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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04058028
Registration number
NCT04058028
Ethics application status
Date submitted
30/07/2019
Date registered
15/08/2019
Date last updated
24/09/2024
Titles & IDs
Public title
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
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Scientific title
A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
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Secondary ID [1]
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20170588
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus (SLE)
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rozibafusp Alfa
Treatment: Drugs - Placebo for Rozibafusp Alfa
Experimental: Rozibafusp Alfa, Dose A - Investigational product solution in vial
Experimental: Rozibafusp Alfa, Dose B - Investigational product solution in vial
Experimental: Rozibafusp Alfa, Dose C - Investigational product solution in vial
Placebo comparator: Placebo for Rozibafusp Alfa - Placebo Investigational product solution in vial
Treatment: Drugs: Rozibafusp Alfa
Rozibafusp Alfa will be presented in 5 mL glass vial
Treatment: Drugs: Placebo for Rozibafusp Alfa
Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52
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Assessment method [1]
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SRI-4 response at Week 52 is defined as a = 4-point decrease in the hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score, and no new British Isles Lupus Assessment Group (BILAG) 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in Physician Global Assessment (PGA) (scale 0 to 3), and no use of more than protocol allowed therapies.
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Number of Participants With a SRI-4 Response at Week 24
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Assessment method [1]
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SRI-4 response at Week 24 is defined as a = 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24
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Assessment method [2]
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The BICLA response is defined as: 1. An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A) 2. No new BILAG 2004 A domain score and no \> 1 new BILAG 2004 B domain scores compared with baseline 3. No worsening of the hSLEDAI score from baseline 4. No = 0.3-point deterioration from baseline in PGA 5. No use of more than protocol-allowed therapies 6. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants.
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52
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Assessment method [3]
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LLDAS was defined as meeting all the following conditions: 1. hSLEDAI = 4, with no activity in major organ system (renal, central nervous system \[CNS\], cardiopulmonary, vasculitis, fever) and hemolytic anemia or gastrointestinal activity 2. No new lupus disease activity as compared with the previous assessment 3. PGA = 1 (on a scale of 0 to 3) 4. Current prednisone or equivalent dose of = 7.5 mg/day 5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved treatments, as allowed and specified in the protocol.
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Timepoint [3]
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Week 52
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Secondary outcome [4]
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Number of Participants Who Achieved a BICLA Response at Week 52
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Assessment method [4]
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The BICLA response is defined as: 1. An improvement in baseline BILAG domain scores across all body systems with moderate (domain B) or severe disease activity (domain A) 2. No new BILAG 2004 A domain score and no \> 1 new BILAG 2004 B domain scores compared with baseline 3. No worsening of the hSLEDAI score from baseline 4. No = 0.3-point deterioration from baseline in PGA 5. No use of more than protocol-allowed therapies 6. No disallowed changes in concomitant medications, mainly including increases in corticosteroids, immunosuppressants.
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to = 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose = 10 mg/Day
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Assessment method [5]
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SRI-4 response is defined as a = 4-point decrease in the hSLEDAI score, and no new BILAG 2004 A score, no greater than 1 new BILAG B domain scores compared with baseline, and a less than 0.3-point deterioration from baseline in PGA (scale 0 to 3), and no use of more than protocol allowed therapies. Participants also had to meet a reduction if OCS to = 7.5 mg/day by Week 44 sustained through Week 52.
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Timepoint [5]
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Up to Week 52
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Secondary outcome [6]
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Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI)
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Assessment method [6]
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The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Moderate and severe flare: • Moderate: meeting criteria like SELENA-SLEDAI score change of 3 to 12 points, SLE symptom development, prednisone dose increase, non-steroidal anti-inflammatory drugs (NSAIDs)/hydrochloroquine addition, or PGA score increase by 1 to 2.5. • Severe: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. Annualized flare rate was calculated as the number of flares divided by flare exposure time in days, multiplied by 365.25 for each Group.
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Timepoint [6]
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Up to Week 52
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Secondary outcome [7]
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Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI
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Assessment method [7]
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The SFI, serves as a composite outcome measure incorporating the SELENA-SLEDAI score, and classifications of flares into mild, moderate, and severe, along with the PGA of disease activity. The SFI details specific clinical manifestations for each organ system and categorizes flares into mild, moderate, and severe based on treatment decisions. Severe flare: meeting criteria like SELENA-SLEDAI increase over 12 points, onset or worsening of severe symptoms, significant prednisone dose escalation, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group.
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Timepoint [7]
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Up to Week 52
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Secondary outcome [8]
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Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of "Worse" or "New" Resulting in a B-Score In = 2 Organs or an A-Score in = 1 Organ
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Assessment method [8]
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The BILAG flare index was derived from BILAG 2004, as measured by BILAG score designation of 'worse' or 'new' resulting in a B score in \>= 2 organs or an A score in \>= 1 organ. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days, multiplied by 365.25 for each Group.
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Timepoint [8]
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Up to Week 52
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Secondary outcome [9]
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Number of Participants With =6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving =50% Improvement From Baseline at Weeks 12, 24, 36, and 52
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Assessment method [9]
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The tender and swollen joint count is a physical assessment where for each swollen and tender joint a score of 1 is assigned. Scores are then summed up to provide a total score for both swollen and tender joints. Higher total score indicate a severe disease activity and a lower score indicates a lees severe disease activity.
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Timepoint [9]
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Week 12, 24, 36, and 52
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Secondary outcome [10]
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Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score =8 at Baseline Achieving =50% Improvement From Baseline at Weeks 12, 24, 36, and 52
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Assessment method [10]
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The CLASI is an assessment tool consisting of two scores: one for disease activity and one for damage. Activity Score: Ranges from 0 to 70, and is assessed based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia. Higher scores indicate more severe disease activity. Damage Score: Ranges from 0 to 56, and is evaluated through dyspigmentation and scarring, including scarring alopecia. Dyspigmentation that remains visible for more than 12 months is considered permanent, and its score is doubled. Higher scores indicate greater damage.
