COMBIVAS: A trial of rituximab versus rituximab and belimumab for time to remission in ANCA vasculitis

Phase 1

Active, not recruiting

• Conditions: ANCA-associated vasculitis; MedDRA version: 20.1 Level: PT Classification code 10050894 Term: Anti-neutrophil cytoplasmic antibody positive vasculitis System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-004645-24-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-20
• Last Update Posted: 2019-06-30

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
1. Participant must be =18 of age at the time of signing the informed consent form.
Participants who have:
2. Have a diagnosis of AAV [granulomatosis with polyangiitis or microscopic polyangiitis]
3. Have PR3 ANCA positivity by ELISA at screening
4. Have active disease defined by one major or three minor disease activity items on BVAS/WG
5. Be capable of giving signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. MPO ANCA or anti–GBM antibody positivity by ELISA
2. Presence of pulmonary haemorrhage with hypoxia at screening
3. Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 at screening
4. Have an acute or chronic infection at screening
5. Have received any B cell targeted therapy within 364 days of Day 1
6. Have received cyclophosphamide within 180 days of Day 1
7. Have received any steroid injection between 60 days of Day 1 and 14 days of screening (e.g., intramuscular [IM], intraarticular, or IV)
8. Have received oral prednisolone >10mg/day (or equivalent) on average over the 30 days prior to screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified