Last reviewed · How we verify
NCT05868837: REFINE
Rituximab EfFicacy IN MyasthEnia Gravis (REFINE)
Phase 3 trial testing Rituximab in Myasthenia Gravis, Generalized in 40 participants. Currently enrolling.
31 July 2025
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 28 February 2022 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 July 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Rituximab — full drug profile →
- Placebo
Conditions studied
- Myasthenia Gravis, Generalized — all drugs for Myasthenia Gravis, Generalized →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with Myasthenia Gravis, Generalized. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this phase III trial is to investigate if Rituximab can reduce patients' functional impairment caused by MG. The secondary objectives of this trial are to assess whether treatment with rituximab in patients with MG will: * Allow faster and greater corticosteroid tapering * Reduce the frequency of exacerbations * Improve quality of life * Offer an acceptable safety and tolerability profile.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting autoimmune mechanisms by precision medicine in Myasthenia Gravis.
Cavalcante P, Mantegazza R, Antozzi C. · · 2024 · cited 19× · PMID 38903526 · DOI 10.3389/fimmu.2024.1404191 -
Novel therapies for myasthenia gravis: Translational research from animal models to clinical application.
Sorrenti B, Laurini C, Bosco L, Strano CMM, et al · · 2026 · cited 3× · PMID 40145986 · DOI 10.4103/nrr.nrr-d-24-01011 -
Delving into Molecular Pathways: Analyzing the Mechanisms of Action of Monoclonal Antibodies Integrated in IMGT/mAb-DB for Myasthenia Gravis.
Golfinopoulou R, Giudicelli V, Manso T, Kossida S. · · 2023 · cited 3× · PMID 38140161 · DOI 10.3390/vaccines11121756 -
Immunological Targets in Generalized Myasthenia Gravis Treatment: Where Are We Going Now?
Rossini E, Leonardi L, Morino S, Antonini G, et al · · 2025 · cited 1× · PMID 41008338 · DOI 10.3390/brainsci15090978
Verify or expand the search:
- PubMed search for NCT05868837
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Myasthenia Gravis, Generalized
Currently open trials in the same condition.
- NCT07072988 — Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC E · Phase 4 · recruiting
- NCT06909253 — Ravulizumab Treatment Outcomes in Patients With Generalized Myasthenia Gravis · recruiting
- NCT06455709 — Markers of Favorable Response to Complement Inhibitors Therapy · recruiting
- NCT04806620 — Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research · recruiting
- NCT05067348 — Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis · Phase 2 · recruiting
Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials
Trials by the same sponsor.
- NCT07514572 — Impact of Estimated Weight and Height on Nutritional Assessment in Elderly · NA · not yet recruiting
- NCT07504679 — Adipose Visceral and Epicardial Risk Evaluation · NA · not yet recruiting
- NCT07520643 — MISTIC Study: Atherosclerosis, Neurocognition & Cardiovascular Signaling · not yet recruiting
- NCT07479238 — Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy · not yet recruiting
- NCT07494227 — Development of the SC-IBD Self-Care Measurement Scale · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05868837 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 1 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05868837.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing