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Table 2 Randomized controlled trials of next-generation anti-CD20 mAbs in autoimmune diseases

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 2 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