. | View source |
| FG002 | Placebo | Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
| Participants Who Completed Week 52 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set - all randomized participants who received at least one dose of investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Anifrolumab 150 mg | Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
| BG001 | Anifrolumab 300 mg | Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
| BG002 | Placebo | Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Full analysis set - all randomized participants who received at least one dose of investigational product. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Full analysis set - all randomized participants who received at least one dose of investigational product. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Full analysis set - all randomized participants who received at least one dose of investigational product. | Count of Participants | Participants |
| |||||||||||||||
| Height | Full analysis set - all randomized participants who received at least one dose of investigational product. | Mean | Standard Deviation | cm |
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| Weight | Full analysis set - all randomized participants who received at least one dose of investigational product. | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | Full analysis set - all randomized participants who received at least one dose of investigational product. | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Original Analysis With Restricted Medication Rules) | SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) No new organ systems affected, defined by 1 or more British Isles Lupus Assessment Group (BILAG-2004) A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold. | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Week 52 |
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| Post-Hoc | Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Post-Hoc Analysis With Revised Restricted Medication Rules) | SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in lupus disease activity. Worsening defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc allowed threshold. Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints. | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Original Analysis With Restricted Medication Rules) | SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold. | All participants who received investigational product with non-missing baseline measurements, and high IFN test results. | Posted | Count of Participants | Participants | Week 52 |
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| Post-Hoc | Number of Participants Who Achieved an Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Post-Hoc Analysis With Revised Restricted Medication Rules) | SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in lupus disease activity. Worsening defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold. Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints. | All participants who received investigational product with non-missing baseline measurements, and high IFN test results. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of ≤7.5 mg/Day in the Sub-group of Participants With Baseline OCS ≥10 mg/Day (Original Analysis With Restricted Medication Rules) | Maintained OCS reduction was defined by meeting all the following criteria: Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold. | All participants who received investigational product, who had a baseline OCS ≥10 mg/day, and had non-missing baseline measurements. | Posted | Count of Participants | Participants | Week 52 |
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| Post-Hoc | Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of ≤7.5 mg/Day in the Sub-group of Participants With Baseline OCS ≥10 mg/Day (Post-Hoc Analysis With Revised Restricted Medication Rules) | Maintained OCS reduction was defined by meeting all of the following criteria: Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold. Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medication confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints. | All participants who received investigational product, who had a baseline OCS ≥10 mg/day, and had non-missing baseline measurements. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Number of Participants With a ≥50% Reduction in CLASI Activity Score at Week 12 in the Sub-group of Participants With Baseline CLASI Activity Score ≥10 (Original Analysis With Restricted Medication Rules) | 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score compared to baseline was defined by meeting all of the following criteria: Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold before assessment. | All participants who received investigational product, had a baseline CLASI Activity Score ≥10, and had non-missing baseline measurements. | Posted | Count of Participants | Participants | Week 12 |
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| Post-Hoc | Number of Participants With a ≥50% Reduction in CLASI Activity Score at Week 12 in the Sub-group of Participants With Baseline CLASI Activity Score ≥10 (Post-Hoc Analysis With Revised Restricted Medication Rules) | 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score compared to baseline was defined by meeting all the following criteria: Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment. Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medication confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints. | All participants who received investigational product, had a baseline CLASI Activity Score ≥10, and had non-missing baseline measurements. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 (SRI[4]) at Week 24 (Original Analysis With Restricted Medication Rules) | SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified threshold. | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Week 24 |
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| Post-Hoc | Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 (SRI[4]) at Week 24 (Post-Hoc Analysis With Revised Restricted Medication Rules) | SRI(4) was defined as meeting all of the following criteria: Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in lupus disease activity. Worsening defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc allowed threshold. Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints. | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Annualized Flare Rate | A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment. | Full analysis set - all randomized participants who received investigational product with non-missing baseline measurements. | Posted | Number | Annualized flare rate ratio | Baseline to Week 52 |
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| Secondary | Number of Participants Who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Original Analysis With Restricted Medication Rules) | A BICLA responder was achieved if all of the following criteria was met: All criteria related to SRI(4) (please see primary endpoint) plus: Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by 1 or more BILAG-2004 A or 1 or more new BILAG-2004 B item No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment. | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Week 52 |
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| Post-Hoc | Number of Participants Who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Post-Hoc Analysis With Revised Restricted Medication Rules) | A BICLA responder was achieved if all of the following criteria was met: All criteria related to SRI(4) (please see primary endpoint) plus: Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by 1 or more BILAG-2004 A or 1 or more new BILAG-2004 B item No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment. Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints. | Full analysis set - all randomized participants who received at least one dose of investigation product. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Number of Participants Reporting One or More Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs. | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Baseline to End of Trial (Maximum of 60 weeks) |
