drugset / Trial / NCT03514979
Acquired Immunodeficiency in ANCA Associated Vasculitis
Phase 2
Unknown
124 enrolled
Cambridge University Hospitals NHS Foundation Trust
Arthritis Research UK · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This study will address the following hypothesis: Rituximab therapy leads to an acquired immune deficiency, as demonstrated by impaired vaccine responses, in AAV patients. Aims: 1. To investigate whether rituximab leads to immune deficiency in patients with AAV when compared to both disease and healthy controls. 2. To investigate whether the degree of immune deficiency is associated with the degree of B cell depletion. 3. To investigate whether T-independent vaccine responses are more severely affected than T-dependent vaccine responses after rituximab and whether a conjugated vaccine will overcome this postulated deficit in T independent vaccine responses.
Timeline
- Start
- 2018-06
- Primary completion
- 2020-07
- Completion
- 2021-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pneumococcal Polysaccharide Conjugate vaccination | Vaccine | — | — |
| Subject | Pneumococcal Polysaccharide Vaccination | Vaccine | — | — |