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Timepoint [10]
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Week 12, 24, 36, and 52
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Secondary outcome [11]
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Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52
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Assessment method [11]
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The PROMIS-Fatigue SF7a is a 7-item instrument that assesses the experience of fatigue as well as its impact on physical, mental and social activities. Each item is scored on a 5-point Likert scale, ranging from "1" (Never) to "5" (Always). The scores of all 7 items are summed up with a total raw score range of 7(low level of fatigue)-35(high level of fatigue). Raw scores are converted to a T-score ranging from 29.4(low level of fatigue)-83.2(high level of fatigue).
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Timepoint [11]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [12]
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Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [12]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [12]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [13]
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Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [13]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [13]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [14]
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Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [14]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [14]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [15]
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Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [15]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [15]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [16]
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Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [16]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [16]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [17]
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Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [17]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [17]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [18]
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Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [18]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [18]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [19]
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Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [19]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [19]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [20]
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Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [20]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [20]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [21]
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Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52
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Assessment method [21]
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The SF-36v2 (acute version) Health Survey consists of 36 items and serves as a patient-reported measure of health status. It assesses 8 domains of health-related quality of life: physical limitations, social limitations, role limitations due to physical health, bodily pain, mental health, role limitations due to emotional health, vitality, and general health perceptions. Each domain of the SF-36v2 produces a score ranging from 0 to 100, with higher scores indicating better health-related quality of life.
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Timepoint [21]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [22]
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Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52
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Assessment method [22]
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The LupusQoL questionnaire consists of 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Each item in the questionnaire is scored on a 5 point scale and items within a given domain are summed and converted to a 0-100 scale. Each domain is scored 0-100 with higher scores representing better quality of life in the specific domain. Lower scores signify poorer quality of life within the domain.
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Timepoint [22]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [23]
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Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52
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Assessment method [23]
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The PtGA assesses disease activity on a 10 cm numeric rating scale (NRS; 0 to 10 cm). The scale for the assessment ranges from "very well" (0) to "very poor" (10).
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Timepoint [23]
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Week 12, 24, 36, 44, and 52
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Secondary outcome [24]
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Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
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Assessment method [24]
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An adverse event (AE) was any negative medical occurrence linked to an intervention in humans, regardless of its relation to the intervention. Treatment-emergent AEs (TEAEs) were those that occurred after the first intervention dose. A serious adverse event (SAE) included outcomes such as death, life-threatening situations, hospitalization or an extended hospital stay, significant incapacity, congenital defects, or other crucial medical events. AE severity followed the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death). Clinically significant laboratory results or other assessments (e.g., ECGs, scans, vital signs) that worsened from baseline and were deemed important by the investigator, independent of disease progression, were also considered.
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Timepoint [24]
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Up to approximately 68 weeks
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Secondary outcome [25]
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Serum Concentration of Rozibafusp Alfa
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Assessment method [25]
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Timepoint [25]
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Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 44, Week 52, Week 56, Week 60, Week 64, and Week 68
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Secondary outcome [26]
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Terminal Half-life of Rozibafusp Alfa
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Assessment method [26]
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Timepoint [26]
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Up to Week 68
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Eligibility
Key inclusion criteria
Inclusion Criteria Screening Visit:
* Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
* Age = 18 years to = 75 years at screening visit.
* Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody = 1:80 by immunofluorescence on Hep-2 cells being present at screening.
* Hybrid SLEDAI score = 6 points with a "Clinical" hSLEDAI score = 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.
* Additional protocol-specific rules are applied at screening and throughout the study, as follows:
* Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring.
* Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia = 2.
* Oral ulcers: Ulcers location and appearance must be documented by the investigator.
* Scleritis and Episcleritis: the presence of stable SLE-related scleritis and episcleritis must be documented by an ophthalmologist and other causes excluded.
* Renal: subjects with urine protein/creatinine ratio < 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI = 4 and did not receive induction treatment for nephritis within the last year.
* Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI.
* Unless there is a documented intolerance, subjects must be taking:
* Only 1 of the following SLE treatments: anti-malarial (hydroxychloroquine, chloroquine, or quinacrine), azathioprine, methotrexate, leflunomide, mycophenolate mofetil/acid mycophenolic, or dapsone.
OR
• 2 of the above-mentioned SLE treatments in which 1 must be anti-malarial (hydroxychloroquine, chloroquine, or quinacrine).
* Treatment should be taken for = 12 weeks prior to screening and must be a stable dose for = 8 weeks prior to screening.
* For subjects taking OCS, dose must be = 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit for = 2 weeks prior to screening visit.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria Screening Visit
Subjects are excluded from the study if any of the following criteria apply:
Disease Related
* Urine protein creatinine ratio = 3000 mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit.
* Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/07/2023
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Sample size
Target
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Accrual to date
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Final
244
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [2]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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5011 - Woodville South
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Connecticut
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Georgia
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Illinois
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Louisiana
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Maryland
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Country [11]
0
0
United States of America
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State/province [11]
0
0
New York
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Country [12]
0
0
United States of America
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State/province [12]
0
0
North Carolina
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Oklahoma
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Pennsylvania
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Country [15]
0
0
United States of America
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State/province [15]
0
0
South Carolina
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Funding & Sponsors
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Commercial sector/industry
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Name
Amgen
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.
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Trial website
https://clinicaltrials.gov/study/NCT04058028
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Trial related presentations / publications
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.
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Public notes
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Contacts
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MD
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Amgen
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Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/28/NCT04058028/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/28/NCT04058028/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04058028
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