Trial Outcomes & Findings for Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis (NCT NCT05168475)

Last Updated: 2025-06-17

Results Overview

Primary treatment failure is progressive disease (defined by appearance of ≥1 new/worse severe or ≥3 new/worse non-severe items) on Birmingham vasculitis activity score (BVAS) v3 modified for BIOVAS trial (BVASv3-BIOVAS) or paediatric vasculitis activity score (PVAS) within 120 days from the time of IMP commencement; or failure to achieve clinical response (see definitions below) by 120 days from the time of IMP commencement. In such cases, TTF will be recorded as zero. We report this as number of events that occurred. As arms reached the number of events to define a median, we are reporting it as number of events.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

up to 720 days

Results posted on

2025-06-17

Participant Flow

4 participants were excluded as they did not meet the inclusion criteria

Participant milestones

Participant milestones
Measure	All Participants Including all randomisation assignments: Infliximab, Rituximab, Tocilizumab and Placebo
Period 1 STARTED	20
Period 1 Infliximab	7
Period 1 Rituximab	7
Period 1 Tocilizumab	3
Period 1 Placebo	1
Period 1 Not Randomised	2
Period 1 COMPLETED	15
Period 1 NOT COMPLETED	5
Period 2 STARTED	10
Period 2 Infliximab	4
Period 2 Rituximab	2
Period 2 Tocilizumab	4
Period 2 Placebo	0
Period 2 COMPLETED	9
Period 2 NOT COMPLETED	1
Period 3 STARTED	1
Period 3 Infliximab	1
Period 3 Rituximab	0
Period 3 Tocilizumab	0
Period 3 Placebo	0
Period 3 COMPLETED	0
Period 3 NOT COMPLETED	1
Period 4 STARTED	0
Period 4 COMPLETED	0
Period 4 NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Including all randomisation assignments: Infliximab, Rituximab, Tocilizumab and Placebo
Period 1 Protocol Violation	1
Period 1 IMP shortage	2
Period 1 Not randomised	2
Period 2 IMP shortage	1

Baseline Characteristics

Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=7 Participants Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose). Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.	Infliximab n=7 Participants Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Tocilizumab: Hospital-supplied stock.	Tocilizumab n=3 Participants Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed	Placebo n=1 Participants Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	12 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Age, Continuous	46.57 years STANDARD_DEVIATION 25.55 • n=5 Participants	48.57 years STANDARD_DEVIATION 14.41 • n=7 Participants	54.67 years STANDARD_DEVIATION 21.2 • n=5 Participants	58 years STANDARD_DEVIATION 0 • n=4 Participants	49.33 years STANDARD_DEVIATION 19.22 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	18 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United Kingdom	7 participants n=5 Participants	7 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	18 participants n=21 Participants
Disease group Giant Cell Arteritis	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Disease group Takayasu's Arteritis	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Disease group Polyarteritis Nodosa	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Disease group Relapsing Polychondritis	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Disease group IgA vasculitis	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Disease group Cogan's syndrome	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: up to 720 days

Outcome measures

Outcome measures
Measure	Infliximab n=12 Participants Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter.	Rituximab n=9 Participants Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose).	Tocilizumab n=7 Participants Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg.	Placebo n=1 Participants Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.
Treatment Failure	5 treatment failures	3 treatment failures	1 treatment failures	0 treatment failures

SECONDARY outcome

Timeframe: 120 days

Proportion of participants achieving response at the 120 day evaluation time point after the start of each IMP. The response status is defined by a BVAS v3-BIOVAS/ PVAS of ≤ one non-severe (no new/worse) item, prednisolone dose ≤ 50% of the dose at the start of the IMP treatment and ≤ 10mg/day (0.2 mg/kg/day for children, whichever is lower) and an ESR \< 30mm/hr or CRP \<10 mg/L

Outcome measures

Outcome measures
Measure	Infliximab n=12 Participants Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter.	Rituximab n=9 Participants Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose).	Tocilizumab n=7 Participants Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg.	Placebo n=1 Participants Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.
Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP	1 Participants	5 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 720 days

Proportion of participants achieving response at every 120 day evaluation time point defined by a BVAS v3-BIOVAS/ PVAS of ≤ 1 non-severe (no new/worse) item, prednisolone dose ≤ 50% of the dose at the start of the IMP treatment and ≤ 10mg/day (0.2 mg/kg/day for children, whichever is lower) and an ESR \< 30mm/hr or CRP \<10 mg/L

Outcome measures

Outcome measures
Measure	Infliximab n=12 Participants Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter.	Rituximab n=9 Participants Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose).	Tocilizumab n=7 Participants Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg.	Placebo n=1 Participants Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.
Patients Achieving Response at Any 120 Day Timepoint Day 240	6 Number of responders	4 Number of responders	2 Number of responders	1 Number of responders
Patients Achieving Response at Any 120 Day Timepoint Day 360	3 Number of responders	4 Number of responders	2 Number of responders	1 Number of responders
Patients Achieving Response at Any 120 Day Timepoint Day 480	2 Number of responders	1 Number of responders	1 Number of responders	1 Number of responders
Patients Achieving Response at Any 120 Day Timepoint Day 600	1 Number of responders	1 Number of responders	1 Number of responders	1 Number of responders
Patients Achieving Response at Any 120 Day Timepoint Day 720	0 Number of responders	1 Number of responders	0 Number of responders	1 Number of responders

SECONDARY outcome

Timeframe: VDI/PVDI scores were collected every 120 days at each scheduled visit in the trial until the last assessment at day 720 at the end of trial. 120 days, 240 days, 360 days, 480 days, 600 days and 720 days

Population: Number analysed differs in each row depending on time in study for each participant.

VDI/PVDI scores are collected from 11 different disease categories with each positive item scoring one mark. VDI/PVDI scores can either increase or stay the same at each measurement. All damage scores are carried forward to the next assessment. The minimum score is zero and the maximum score is 63. A low score indicates less damage and therefore a better outcome. A higher score indicates more damage and a worse outcome. Due to the study design, participants were kept on each intervention until treatment failure and then moved to the next in their allocated sequence. Secondary outcome data were collected from the start of the first treatment without restarting collection at each crossover. Therefore, results are presented by treatment sequence. The number of participants analysed includes all participants who received the given intervention at any time during the study.

Outcome measures

Outcome measures
Measure	Infliximab n=12 Participants Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter.	Rituximab n=9 Participants Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose).	Tocilizumab n=7 Participants Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg.	Placebo n=1 Participants Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.
Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment Day 600	0 score on a scale Interval 0.0 to 0.0	3 score on a scale Interval 2.5 to 3.5	3 score on a scale Interval 3.0 to 3.0	3 score on a scale Interval 3.0 to 3.0
Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment Baseline	1 score on a scale Interval 0.25 to 1.75	2 score on a scale Interval 1.0 to 3.0	1 score on a scale Interval 0.5 to 2.0	3 score on a scale Interval 3.0 to 3.0
Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment Day 120	1 score on a scale Interval 0.25 to 3.25	2 score on a scale Interval 2.0 to 2.0	2 score on a scale Interval 1.0 to 2.5	3 score on a scale Interval 3.0 to 3.0
Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment Day 240	1 score on a scale Interval 1.0 to 3.25	2 score on a scale Interval 1.25 to 2.75	1.5 score on a scale Interval 0.75 to 2.25	3 score on a scale Interval 3.0 to 3.0
Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment Day 360	1.5 score on a scale Interval 0.75 to 2.5	3 score on a scale Interval 2.0 to 3.0	1.5 score on a scale Interval 0.75 to 2.25	3 score on a scale Interval 3.0 to 3.0
Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment Day 480	2 score on a scale Interval 1.0 to 3.0	4 score on a scale Interval 3.5 to 4.5	3 score on a scale Interval 3.0 to 3.0	3 score on a scale Interval 3.0 to 3.0
Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment Day 720	0 score on a scale Interval 0.0 to 0.0	4 score on a scale Interval 4.0 to 4.0	—	3 score on a scale Interval 3.0 to 3.0

SECONDARY outcome

Timeframe: 120 days, 240 days, 360 days, 480 days, 600 days, 720 days

Population: Number analysed differs in each row depending on time in study for each participant

Physician's global assessment at every 120 day evaluation time point from the time of IMP commencement The Physician's global assessment (PGA) is a visual analogue scale from 0-10, where 0 is no disease activity (better outcome) and 10 is maximum disease activity (worse outcome). PGA scores are collected every 120 days at each scheduled visit for each participant (unless a visit is unscheduled which could occur at any time in between the time points). Due to the study design, participants were kept on each intervention until treatment failure and then moved to the next in their allocated sequence. Secondary outcome data were collected from the start of the first treatment without restarting collection at each crossover. Therefore, results are presented by treatment sequence. The number of participants analysed includes all participants who received the given intervention at any time during the study.

