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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03845517
Registration number
NCT03845517
Ethics application status
Date submitted
15/02/2019
Date registered
19/02/2019
Date last updated
5/09/2024
Titles & IDs
Public title
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
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Scientific title
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
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Secondary ID [1]
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2018-004175-12
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Secondary ID [2]
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B7931028
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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
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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 - Placebo
Treatment: Drugs - PF-06700841 15 mg
Treatment: Drugs - PF-06700841 30 mg
Treatment: Drugs - PF-06700841 45 mg
Placebo comparator: Placebo - Placebo
Experimental: PF-06700841 15 mg - PF-06700841 15 mg
Experimental: PF-06700841 30 mg - PF-06700841 30 mg
Experimental: PF-06700841 45 mg - PF-06700841 45 mg
Treatment: Drugs: Placebo
Placebo
Treatment: Drugs: PF-06700841 15 mg
PF-06700841 15 mg
Treatment: Drugs: PF-06700841 30 mg
PF-06700841 30 mg
Treatment: Drugs: PF-06700841 45 mg
PF-06700841 45 mg
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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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Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52
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Assessment method [1]
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SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (\>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than \[\<\] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52
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Assessment method [1]
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BICLA included: BILAG-2004, SLEDAI-2K and PhGA. Participants were classified as responders, if they met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =\<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (\<10 percent \[%\] worsening) in analogue PhGA. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
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Assessment method [2]
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LLDAS was defined as SLE disease activity index (SLEDAI-2k \<=4, with no activity in major organ systems \[renal, central nervous system, cardiopulmonary, vasculitis, fever\]) and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with the previous assessment; a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI PhGA (scale 0-3; higher scores = higher severity) \<=1; a current prednisolone (or equivalent) dose \<=7.5 milligram per day (mg/daily); and well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/Day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline
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Assessment method [3]
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In this outcome measure data is reported for participants who achieved a reduction in prednisone (or equivalent) dose to \<=7.5 mg/day and sustained for 12 Weeks prior at Week 52 and they also sustained this dose reduction for 12 weeks prior to Week 52 (Week 40 to Week 52).
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Timepoint [3]
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Week 52 for achieving reduction in dose along with Week 40 to Week 52 for sustained dosing
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Secondary outcome [4]
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Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/Day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline
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Assessment method [4]
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In this outcome measure data is reported for participants who achieved a reduction in SRI-4 response with prednisone dose reduced to \<=7.5 mg/day and sustained for 12 weeks at Week 52.
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Timepoint [4]
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12 Weeks prior at Week 52 (Week 40 to Week 52)
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Secondary outcome [5]
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Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10
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Assessment method [5]
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CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).
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Timepoint [5]
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Week 52
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Secondary outcome [6]
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Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
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Assessment method [6]
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The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
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Timepoint [6]
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Baseline, Week 52
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Secondary outcome [7]
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Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52
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Assessment method [7]
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The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others; measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Physical health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
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Timepoint [7]
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Baseline, Week 52
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Secondary outcome [8]
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Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52
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Assessment method [8]
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The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Emotional health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
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Timepoint [8]
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Baseline, Week 52
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Secondary outcome [9]
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Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52
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Assessment method [9]
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The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Body image domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
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Timepoint [9]
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Baseline, Week 52
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Secondary outcome [10]
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Change From Baseline in Pain Domain Scores of LupusQoL at Week 52
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Assessment method [10]
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The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Pain domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
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Timepoint [10]
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Baseline, Week 52
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Secondary outcome [11]
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Change From Baseline in Planning Domain Scores of LupusQoL at Week 52
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Assessment method [11]
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The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Planning domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
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Timepoint [11]
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Baseline, Week 52
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Secondary outcome [12]
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Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52
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Assessment method [12]
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The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Fatigue domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
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Timepoint [12]
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Baseline, Week 52
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Secondary outcome [13]
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Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52
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Assessment method [13]
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The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Intimate relationship domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
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Timepoint [13]
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Baseline, Week 52
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Secondary outcome [14]
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Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52
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Assessment method [14]
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The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Burden to others domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
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Timepoint [14]
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Baseline, Week 52
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Secondary outcome [15]
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Incidence Rate of Severe Flare Event
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Assessment method [15]
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Incidence rate was defined as the number of new events per 100 person-years.
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Timepoint [15]
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Week 52
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Secondary outcome [16]
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Number of Participants With Treatment-Emergent Adverse Events (AE)
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Assessment method [16]
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An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are events from first dose of study intervention to 4 weeks after last dose of study intervention that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs.
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Timepoint [16]
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Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
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Secondary outcome [17]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [17]
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An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Timepoint [17]
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Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
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Secondary outcome [18]
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Number of Participants With Adverse Events Leading to Discontinuation From Study
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Assessment method [18]
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An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. In this outcome measure, participants with adverse events leading to discontinuation from study were reported.
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Timepoint [18]
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Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
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Secondary outcome [19]
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Number of Participants With Clinically Significant Vital Signs Abnormalities
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Assessment method [19]
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Vital signs included blood pressure, pulse rate, respiratory rate, and temperature. Clinical significance in vital signs abnormalities was judged by investigator.
