drugset / Trial / NCT03967925
Rituximab and Belimumab Combination Therapy in PR3 Vasculitis
Phase 2
Unknown
31 enrolled
Rachel Jones
GlaxoSmithKline · collabImperial College London · collabMedical Research Council · collabNewcastle University · collabUniversity College, London · collabUniversity of Cambridge · collabUniversity of Glasgow · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Mechanistic study to assess whether dual B-cell immunotherapy by co-administration of rituximab and belimumab will result in improvements in biological endpoints, functional outcomes and clinical status compared to rituximab with placebo.
Timeline
- Start
- 2019-02-01
- Primary completion
- 2023-04
- Completion
- 2023-11
Publications
- McClure ME, Gopaluni S, Wason J, Henderson RB, Van Maurik A, Savage CCO, Pusey CD, Salama AD, Lyons PA, Lee J, Mynard K, Jayne DR, Jones RB; on behalf the COMBIVAS investigators. A randomised study of rituximab and belimumab sequential therapy in PR3 ANCA-associated vasculitis (COMBIVAS): design of the study protocol. Trials. 2023 Mar 11;24(1):180. doi: 10.1186/s13063-023-07218-y.
- Serling-Boyd N, Wallace ZS. Management of primary vasculitides with biologic and novel small molecule medications. Curr Opin Rheumatol. 2021 Jan;33(1):8-14. doi: 10.1097/BOR.0000000000000756.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Belimumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Comparator | Prednisolone | Other / unclassified | 20 mg | — |
| Comparator | Rituximab | Monoclonal antibody | 1 g | Intravenous |