Trial · NCT05168475

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

NCT05168475, Phase 2, Terminated, Cambridge University Hospitals NHS Foundation Trust; results first posted 2025-06-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis. Trials, record NCT05168475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05168475

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis
NCT number: NCT05168475
Status: Terminated
Phases: Phase 2
Enrollment: 22 participants, actual
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Conditions: Giant Cell Arteritis, Takayasu Arteritis, Cogan Syndrome, Relapsing Polychondritis, Cryoglobulinemic Vasculitis, IgA Vasculitis, Polyarteritis Nodosa, Cutaneous Polyarteritis Nodosa, Primary Angiitis of Central Nervous System
Interventions: Rituximab, Infliximab, Tocilizumab
First posted: 2021-12-23
Last updated: 2025-06-17
Results first posted: 2025-06-17
Limitations and caveats: The recruitment period was planned to be 29 months, however study activities were halted after 20 months due to funding being withdrawn.~18 participants were randomised rather than the intended sample size of 140. Due to the small number of participants recruited the analyses are mainly descriptive.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Failure	up to 720 days	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.
Secondary	Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP	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
Secondary	Patients Achieving Response at Any 120 Day Timepoint	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
Secondary	Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment	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	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.
Secondary	Physician's Global Assessment (PGA) (Likert Scale 0-10)	120 days, 240 days, 360 days, 480 days, 600 days, 720 days	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.
Secondary	Serious Adverse Events/Adverse Events of Special Interests (SAEs/AESIs)	up to 720 days	Serious adverse events (SAEs) and adverse events of special interest (AESI) (where infection is considered an AESI)

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Failure	up to 720 days		treatment failures	NUMBER
SECONDARY	Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP	120 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Patients Achieving Response at Any 120 Day Timepoint	up to 720 days		Number of responders	NUMBER
SECONDARY	Increase in Disease Related Damage Measured by Vasculitis Damage Index/Paediatric Vasculitis Damage Index (VDI/PVDI) From Start to End of an IMP Treatment	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	Number analysed differs in each row depending on time in study for each participant.	score on a scale	MEDIAN
SECONDARY	Physician's Global Assessment (PGA) (Likert Scale 0-10)	120 days, 240 days, 360 days, 480 days, 600 days, 720 days	Number analysed differs in each row depending on time in study for each participant	score on a scale	MEDIAN
SECONDARY	Serious Adverse Events/Adverse Events of Special Interests (SAEs/AESIs)	up to 720 days		Number of Events	NUMBER

Source ClinicalTrials.gov

Results by group90

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Treatment Failure	Infliximab		5	treatment failures
Treatment Failure	Rituximab		3	treatment failures
Treatment Failure	Tocilizumab		1	treatment failures
Treatment Failure	Placebo		0	treatment failures
Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP	Infliximab		1	Participants
Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP	Rituximab		5	Participants
Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP	Tocilizumab		3	Participants
Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP	Placebo		1	Participants
Patients Achieving Response at Any 120 Day Timepoint	Infliximab	Day 240	6	Number of responders
Patients Achieving Response at Any 120 Day Timepoint	Rituximab	Day 240	4	Number of responders

1 to 10 of 90Source ClinicalTrials.gov

See all 90 results by group

Participant flow25

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	All Participants	20
Period 1	Infliximab	All Participants	7
Period 1	Rituximab	All Participants	7
Period 1	Tocilizumab	All Participants	3
Period 1	Placebo	All Participants	1
Period 1	Not Randomised	All Participants	2
Period 1	COMPLETED	All Participants	15
Period 1	NOT COMPLETED	All Participants	5
Period 2	STARTED	All Participants	10
Period 2	Infliximab	All Participants	4

1 to 10 of 25Source ClinicalTrials.gov

See all 25 participant flow

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cellulitis	Infections and infestations	Infliximab	1	12	1
other	Cellulitis	Infections and infestations	Rituximab	0	9	0
other	Cellulitis	Infections and infestations	Tocilizumab	0	7	0
other	Cellulitis	Infections and infestations	Placebo	0	1	0
other	Covid-19	Infections and infestations	Infliximab	1	12	1
other	Covid-19	Infections and infestations	Rituximab	0	9	0
other	Covid-19	Infections and infestations	Tocilizumab	0	7	0
other	Covid-19	Infections and infestations	Placebo	1	1	1
other	E.Coli Urinary Tract Infection	Infections and infestations	Infliximab	0	12	0
other	E.Coli Urinary Tract Infection	Infections and infestations	Rituximab	1	9	1

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Infliximab	0	12
Total, all-cause mortality	Rituximab	1	9
Total, all-cause mortality	Tocilizumab	0	7
Total, all-cause mortality	Placebo	0	1
Total, other adverse events	Infliximab	7	12
Total, other adverse events	Rituximab	5	9
Total, other adverse events	Tocilizumab	0	7
Total, other adverse events	Placebo	1	1
Total, serious adverse events	Infliximab	0	12
Total, serious adverse events	Rituximab	3	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05168475

GET https://conductscience.org/api/trials/v1/NCT05168475/results?page=2

API reference For AI assistants