A Phase 2 interventional study of Rituximab and Infliximab in Giant Cell Arteritis, Takayasu Arteritis and Cogan Syndrome, sponsored by Cambridge University Hospitals NHS Foundation Trust. Terminated at 5 sites in United Kingdom. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Phase 2, Interventional, and Treatment
Vasculitis occur when the body's immune system, rather than protecting the body, attacks blood vessels, causing injury to the vessel and the part of the body it supplies with blood. Vasculitis is rare, and there are a number of different types, which can affect both adults and children. We treat vasculitis with steroids and drugs aiming to damp down the activity of the immune system, but they often cause side effects. Some patients do not improve with this treatment, or cannot tolerate it and their vasculitis worsens; this is known as refractory vasculitis. Patients with refractory vasculitis are at high risk of health complications from the disease and its therapy and are in need of newer more effective treatments with fewer side effects.
Biologics are drugs which are designed to precisely target parts of the immune system and may have fewer side effects. Biologics have been used for several years to treat vasculitis, particularly anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis or AAV. However, for many of the rarer types of vasculitis, and especially those vasculitis disease types that are not ANCA-associated, there is little information to support use of biologic therapies as effective treatments.
The purpose of this trial is to find out whether biologics are effective and represent value for money for participants with refractory vasculitis. The trial will include patients with Non-ANCA-associated vasculitis (NAAV)
The trial is a multi-centre, randomised, double-blind, placebo-controlled, modified-crossover design which will investigate three biologics, Infliximab, Rituximab, Tocilizumab, and placebos to each, in the treatment of refractory non-ANCA-associated Vasculitis (NAAV) in adults and children. Eligible patients are randomised to a sequence of up to 4 interventions (comprising 3 biologics and 1 placebo to one of the three biologics being studied). Patients remain on first intervention in their randomised sequence for up to 2 years, or until they are deemed to fail treatment or experience a severe disease relapse, at which point they will be switched to the next intervention in their randomised sequence. When a patient switches to the next intervention in their randomised sequence, they will again remain on treatment either until the end of treatment period or until they fail treatment or experience a severe disease relapse. Patients remain on the treatment period for a maximum of 2 years, or until they have failed/experienced severe relapses on every treatment in their randomised sequence, whichever is sooner. Patients will be assessed for disease activity and relapse every 120 days up to D720.
147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's enrollment of 22 is below the median of 64 across 65 interventional studies indexed under Giant Cell Arteritis.
Browse Giant Cell Arteritis studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 171 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
disease defined by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose).
Biological: Infliximab · Biological: Tocilizumab
Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter.
Biological: Rituximab · Biological: Tocilizumab
Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg.
Biological: Rituximab · Biological: Infliximab
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.
Biological: Rituximab · Biological: Infliximab · Biological: Tocilizumab
Hospital stock of rituximab used as intervention; biosimilars are allowed
Hospital stock of infliximab is used in the trial; biosimilars are allowed
Hospital-supplied stock.
Treatment Failure
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.
Time frame: up to 720 days
Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP
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
Time frame: 120 days
Patients Achieving Response at Any 120 Day Timepoint
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
Time frame: up to 720 days
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 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.
Time frame: 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
Physician's Global Assessment (PGA) (Likert Scale 0-10)
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.
Time frame: 120 days, 240 days, 360 days, 480 days, 600 days, 720 days
Serious Adverse Events/Adverse Events of Special Interests (SAEs/AESIs)
Serious adverse events (SAEs) and adverse events of special interest (AESI) (where infection is considered an AESI)
Time frame: up to 720 days
| Milestone | All Participants |
|---|---|
| Started | 20 |
| Infliximab | 7 |
| Rituximab | 7 |
| Tocilizumab | 3 |
| Placebo | 1 |
| Not randomised | 2 |
| Completed | 15 |
| Not completed | 5 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Imp shortage | 2 |
| Withdrew: Not randomised | 2 |
| Milestone | All Participants |
|---|---|
| Started | 10 |
| Infliximab | 4 |
| Rituximab | 2 |
| Tocilizumab | 4 |
| Placebo | 0 |
| Completed | 9 |
| Not completed | 1 |
| Withdrew: Imp shortage | 1 |
| Milestone | All Participants |
|---|---|
| Started | 1 |
| Infliximab | 1 |
| Rituximab | 0 |
| Tocilizumab | 0 |
| Placebo | 0 |
| Completed | 0 |
| Not completed | 1 |
| Milestone | All Participants |
|---|---|
| Started | 0 |
| Completed | 0 |
| Not completed | 0 |
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.
