A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

Roche

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: tocilizumab [RoActemra/Actemra]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010503

2009-011520-53

ML22508

Details and patient eligibility

About

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >/= 18 years of age
• moderate to severe active rheumatoid arthritis
• inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
• DAS >3.6
• pneumology examination (including chest x-ray and quantiferon)

Exclusion criteria

• < 18 years of age
• active infection
• active tuberculosis
• uncontrolled hyperlipoproteinaemia
• demyelinating disorders
• concomitant anti-TNF drugs
• history of intestinal ulceration and diverticulitis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]