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| Secondary | Number of Participants Reporting One or More Adverse Events of Special Interest (AESI) | An AESI is an AE of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by the Investigator to the Sponsor/Sponsor's delegate. An AESI may be serious or nonserious. The events of interest are serious infections, including non opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, TB (including latent TB), influenza, vasculitis (non-SLE), and MACE (including stroke, MI, or cardiovascular death). AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Baseline to End of Trial (Maximum of 60 weeks) |
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| Secondary | Number of Participants With Markedly Abnormal Vital Signs | Vital signs included oral temperature, blood pressure (BP), pulse rate, and respiratory rate. Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Baseline to End of Trial (Maximum of 60 weeks) |
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| Secondary | Number of Participants With Markedly Abnormal Physical Examinations | Physical examinations included height and weight. Participants were weighed at each study visit and any medically significant changes were reported. Physical examination values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Baseline to End of Trial (Maximum of 60 weeks) |
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| Secondary | Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Scores | ECGs documented the date, time, heart rate, QRS duration, PR interval, RR interval, QT, and corrected QT interval, which were calculated using the Fridericia formula. The investigator judged the overall interpretation as normal or abnormal, and if abnormal it was decided as to whether or not the abnormality was clinically significant or not clinically significant. | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Number of Participants With Mild To Moderate Lupus Flare Evaluated by Modified Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI Flare Index | The modified SELENA flare index was completed by the Investigator or delegated/qualified physician. Assessment of flares were scored in comparison to the participant's previous visit and should only include findings which, in the opinion of the Investigator, are due to systemic lupus erythematosus (SLE) disease activity within that timeframe. Flare was defined as any 1 criterion present in either the Mild/Moderate Flare or Severe Flare categories. Number of flares were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Baseline to End of Trial (Maximum of 60 weeks) |
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| Secondary | Number of Participants With Markedly Abnormal Laboratory Tests | Laboratory tests were collected at central clinical laboratories and included hematology, serum chemistry and urinalysis tests. Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Baseline to End of Trial (Maximum of 60 weeks) |
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| Secondary | Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior was defined as the number of participants who answered "yes" at any time during the treatment period (Baseline to Week 52) to one of the 10 categories: Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide | Full analysis set - all randomized participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | Baseline to Week 52 |
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| Secondary | Change From Baseline in Personal Health Questionnaire Depression Scale-8 (PHQ-8) Score | PHQ-8 is a 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQ-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms. A negative change from baseline score indicates improvement in symptoms. | All participants who received study drug with non-missing baseline and week 52 measurements. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline to Week 52 |
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Baseline to End of Trial (Maximum of 60 weeks post first dose)
AEs were either spontaneously reported by the participant or reported in response to open questions, revealed by observation, or were changes from baseline/deterioration in tests and vital signs that met SAE criteria or led to IP discontinuation. Full analysis set: All participants who had received at least one dose of investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anifrolumab 150 mg | Anifrolumab (150 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) | 0 | 93 | 10 | 93 | 78 | 93 |
| EG001 | Anifrolumab 300 mg | Anifrolumab (300 mg) administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) | 1 | 180 | 27 | 180 | 157 | 180 |
| EG002 | Placebo | Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) | 1 | 184 | 35 | 184 | 141 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Appenicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Genital herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Meningitis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Subcutaneous abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Encephalitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Epididymitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Infectious colitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Otitis media chronic | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Pelvic infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
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| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
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| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
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| Conversion disorder | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Myasthenia gravis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Neuropsychiatric lupus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Ulcerative keratitis | Eye disorders | MedDRA 21.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Raynaud's phenomenon | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Venous thrombosis limb | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Fracture pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Nephritis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Lupus nephritis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
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| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Perirenal haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Steroid withdrawal syndrome | Endocrine disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Leader | AstraZeneca AB | +46317761000 | ClinicalTrialTransparency@astrazeneca.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 20, 2018 | Dec 19, 2022 | SAP_003.pdf |
| ID | Term |
|---|---|
| C582345 | anifrolumab |
Not provided
Not provided
Not provided
| ≥ 18 to < 65 |
|
| ≥ 65 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mean Difference (Final Values) | -2.6 | 2-Sided | 95 | -14.7 | 9.6 | Superiority |
| Placebo |
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
|
|
|
|
|
|
| OG002 | Placebo | Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
|
|
|
|
|
|
| Placebo |
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
|
|
|
|
|
|
| Placebo |
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
|
|
|
|
|
|
| Placebo |
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
|
|
|
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses)
|
|
|
|
|
|
| OG002 | Placebo | Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
|
|
|
|
|
| Placebo |
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 |
| Placebo |
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 |
| Placebo |
Matching placebo administered via an intravenous infusion (IV) every 4 weeks for up to 48 weeks (13 doses) |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|