Clinical trial NCT00673920: A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
Official title: A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given As a Single Infusion or Dual Infusion Compared With Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
Conditions: Rheumatoid Arthritis
Summary: This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.
Interventions:
description: Oral or parenteral repeating dose
name: Methotrexate
type: Drug
description: Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).<br/>Ocrelizumab was administered in combination with Methotrexate.
name: Ocrelizumab
type: Drug
description: Intravenous repeating dose
name: Placebo
type: Drug
Study arms:
design_group_description: Participants received matching placebo:<br/>* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)<br/>* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
design_group_title: Ocrelizumab 400mg
design_group_type: Experimental
design_group_description: Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
design_group_title: Ocrelizumab 200mg
design_group_type: Experimental
design_group_description: Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
design_group_title: Ocrelizumab 200mg/ Ocrelizumab 200mg
design_group_type: Experimental
design_group_description: Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
design_group_title: Ocrelizumab 200mg/ Ocrelizumab 400mg
design_group_type: Experimental
design_group_description: Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
design_group_title: Ocrelizumab 400mg/ Ocrelizumab 400mg
design_group_type: Experimental
design_group_description: Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
design_group_title: Placebo/ Ocrelizumab 200mg
design_group_type: Experimental
design_group_description: Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
design_group_title: Placebo/ Ocrelizumab 400mg
design_group_type: Experimental
Sponsor: Genentech, Inc.
Collaborators: Roche Pharma AG
Drug name mappings:
name: 奥瑞利珠单抗
lang: CN
name: Ocrelizumab
lang: EN
name: 甲氨蝶呤钠
lang: CN
name: Methotrexate Sodium
lang: EN