From: Next-generation anti-CD20 monoclonal antibodies in autoimmune disease treatment
Drug | Disease | Criteria | Study | Format | Status |
---|---|---|---|---|---|
Ocrelizumab | RA | Patients with inadequate response to MTX | Phase I/II [15] NCT02720120 | IV | Terminated |
RA | Japanese patients with inadequate response to MTX | Phase I/II [15] NCT00779220 | IV | Terminated early | |
RA | Patients with inadequate response to etanercept and adalimumab | Phase II [15] NCT00808210 | IV | Terminated | |
RA | Patients on MTX | ACTION, Phase I/II [13] NCT00077870 | IV | Completed | |
RA | Patients on MTX | STAGE, Phase III [9] NCT00406419 | IV | Terminated | |
RA | Patients on MTX | FILM, Phase III [10] NCT00485589 | IV | Terminated | |
RA | Patients with inadequate response to TNF antagonist | SCRIPT, Phase III [12] NCT00476996 | IV | Terminated | |
RA | Patients with inadequate response to MTX | FEATURE, Phase IIb [11] NCT00673920 | IV | Terminated | |
SLE | Patients with active SLE, but not LN | BEGIN, Phase IIINCT00539838 | IV | Terminated early | |
SLE | Patients with active LN | BELONG, Phase III [32] NCT00626197 | IV | Terminated early | |
RRMS | ≥ 2 relapses in the last 3 years with ≥ 1 in the past year and ≥ 6 T2 lesions per MRI, or 2 relapses in the last year | Phase II [24] NCT00676715 | IV | Completed | |
≥ 2 relapses in the last 2 years, 1 relapse in the last year, or MRI consistent with MS | OPERA I and II, Phase III [22] NCT01247324, NCT01412333 | IV | Approved | ||
PPMS | Patients meeting revised McDonald criteria and disease duration < 15 years if EDSS > 5.0, < 10 years if EDSS ≥ 5.0 | ORATORIO, Phase III [23] NCT01194570 | IV | Approved | |
RRMS | Patients meeting revised McDonald criteria, ≥ 1 release in last year, disease duration ≤ 3 years, EDSS ≤ 3.5 | Phase III NCT03085810 | IV | Recruiting | |
RRMS PPMS | Patients from OPERA I, OPERA II, or ORATORIO; clinically stable | Phase III NCT01765361 | IV | Completed | |
RRMS | Patients meeting revised McDonald criteria, EDSS ≤ 5.5, ≥ 1 immunization against TT, DT, or DTaP | Phase IIIB NCT02545868 | IV | Ongoing | |
RRMS | Patients meeting revised McDonald criteria, disease duration ≤ 12 years, suboptimal response to other DMT | Phase III NCT02637856 | IV | Recruiting | |
RRMS | Patients meeting revised McDonald criteria, disease duration ≤ 12 years, suboptimal response to other DMT | Phase III NCT02637856 | IV | Recruiting | |
Ofatumumab | RA | Patients with inadequate response to DMARDs | Phase I/II [18] NCT00291928 | IV | Completed |
RA | Biologically naïve patients who failed at least one DMARD | OFA111752, Phase II extension [17] NCT00655824 | IV | Terminated | |
RA | Biologically naïve patients who failed MTX | OFA110635, Phase III [16] NCT00611455 | IV | Terminated | |
RA | Biologically naïve patients who failed TNF antagonist | OFA110634, Phase III [17] NCT00603525 | IV | Terminated | |
RA | Patients who failed MTX | Phase I/II [19] NCT00686868 | SC | Completed | |
RRMS | ≥ 2 relapses in the last 2 years, or ≥ 1 relapse in the last 1–2 years and ≥ 1 T1 GEL in the last year | Phase II [25] NCT00640328 | IV | Completed | |
≥ 1 relapse in the last year, ≥ 2 relapses in the last 2 years, or ≥ 1 relapse in the last 2 years with GEL in the last year | MIRROR, Phase II [26] NCT01457924 | SC | Completed | ||
Patients with at least 1 relapse in the last year, 2 relapses in 2Â years, or GEL MRI in last year | ASCLEPIOS I and II, Phase III NCT02792218, NCT02792231 | SC | Recruiting | ||
Pemphigus vulgaris | Patients with moderate or severe disease who failed a steroid taper | Phase III NCT01920477, NCT02613910 | SC | Terminated | |
Obinutuzumab | SLE | Patients with active LN | Phase II NCT02550652 | IV | Recruiting |
Veltuzumab | RA | Patients who failed MTX alone or MTX plus TNF antagonist | VELVET, Phase II NCT01390545 | SC | Terminated redesigned |