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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