Rituximab and Belimumab Combination Therapy in PR3 Vasculitis (COMBIVAS)
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ClinicalTrials.gov Identifier: NCT03967925 |
Recruitment Status :
Active, not recruiting
First Posted : May 30, 2019
Last Update Posted : March 8, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
ANCA Associated Vasculitis Granulomatosis With Polyangiitis | Drug: Belimumab Drug: Rituximab Drug: Prednisolone | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated Vasculitis |
Actual Study Start Date : | February 1, 2019 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | November 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Belimumab
Weekly 200mg SC injections of belimumab for 12 months
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Drug: Belimumab
Sub-cutaneous injection
Other Name: Benlysta Drug: Rituximab IV infusion 1g x 2
Other Name: Truxima Drug: Prednisolone 20mg prednisolone tapering dose
Other Name: prednisone |
Placebo Comparator: Belimumab placebo
Weekly SC injections of belimumab placebo for 12 months
|
Drug: Rituximab
IV infusion 1g x 2
Other Name: Truxima Drug: Prednisolone 20mg prednisolone tapering dose
Other Name: prednisone |
- Time to PR3 ANCA negativity [ Time Frame: Analysed at 24 months ]ELISA analysis at different time points to determine when PR3 ANCA can no longer be detected
- Proportion of participants with PR3 ANCA negativity [ Time Frame: 2 years ]Measured by ELISA at various time points
- Change from baseline of certain cell subsets [ Time Frame: 2 years ]Measured by flow cytometry at various time points
- Time to clinical remission [ Time Frame: 2 years ]Measured by BVAS/WG
- Incidence of serious adverse events (SAEs) [ Time Frame: 2 years ]Hospitalisation or serious events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants must be 18 of age
- Have a diagnosis of AAV (granulomatosis with polyangiitis or microscopic polyangiitis)
- Have PR3 ANCA positivity by ELISA at screening
- Have active disease defined by one major or three minor disease activity items on BVAS/WG
- Be capable of giving signed informed consent
Exclusion Criteria:
- MPO ANCA or anti-GBM antibody positivity by ELISA at screening
- Presence of pulmonary haemorrhage with hypoxia at screening
- Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 at screening
- Have an acute serious or chronic infection at screening
- Have received any B cell targeted therapy within 364 days of Day 1
- Have received any steroid injection (e.g., intramuscular [IM], intraarticular, or IV) within 60 days of Day 1 (unless given during or 14 days before screening period)
- Have received >1.5mg methylprednisolone (IV) between 14 days prior to screening and Day 1 (including Day 1).
- Have received oral prednisolone >10mg/day (or equivalent) on average over the 30 days prior to screening
- Have undetectable peripheral blood B cells at screening
- Have IgG <400mg/dl at screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967925
United Kingdom | |
Addenbrooke's Hospital | |
Cambridge, United Kingdom | |
Glasgow Royal Infirmary | |
Glasgow, United Kingdom | |
Imperial College London | |
London, United Kingdom | |
Royal Free Hospital | |
London, United Kingdom | |
Royal Freemann Hospital | |
Newcastle, United Kingdom | |
Nottingham University Hospitals | |
Nottingham, United Kingdom |
Principal Investigator: | Rachel B Jones | Addenbrookes Hospital |
Responsible Party: | Rachel Jones, Consultant Nephrologist, Cambridge University Hospitals NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT03967925 |
Other Study ID Numbers: |
206852 |
First Posted: | May 30, 2019 Key Record Dates |
Last Update Posted: | March 8, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
proteinase 3 |
Granulomatosis with Polyangiitis Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Vascular Diseases Cardiovascular Diseases Systemic Vasculitis Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Autoimmune Diseases Immune System Diseases Prednisone Prednisolone |
Rituximab Belimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Immunosuppressive Agents |