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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02994927
Registration number
NCT02994927
Ethics application status
Date submitted
11/12/2016
Date registered
16/12/2016
Titles & IDs
Public title
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
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Scientific title
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine
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Secondary ID [1]
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ADVOCATE
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Secondary ID [2]
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CL010_168
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Universal Trial Number (UTN)
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Trial acronym
ADVOCATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
ANCA-Associated Vasculitis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Inflammatory and Immune System
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0
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Autoimmune diseases
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Human Genetics and Inherited Disorders
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0
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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 - Avacopan
Treatment: Drugs - Prednisone
Treatment: Drugs - Cyclophosphamide
Treatment: Other - Rituximab
Treatment: Drugs - Azathioprine
Active comparator: Prednisone group - Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
Experimental: Avacopan group - Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.
Treatment: Drugs: Avacopan
Avacopan 30 mg twice daily orally for 52 weeks (364 days):
- Three 10 mg avacopan capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.
Oral prednisone-matching placebo tapering regimen over 20 weeks (140 days):
* Prednisone-matching placebo capsules equivalent to 60 mg per day if the subject's body weight was =55 kg, or 45 mg per day if the subject's body weight was \<55 kg, starting on Day 1 with tapering according to a protocol-specified schedule.
* Adolescents who weighed =37 kg started at a prednisone-matching placebo dose of 30 mg per day.
Treatment: Drugs: Prednisone
Avacopan-matching placebo twice daily orally for 52 weeks (364 days):
- Three avacopan-matching placebo capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose.
Oral prednisone tapering regimen over 20 weeks (140 days):
* Prednisone 60 mg per day if the subject's body weight was =55 kg, or 45 mg per day if the subject's body weight was \<55 kg, starting on Day 1 with tapering according to the protocol-specified schedule.
* Adolescents who weighed =37 kg started at a prednisone dose of 30 mg per day.
Treatment: Drugs: Cyclophosphamide
Orally or intravenously administered
Treatment: Other: Rituximab
Intravenously administered
Treatment: Drugs: Azathioprine
Orally administered
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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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 Subjects Achieving Disease Remission at Week 26
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Assessment method [1]
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Disease remission at Week 26 was defined as:
* Achieving a BVAS of 0 as determined by the Adjudication Committee;
* No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;
* No BVAS \>0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment).
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Timepoint [1]
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Week 26
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Primary outcome [2]
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Percentage of Subjects Achieving Sustained Disease Remission at Week 52
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Assessment method [2]
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Sustained remission at Week 52 was defined as:
* Disease remission at Week 26 as defined above;
* Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;
* No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee.
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Timepoint [2]
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Week 52
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Secondary outcome [1]
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Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs
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Assessment method [1]
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AEs=Adverse events
SAEs=Serious adverse events
TEAE=Treatment-emergent adverse event
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Timepoint [1]
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From day 1 throughout the study period (day 421/week 60)
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Secondary outcome [2]
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Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI
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Assessment method [2]
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GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;
GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;
The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health).
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Timepoint [2]
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Baseline, Week 13 and 26
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Secondary outcome [3]
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Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC
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Assessment method [3]
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AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
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Timepoint [3]
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Week 4
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Secondary outcome [4]
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Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index
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Assessment method [4]
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SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)
EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels
The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health).
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Timepoint [4]
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Baseline, Week 26 and 52
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Secondary outcome [5]
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Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study
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Assessment method [5]
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The median time to relapse was not estimable because of small number of relapsed subjects.
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or
2. having achieved BVAS=0 at any time during the treatment period
ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
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Timepoint [5]
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Week 52
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Secondary outcome [6]
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Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period
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Assessment method [6]
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The median time to relapse was not estimable because of small number of relapsed subjects.
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or
2. having achieved BVAS=0 at any time during the treatment period
The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
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Timepoint [6]
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Week 52
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Secondary outcome [7]
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In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks
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Assessment method [7]
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Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.
eGFR=estimated glomerular filtration rate
BVAS=Birmingham Vasculitis Activity Score
MDRD=Modification of Diet in Renal Disease
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Timepoint [7]
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Baseline, Week 26 and 52
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Secondary outcome [8]
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In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks
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Assessment method [8]
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BVAS=Birmingham Vasculitis Activity Score
UACR=Urinary albumin:creatinine ratio
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Timepoint [8]
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Baseline, Week 4, 26 and 52
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Secondary outcome [9]
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In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks
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Assessment method [9]
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BVAS=Birmingham Vasculitis Activity Score
MCP-1=monocyte chemoattractant protein-1
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Timepoint [9]
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Baseline, Week 26 and 52
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Secondary outcome [10]
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Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points
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Assessment method [10]
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VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health).
