A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Roche

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Ocrelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02720120

2004-002132-26 (EudraCT Number)

WA18230

Details and patient eligibility

About

This study is in two parts and will evaluate the safety, tolerability and efficacy of escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation study, at one of the following dose levels of ocrelizumab [400, 1000, 1500, and 2000 milligrams (mg)]. In Part 2, participants will be randomized to explore tolerability and efficacy of doses which have been shown to be tolerated in Part 1.

Enrollment: 175 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe RA for at least 6 months
• Positive serum rheumatoid factor (>/= 20 international units per milliliter)
• Current treatment with RA on an outpatient basis
• Treatment failure with one disease modifying anti-rheumatic drug (DMARD) or biologic, but have not failed more than six of these agents including methotrexate
• Current treatment with methotrexate for at least 12 weeks, at a stable dose
• Use of highly effective contraception.

Exclusion criteria

• Rheumatic autoimmune disease or inflammatory joint disease, other than RA
• Concurrent treatment with any disease-modifying anti-rheumatic drug (DMARD) (other than methotrexate) or any anti-tumor necrosis factor (TNF) -alfa or other biologic therapy
• Treatment with any other investigational drug within 4 weeks of screening
• Previous treatment with cell-depleting therapies, IV gamma-globulin, intra-articular or parenteral corticosteroids, and receipt of live/attenuated vaccine prior to screening
• Previous treatment with rituximab or any other anti-cluster of differentiation 20 (CD20) agent
• History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies
• Known active bacterial, viral or fungal infections
• History of active tuberculosis and primary or secondary immunodeficiency
• History of concomitant diseases such as cardiovascular disease, nervous system, pulmonary disease, renal, hepatic, endocrine or gastrointestinal disorders
• Pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 8 patient groups, including a placebo group

Part 1: Ocrelizumab 1000 mg

Experimental group

Description:

Participants will receive single IV infusion of ocrelizumab 1000 mg.

Treatment:

Drug: Ocrelizumab

Part 1: Ocrelizumab 1500 mg

Experimental group

Description:

Participants will receive single IV infusion of ocrelizumab 1500 mg.

Treatment:

Drug: Ocrelizumab

Part 1: Ocrelizumab 2000 mg

Experimental group

Description:

Participants will receive single IV infusion of ocrelizumab 2000 mg.

Treatment:

Drug: Ocrelizumab

Part 1: Ocrelizumab 400 mg

Experimental group

Description:

Participants will receive single IV infusion of ocrelizumab 400 milligrams (mg)

Treatment:

Drug: Ocrelizumab

Part 1: Placebo

Placebo Comparator group

Description:

Participants will receive single IV infusion of placebo matched to ocrelizumab.

Treatment:

Drug: Placebo

Part 2: Ocrelizumab 1000 mg

Experimental group

Description:

Participants will receive single IV infusion of ocrelizumab 1000 mg.

Treatment:

Drug: Ocrelizumab

Part 2: Ocrelizumab 1500 mg

Experimental group

Description:

Participants will receive single IV infusion of ocrelizumab 1500 mg.

Treatment:

Drug: Ocrelizumab

Part 2: Ocrelizumab 400 mg

Experimental group

Description:

Participants will receive single IV infusion of ocrelizumab 400 mg.

Treatment:

Drug: Ocrelizumab