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Timepoint [19]
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Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
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Secondary outcome [20]
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
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Assessment method [20]
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Clinical significance in ECG abnormalities was judged by investigator.
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Timepoint [20]
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Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
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Secondary outcome [21]
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Number of Participants With Laboratory Test Abnormalities
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Assessment method [21]
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Hematology (Hemoglobin\[hgb\], hematocrit, erythrocytes\[ery\]:\<0.8\*lower limit of normal\[LLN\];reticulocytes, reticulocytes/ery:\<0.5\*LLN,\>1.5\*upper LN\[ULN\];ery mean corpuscular volume\[EMC\], EMC hgb:\<0.9\*LLN,\>1.5\*ULN;EMC hgb concentration:\<0.9\* LLN;platelet:\<0.5\*LLN;leukocytes\[leu\]:\<0.6\*LLN,\>1.5\*ULN;lymphocytes, lymphocytes/leu, neutrophils, neutrophils/leu:\<0.8\* LLN,\>1.2\*ULN;basophils, basophils/leu, eosinophils, eosinophils/leu, monocytes, monocytes/leu:\>1.2\*ULN;activated partial thromboplastin time\[PTT\], PTT, prothrombin time:\>1.1\*ULN);Clinical chemistry (Total/direct/indirect bilirubin, glucose-fasting:\>1.5\*ULN; aspartate aminotransferase\[AT\], alanine AT:\>3.0\*ULN; protein, albumin, HDL cholesterol:\<0.8\*LLN;urea nitrogen, creatinine, triglyceride, cholesterol:\>1.3\*ULN;urate, LDL cholesterol:\>1.2\*ULN;potassium:\<0.9\*LLN,\>1.1\*ULN;calcium, bicarbonate:\<0.9\*LLN;creatine kinase:\>2.0\*ULN);Urinalysis (pH\<4.5;glucose, protein, hgb, ketones, nitrite, leu esterase, granular/hyaline/WBCs casts:\>1).
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Timepoint [21]
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Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)
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Eligibility
Key inclusion criteria
* Male and/or female subjects between =18 and =75 years of age inclusive.
* Diagnosis of moderate to severe active Lupus.
* Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.
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Minimum age
18
Years
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Maximum age
75
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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
* Active renal lupus
* Severe active central nervous system (CNS) lupus
* Have cancer or a history of cancer within 5 years of screening.
* Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus.
* Active bacterial, viral, fungal, mycobacterial or other infections
* Psychiatric condition including recent or active suicidal ideation or behavior
* Have active fibromyalgia/myofascial/chronic pain.
* Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
18/04/2019
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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
5/10/2023
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Sample size
Target
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Accrual to date
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Final
350
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Optimus Clinical Research - Kogarah
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Recruitment hospital [2]
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Emeritus Research - Camberwell
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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3124 - Camberwell
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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0
0
United States of America
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California
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0
United States of America
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0
Connecticut
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0
United States of America
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0
Florida
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0
United States of America
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0
Georgia
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0
0
United States of America
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0
Idaho
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0
0
United States of America
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0
Kansas
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0
United States of America
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0
Louisiana
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0
United States of America
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0
Michigan
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0
0
United States of America
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State/province [10]
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0
Nevada
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0
0
United States of America
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0
New York
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0
0
United States of America
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State/province [12]
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0
North Carolina
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0
0
United States of America
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State/province [13]
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0
Oklahoma
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0
0
United States of America
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0
Tennessee
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0
United States of America
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Texas
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United States of America
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Washington
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Argentina
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Tucuman
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Belgium
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Leuven
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Belgium
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Merksem
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Bulgaria
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Plovdiv
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Bulgaria
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0
Ruse
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Bulgaria
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Sofia
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0
0
Canada
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Quebec
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0
0
China
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State/province [24]
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Anhui
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China
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State/province [25]
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0
Hunan
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0
0
China
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State/province [26]
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0
Jiangsu
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0
0
China
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State/province [27]
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0
Tianjin
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0
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China
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Beijing
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China
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Shanghai
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0
0
Colombia
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0
Antioquia
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0
0
Colombia
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Atlantico
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Colombia
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Cundinamarca
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Colombia
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State/province [33]
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0
Santander
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0
0
Czechia
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0
Praha 2
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0
France
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Paris
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France
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Pessac
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Germany
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Hannover
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0
Germany
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0
Lübeck
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Greece
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Crete
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Greece
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State/province [40]
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Athens
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Country [41]
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Daegu
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Sosnowiec
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Warszawa
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Portugal
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Almada
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Portugal
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Amadora
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Portugal
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Ponte de Lima
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Portugal
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Porto
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Romania
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JUD. Brasov
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Romania
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Jud. Cluj
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Romania
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Sector 1
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Romania
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Bucuresti
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Serbia
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Beograd
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Serbia
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Niska Banja
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Spain
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Pontevedra
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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La Coruna
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Spain
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Sevilla
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Taiwan (r.o.c)
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Ternopil
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsia
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United Kingdom
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Hampshire
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United Kingdom
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Doncaster
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United Kingdom
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Leeds
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
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Trial website
https://clinicaltrials.gov/study/NCT03845517
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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
Principal investigator
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0
Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
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/17/NCT03845517/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/17/NCT03845517/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/NCT03845517
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