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Timepoint [10]
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Baseline, Week 26 and 52
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Secondary outcome [11]
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)
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Assessment method [11]
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0
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Timepoint [11]
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Baseline, Week 26 and 52
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Secondary outcome [12]
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)
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Assessment method [12]
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0
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Timepoint [12]
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0
Baseline, Week 26 and 52
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Secondary outcome [13]
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)
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Assessment method [13]
0
0
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Timepoint [13]
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0
Baseline, Week 26 and 52
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Secondary outcome [14]
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)
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Assessment method [14]
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0
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Timepoint [14]
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0
Baseline, Week 26 and 52
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Secondary outcome [15]
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)
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Assessment method [15]
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0
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Timepoint [15]
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Baseline, Week 26 and 52
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Secondary outcome [16]
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)
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Assessment method [16]
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0
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Timepoint [16]
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Baseline, Week 26 and 52
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Secondary outcome [17]
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Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)
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Assessment method [17]
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0
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Timepoint [17]
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Baseline, Week 26 and 52
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Secondary outcome [18]
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Change From Baseline in Vital Signs (1/5)
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Assessment method [18]
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0
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Timepoint [18]
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0
Baseline, Week 26 and 52
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Secondary outcome [19]
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0
Change From Baseline in Vital Signs (2/5)
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Assessment method [19]
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0
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Timepoint [19]
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0
Baseline, Week 26 and 52
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Secondary outcome [20]
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0
Change From Baseline in Vital Signs (3/5)
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Assessment method [20]
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0
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Timepoint [20]
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0
Baseline, Week 26 and 52
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Secondary outcome [21]
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0
Change From Baseline in Vital Signs (4/5)
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Assessment method [21]
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0
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Timepoint [21]
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0
Baseline, Week 26 and 52
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Secondary outcome [22]
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0
Change From Baseline in Vital Signs (5/5)
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Assessment method [22]
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BMI=Body Mass Index
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Timepoint [22]
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Baseline, Week 26 and 52
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Secondary outcome [23]
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Number of Subjects With Clinically Significant ECG Changes From Baseline
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Assessment method [23]
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Clinical significance was assessed by the individual reading of the ECGs
ECG=Electrocardiogram
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Timepoint [23]
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From day 1 throughout the study period (day 421/week 60)
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Secondary outcome [24]
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Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator
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Assessment method [24]
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AE=Adverse Event
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Timepoint [24]
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From day 1 throughout the study period (day 421/week 60)
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Secondary outcome [25]
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Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity
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Assessment method [25]
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WBC=White Blood Cell
TEAE=Treatment-Emergent Adverse Event
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Timepoint [25]
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From day 1 throughout the study period (day 421/week 60)
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Secondary outcome [26]
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Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study
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Assessment method [26]
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BVAS=Birmingham Vasculitis Activity Score;
A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:
1. having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or
2. having achieved BVAS=0 at any time during the treatment period
The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health).
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Timepoint [26]
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0
From day 1 throughout the study period (day 421/week 60)
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Eligibility
Key inclusion criteria
* Clinical diagnosis of granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis
* Male and female subjects, aged at least 18 years, with newly-diagnosed or relapsed associated vasculitis (AAV) where treatment with cyclophosphamide or rituximab is needed; where approved by Regulatory Agencies, adolescents (12-17 year old) may be enrolled
* Use of adequate contraception
* Positive test for anti-proteinase 3 (PR3) or anti-myeloperoxidase (MPO)
* At least 1 major item, or at least 3 non-major items, or at least the 2 renal items of proteinuria and hematuria on Birmingham Vasculitis Activity Score (BVAS)
* Estimated glomerular filtration rate =15 mL/minute/1.73 m^2 at screening
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Minimum age
12
Years
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Maximum age
No limit
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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
* Pregnant or breast-feeding
* Alveolar hemorrhage requiring pulmonary ventilation support at screening
* Any other known multi-system autoimmune disease
* Required dialysis or plasma exchange within 12 weeks prior to screening
* Have a kidney transplant
* Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1
* Received intravenous glucocorticoids, >3000 mg methylprednisolone equivalent, within 4 weeks prior to screening
* Have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening
* Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred (i.e., CD19 count > 0.01x10^9/L); received anti-tumor necrosis factor (TNF) treatment, abatacept, alemtuzumab, intravenous immunoglobulin (IVIg), belimumab, tocilizumab, or eculizumab within 12 weeks prior to screening
* For patients scheduled to receive cyclophosphamide treatment, urinary outflow obstruction, active infection (especially varicella zoster infection), or platelet count <50,000/µL before start of dosing
* Participated previously in a CCX168 study
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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 3
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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
15/03/2017
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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
1/11/2019
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Sample size
Target
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Accrual to date
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Final
331
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Clinical Trial Site - Adelaide
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Recruitment hospital [2]
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Clinical Trial Site - Auchenflower
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Recruitment hospital [3]
