Rituximab and Belimumab for Lupus Nephritis
Summary
In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.
Timeline
- Start
- 2015-07-09
- Primary completion
- 2018-03-12
- Completion
- 2019-02-08
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (superiority test); Rituximab/Cyclophosphamide (RC) vs Rituximab/Cyclophosphamide/Belimumab (RCB); p = 0.58; Regression, Logistic; note: Two-sided test NCT02260934 ↗
registry analysis (superiority test); Rituximab/Cyclophosphamide (RC) vs Rituximab/Cyclophosphamide/Belimumab (RCB); p = 0.25; Regression, Logistic; note: Two-sided test. NCT02260934 ↗
registry analysis (superiority test); Rituximab/Cyclophosphamide (RC) vs Rituximab/Cyclophosphamide/Belimumab (RCB); p = 0.15; Regression, Logistic; note: Two-sided test. NCT02260934 ↗
Publications
- Results Atisha-Fregoso Y, Malkiel S, Harris KM, Byron M, Ding L, Kanaparthi S, Barry WT, Gao W, Ryker K, Tosta P, Askanase AD, Boackle SA, Chatham WW, Kamen DL, Karp DR, Kirou KA, Sam Lim S, Marder B, McMahon M, Parikh SV, Pendergraft WF 3rd, Podoll AS, Saxena A, Wofsy D, Diamond B, Smilek DE, Aranow C, Dall'Era M. Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis. Arthritis Rheumatol. 2021 Jan;73(1):121-131. doi: 10.1002/art.41466. Epub 2020 Dec 1.
- Yang Z, Liu S, Zong Z, Li Q, Yu L, Sun S. Treatment of thrombotic microangiopathy associated with systemic lupus erythematosus with low-dose rituximab as an induction agent and belimumab as a maintenance agent. BMC Pediatr. 2025 Feb 26;25(1):141. doi: 10.1186/s12887-025-05506-x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belimumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Acetaminophen | Small molecule | 650 mg | Oral |
| Background | Diphenhydramine | Small molecule | 50 mg | Oral |
| Background | Prednisone | Other / unclassified | 10 mg | — |
| Background | Week 0 and Week 2: Solumedrol (100 mg) IV | Unknown | 100 mg | Intravenous |