| treatment failures | Infliximab | Rituximab | Tocilizumab | Placebo |
|---|---|---|---|---|
| Treatment Failure | 5 | 3 | 1 | 0 |
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
| Participants | Infliximab | Rituximab | Tocilizumab | Placebo |
|---|---|---|---|---|
| Patients Achieving Response at the 120 Day Timepoint Following Commencement of IMP | 1 | 5 | 3 | 1 |
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
| Number of responders | Infliximab | Rituximab | Tocilizumab | Placebo |
|---|---|---|---|---|
| Day 240 | 6 | 4 | 2 | 1 |
| Day 360 | 3 | 4 | 2 | 1 |
| Day 480 | 2 | 1 | 1 | 1 |
| Day 600 | 1 | 1 | 1 | 1 |
| Day 720 | 0 | 1 | 0 | 1 |
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.
| score on a scale | Infliximab | Rituximab | Tocilizumab | Placebo |
|---|---|---|---|---|
| Baseline | 1 (0.25 to 1.75) | 2 (1 to 3) | 1 (0.5 to 2) | 3 (3 to 3) |
| Day 120 | 1 (0.25 to 3.25) | 2 (2 to 2) | 2 (1 to 2.5) | 3 (3 to 3) |
| Day 240 | 1 (1 to 3.25) | 2 (1.25 to 2.75) | 1.5 (0.75 to 2.25) | 3 (3 to 3) |
| Day 360 | 1.5 (0.75 to 2.5) | 3 (2 to 3) | 1.5 (0.75 to 2.25) | 3 (3 to 3) |
| Day 480 | 2 (1 to 3) | 4 (3.5 to 4.5) | 3 (3 to 3) | 3 (3 to 3) |
| Day 600 | 0 (0 to 0) | 3 (2.5 to 3.5) | 3 (3 to 3) | 3 (3 to 3) |
| Day 720 | 0 (0 to 0) | 4 (4 to 4) | — | 3 (3 to 3) |
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.
| score on a scale | Infliximab | Rituximab | Tocilizumab | Placebo |
|---|---|---|---|---|
| Baseline | 2.5 (2 to 3) | 4 (2.5 to 4) | 4 (3.5 to 4.5) | 5 (5 to 5) |
| Day 120 | 3.5 (2.25 to 4.75) | 1.5 (1 to 2) | 1 (1 to 1.5) | 2 (2 to 2) |
| Day 240 | 1 (1 to 1.75) | 1 (1 to 1) | 1 (1 to 1) | 2 (2 to 2) |
| Day 360 | 1.5 (1 to 2.25) | 2 (2 to 3) | 1 (1 to 1) | 1 (1 to 1) |
| Day 480 | 2.5 (2.25 to 2.75) | 1 (1 to 2.5) | 1 (1 to 1) | 1 (1 to 1) |
| Day 600 | 1 (1 to 1) | 1 (1 to 1) | 1 (1 to 1) | 1 (1 to 1) |
| Day 720 | 0 (0 to 0) | 1 (1 to 1) | — | 1 (1 to 1) |
Serious adverse events (SAEs) and adverse events of special interest (AESI) (where infection is considered an AESI)
| Number of Events | Infliximab | Placebo | Rituximab | Tocilizumab |
|---|---|---|---|---|
| AESI | 21 | 2 | 17 | 0 |
| SAE | 0 | 0 | 7 | 0 |
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infliximab | 0/12 (0%) | 0/12 (0%) | 7/12 (58.3%) |
| Rituximab | 1/9 (11.1%) | 3/9 (33.3%) | 5/9 (55.6%) |
| Tocilizumab | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Placebo | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Infliximab | Rituximab | Tocilizumab | Placebo |
|---|---|---|---|---|
| TonsillitisInfections and infestations | 0/12 | 1/9 | 0/7 | 0/1 |
| PolychondritisMusculoskeletal and connective tissue disorders | 0/12 | 1/9 | 0/7 | 0/1 |
| Oral candidiasisInfections and infestations | 0/12 | 1/9 | 0/7 | 0/1 |
| vasculitis rashSkin and subcutaneous tissue disorders | 0/12 | 1/9 | 0/7 | 0/1 |
| Septic shockInfections and infestations | 0/12 | 1/9 | 0/7 | 0/1 |
| CellulitisInfections and infestations | 0/12 | 1/9 | 0/7 | 0/1 |
| Myocardial infarctionCardiac disorders | 0/12 | 1/9 | 0/7 | 0/1 |
| respiratory failureRespiratory, thoracic and mediastinal disorders | 0/12 | 0/9 | 0/7 | 0/1 |
| Event | Infliximab | Rituximab | Tocilizumab | Placebo |
|---|---|---|---|---|
| Covid-19Infections and infestations | 1/12 | 0/9 | 0/7 | 1/1 |
| Respiratory Tract InfectionInfections and infestations | 4/12 | 3/9 | 0/7 | 1/1 |
| Urinary Tract InfectionInfections and infestations | 3/12 | 4/9 | 0/7 | 0/1 |
| vulvovaginal candidiasisInfections and infestations | 0/12 | 2/9 | 0/7 | 0/1 |
| Ear InfectionInfections and infestations | 2/12 | 0/9 | 0/7 | 0/1 |
| Lower respiratory tract infectionInfections and infestations | 2/12 | 0/9 | 0/7 | 0/1 |
| E.Coli Urinary Tract InfectionInfections and infestations | 0/12 | 1/9 | 0/7 | 0/1 |
| InfectionInfections and infestations | 0/12 | 1/9 | 0/7 | 0/1 |
| Localised infectionInfections and infestations | 0/12 | 1/9 | 0/7 | 0/1 |
| Oral candidiasisInfections and infestations | 0/12 | 1/9 | 0/7 | 0/1 |
| Age, Categorical(Participants) | Rituximab | Infliximab | Tocilizumab | Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 1 | 0 | 0 | 0 | 1 |
| Between 18 and 65 years | 4 | 5 | 2 | 1 | 12 |
| >=65 years | 2 | 2 | 1 | 0 | 5 |
| Age, Continuous(years) | Rituximab | Infliximab | Tocilizumab | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 46.57 ± 25.55 | 48.57 ± 14.41 | 54.67 ± 21.2 | 58 ± 0 | 49.33 ± 19.22 |
| Sex: Female, Male(Participants) | Rituximab | Infliximab | Tocilizumab | Placebo | Total |
|---|---|---|---|---|---|
| Female | 6 | 6 | 2 | 1 | 15 |
| Male | 1 | 1 | 1 | 0 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Rituximab | Infliximab | Tocilizumab | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 7 | 3 | 1 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Rituximab | Infliximab | Tocilizumab | Placebo | Total |
|---|---|---|---|---|---|
| United Kingdom | 7 | 7 | 3 | 1 | 18 |
| Disease group(Participants) | Rituximab | Infliximab | Tocilizumab | Placebo | Total |
|---|---|---|---|---|---|
| Giant Cell Arteritis | 1 | 1 | 1 | 0 | 3 |
| Takayasu's Arteritis | 1 | 0 | 0 | 0 | 1 |
| Polyarteritis Nodosa | 1 | 0 | 1 | 0 | 2 |
| Relapsing Polychondritis | 2 | 3 | 0 | 0 | 5 |
| IgA vasculitis | 1 | 3 | 1 | 1 | 6 |
| Cogan's syndrome | 1 | 0 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2021 to primary completion in Nov 2023, 28 months.
Results were first posted in Jun 2025, 1 year 6 months after primary completion.
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Cambridge University Hospitals NHS Foundation Trust →