0
0
Clinical Trial Site - Brisbane
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Recruitment hospital [4]
0
0
Clinical Trial Site - Clayton
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Recruitment hospital [5]
0
0
Clinical Trial Site - Concord
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Recruitment hospital [6]
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0
Clinical Trial Site - Heidelberg
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Recruitment hospital [7]
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Clinical Trial Site - Liverpool
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Recruitment hospital [8]
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0
Clinical Trial Site - Nambour
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Recruitment hospital [9]
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0
Clinical Trial Site - Nedlands
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Recruitment hospital [10]
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0
Clinical Trial Site - Randwick
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Recruitment hospital [11]
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0
Clinical Trial Site - Saint Albans
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Recruitment hospital [12]
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0
Clinical Trial Site - Southport
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Recruitment hospital [13]
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0
Clinical Trial Site - St Leonards
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Recruitment hospital [14]
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0
Clinical Trial Site - Westmead
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Recruitment hospital [15]
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0
Clinical Trial Site - Woolloongabba
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Recruitment postcode(s) [1]
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0
- Adelaide
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Recruitment postcode(s) [2]
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0
- Auchenflower
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Recruitment postcode(s) [3]
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0
- Brisbane
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Recruitment postcode(s) [4]
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0
- Clayton
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Recruitment postcode(s) [5]
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0
- Concord
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Recruitment postcode(s) [6]
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0
- Heidelberg
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Recruitment postcode(s) [7]
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0
- Liverpool
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Recruitment postcode(s) [8]
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0
- Nambour
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Recruitment postcode(s) [9]
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0
- Nedlands
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Recruitment postcode(s) [10]
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0
- Randwick
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Recruitment postcode(s) [11]
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0
- Saint Albans
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Recruitment postcode(s) [12]
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0
- Southport
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Recruitment postcode(s) [13]
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0
- St Leonards
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Recruitment postcode(s) [14]
0
0
- Westmead
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Recruitment postcode(s) [15]
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0
- Woolloongabba
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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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Alabama
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0
United States of America
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State/province [2]
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Arizona
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0
United States of America
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0
California
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0
United States of America
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State/province [4]
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0
Colorado
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0
0
United States of America
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State/province [5]
0
0
District of Columbia
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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]
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0
Idaho
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Illinois
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Indiana
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Country [11]
0
0
United States of America
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State/province [11]
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0
Kansas
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Country [12]
0
0
United States of America
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State/province [12]
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0
Kentucky
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0
0
United States of America
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State/province [13]
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0
Louisiana
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Country [14]
0
0
United States of America
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State/province [14]
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0
Maryland
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Country [15]
0
0
United States of America
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State/province [15]
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0
Massachusetts
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Country [16]
0
0
United States of America
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State/province [16]
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0
Michigan
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0
0
United States of America
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State/province [17]
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0
Minnesota
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0
United States of America
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State/province [18]
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0
Missouri
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0
0
United States of America
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State/province [19]
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New York
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Country [20]
0
0
United States of America
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North Carolina
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United States of America
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State/province [21]
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Ohio
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0
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State/province [22]
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Pennsylvania
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0
0
United States of America
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State/province [23]
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0
Rhode Island
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0
0
United States of America
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State/province [24]
0
0
South Carolina
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0
0
United States of America
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State/province [25]
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0
Texas
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Country [26]
0
0
United States of America
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State/province [26]
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0
Utah
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Country [27]
0
0
United States of America
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State/province [27]
0
0
Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ChemoCentryx
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Address
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Ethics approval
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Summary
Brief summary
The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.
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Trial website
https://clinicaltrials.gov/study/NCT02994927
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Trial related presentations / publications
Harigai M, Kaname S, Tamura N, Dobashi H, Kubono S, Yoshida T. Efficacy and safety of avacopan in Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis: A subanalysis of a randomized Phase 3 study. Mod Rheumatol. 2023 Mar 2;33(2):338-345. doi: 10.1093/mr/roac037. Erratum In: Mod Rheumatol. 2024 May 27:roae045. doi: 10.1093/mr/roae045. Soulsby WD. Journal Club Review of "Avacopan for the Treatment of ANCA-Associated Vasculitis". ACR Open Rheumatol. 2022 Jul;4(7):558-561. doi: 10.1002/acr2.11412. Epub 2022 Feb 15. Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021 Feb 18;384(7):599-609. doi: 10.1056/NEJMoa2023386. Erratum In: N Engl J Med. 2024 Jan 25;390(4):388. doi: 10.1056/NEJMx230010. Merkel PA, Jayne DR, Wang C, Hillson J, Bekker P. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial. JMIR Res Protoc. 2020 Apr 7;9(4):e16664. doi: 10.2196/16664.
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
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Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/27/NCT02994927/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/27/NCT02994927/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/NCT02994927