A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

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This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab \[RoActemra/Actemra\] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type DRUG

8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions

Interventions

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tocilizumab [RoActemra/Actemra]

8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>/=18 years of age
* moderate to severe rheumatoid arthritis (DAS28 \>3.2) of 6 months duration
* inadequate clinical response to non-biologic DMARDs or anti-TNF
* bodyweight \</=150 kg

Exclusion Criteria

* rheumatic autoimmune disease or inflammatory joint disease other than RA
* major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No