Table 2.

Clinical trials of mavrilimumab in rheumatoid arthritis

Study (trial registration number)	Trial phase	Drug regimen	Length	Primary end point	References
NCT00771420	Phase I	Single, escalating intravenous doses of mavrilimumab (0.01, 0.03, 0.1, 0.3, 1.0, 3.0, and 10.0 mg/kg) or placebo, plus MTX	24 weeks of follow-up after the infusion	Incidence and severity of adverse events	55
EARTH study (NCT01050998)	Phase IIa	10, 30, 50, or 100 mg SC mavrilimumab eow or placebo, plus MTX	12 weeks of active treatment and 12 weeks of follow-up	Improvement in DAS28-CRP at 12 weeks	56
EARTH (Japan) study (NCT01050998)	Phase IIa	10, 30, 50, or 100 mg SC mavrilimumab eow or placebo, plus MTX	12 weeks of active treatment and 12 weeks of follow-up	Improvement in DAS28-CRP at 12 weeks	57
EARTH EXPLORER 1 (NCT01706926)	Phase IIb	150, 100, 30 mg SC mavrilimumab eow or placebo, plus MTX	24 weeks	Improvement in DAS28-CRP at day 85 and ACR20 response rate at day 169	61
EARTH EXPLORER 2 (NCT01715896)	Phase IIb	Mavrilimumab 100 mg SC eow or golimumab 50 mg SC monthly alternating with placebo, plus MTX	24 weeks	ACR20, 50, 70 responses rates at 24 weeks, proportion of patients achieving DAS28 <2.6, HAQ-DI improvement >0.25	62
OPEN-LABEL EXTENSION* (NCT01712399)	Phase II (open-label extension)	Mavrilimumab 100 mg SC eow plus MTX	122 weeks	Incidence and severity of adverse events	64

Note:

^*Open-label extension study enrolled RA patients who had completed the EARTH EXPLORER 1 and 2.

Abbreviations: ACR, American College of Rheumatology; CRP, C-reactive protein; DAS28, disease activity score-28; eow, every other week; HAQ-DI, Health Assessment Questionnaire Disability Index; MTX, methotrexate; SC, subcutaneous.