Outcome measures

Outcome measures
Measure	Infliximab n=12 Participants Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter.	Rituximab n=9 Participants Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose).	Tocilizumab n=7 Participants Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg.	Placebo n=1 Participants Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.
Physician's Global Assessment (PGA) (Likert Scale 0-10) Baseline	2.5 score on a scale Interval 2.0 to 3.0	4 score on a scale Interval 2.5 to 4.0	4 score on a scale Interval 3.5 to 4.5	5 score on a scale Interval 5.0 to 5.0
Physician's Global Assessment (PGA) (Likert Scale 0-10) Day 120	3.5 score on a scale Interval 2.25 to 4.75	1.5 score on a scale Interval 1.0 to 2.0	1 score on a scale Interval 1.0 to 1.5	2 score on a scale Interval 2.0 to 2.0
Physician's Global Assessment (PGA) (Likert Scale 0-10) Day 240	1 score on a scale Interval 1.0 to 1.75	1 score on a scale Interval 1.0 to 1.0	1 score on a scale Interval 1.0 to 1.0	2 score on a scale Interval 2.0 to 2.0
Physician's Global Assessment (PGA) (Likert Scale 0-10) Day 360	1.5 score on a scale Interval 1.0 to 2.25	2 score on a scale Interval 2.0 to 3.0	1 score on a scale Interval 1.0 to 1.0	1 score on a scale Interval 1.0 to 1.0
Physician's Global Assessment (PGA) (Likert Scale 0-10) Day 480	2.5 score on a scale Interval 2.25 to 2.75	1 score on a scale Interval 1.0 to 2.5	1 score on a scale Interval 1.0 to 1.0	1 score on a scale Interval 1.0 to 1.0
Physician's Global Assessment (PGA) (Likert Scale 0-10) Day 600	1 score on a scale Interval 1.0 to 1.0	1 score on a scale Interval 1.0 to 1.0	1 score on a scale Interval 1.0 to 1.0	1 score on a scale Interval 1.0 to 1.0
Physician's Global Assessment (PGA) (Likert Scale 0-10) Day 720	0 score on a scale Interval 0.0 to 0.0	1 score on a scale Interval 1.0 to 1.0	—	1 score on a scale Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: up to 720 days

Serious adverse events (SAEs) and adverse events of special interest (AESI) (where infection is considered an AESI)

Outcome measures

Outcome measures
Measure	Infliximab n=12 Participants Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter.	Rituximab n=1 Participants Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose).	Tocilizumab n=9 Participants Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg.	Placebo n=7 Participants Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.
Serious Adverse Events/Adverse Events of Special Interests (SAEs/AESIs) SAE	0 Number of Events	0 Number of Events	7 Number of Events	0 Number of Events
Serious Adverse Events/Adverse Events of Special Interests (SAEs/AESIs) AESI	21 Number of Events	2 Number of Events	17 Number of Events	0 Number of Events

Adverse Events

Infliximab

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Rituximab

Serious events: 3 serious events

Other events: 5 other events

Deaths: 1 deaths

Tocilizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab n=12 participants at risk Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Tocilizumab: Hospital-supplied stock.	Rituximab n=9 participants at risk Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose). Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.	Tocilizumab n=7 participants at risk Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed	Placebo n=1 participants at risk Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions. Rituximab: Hospital stock of rituximab used as intervention; biosimilars are allowed Infliximab: Hospital stock of infliximab is used in the trial; biosimilars are allowed Tocilizumab: Hospital-supplied stock.
Skin and subcutaneous tissue disorders vasculitis rash	0.00% 0/12 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	11.1% 1/9 • Number of events 1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/7 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.
Infections and infestations Septic shock	0.00% 0/12 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	11.1% 1/9 • Number of events 1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/7 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.
Infections and infestations Tonsillitis	0.00% 0/12 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	11.1% 1/9 • Number of events 1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/7 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.
Musculoskeletal and connective tissue disorders Polychondritis	0.00% 0/12 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	11.1% 1/9 • Number of events 1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/7 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.
Infections and infestations Oral candidiasis	0.00% 0/12 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	11.1% 1/9 • Number of events 1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/7 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.
Infections and infestations Cellulitis	0.00% 0/12 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	11.1% 1/9 • Number of events 1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/7 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.
Cardiac disorders Myocardial infarction	0.00% 0/12 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	11.1% 1/9 • Number of events 1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/7 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.
Respiratory, thoracic and mediastinal disorders respiratory failure	0.00% 0/12 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/9 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/7 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.	0.00% 0/1 • 24 months Only adverse events of special interest (AESIs) as described in section 12.3 will be reported from the point of informed consent until the end of participation in the trial for each participant. In addition to all SAEs, all infections requiring antimicrobial, antiviral or antifungal treatment are being collected as adverse events of special interest (AESIs) as part of the BIOVAS trial.

Other adverse events

Additional Information

Professor David Jayne

Cambridge University Hospitals NHS Foundation Trust

Phone: 01223 336816

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication or other dissemination of the Results (or any part of them) by any of the Parties shall not occur until the Lead has published the Results of the Project in the primary publication (the "Primary Publication").
Publication restrictions are in place

Restriction type: OTHER