drugset / Trial / NCT01946880
Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)
Phase 2
Terminated
102 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence · collabRho Federal Systems Division, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.
Timeline
- Start
- 2013-11-20
- Primary completion
- 2019-07-03
- Completion
- 2019-07-03
Outcome
Met primary endpoint
Stopped (Enrollment): “Slow enrollment.”
paper INTERPRETATIONS: Mycophenolate mofetil withdrawal is not significantly inferior to mycophenolate mofetil maintenance. PMID 38301682 ↗
Publications
- Chakravarty EF, Utset T, Kamen DL, Contreras G, McCune WJ, Aranow C, Kalunian K, Massarotti E, Clowse MEB, Rovin BH, Lim SS, Majithia V, Dall'Era M, Looney RJ, Erkan D, Saxena A, Olsen NJ, Ko K, Guthridge JM, Goldmuntz E, Springer J, D'Aveta C, Keyes-Elstein L, Barry B, Pinckney A, McNamara J, James JA. Mycophenolate mofetil withdrawal in patients with systemic lupus erythematosus: a multicentre, open-label, randomised controlled trial. Lancet Rheumatol. 2024 Mar;6(3):e168-e177. doi: 10.1016/S2665-9913(23)00320-X. Epub 2024 Jan 29.
- Wenderfer SE, Eldin KW. Lupus Nephritis. Pediatr Clin North Am. 2019 Feb;66(1):87-99. doi: 10.1016/j.pcl.2018.08.007.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 1000 mg | — |
| Subject | Mycophenolate Mofetil | Small molecule | 3000 mg | — |
| Background | Chloroquine | Small molecule | — | — |
| Background | Hydroxychloroquine | Small molecule | — | — |
| Background | Prednisone | Other / unclassified | — | — |