A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-08-31

Brief Summary

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This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).

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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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Single Arm

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type DRUG

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

Interventions

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tocilizumab [RoActemra/Actemra]

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Moderate to severe active rheumatoid arthritis (DAS28 \> 3.2 at screening)
* Inadequate response to DMARDs
* Body weight \< 150 kg

Exclusion Criteria

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment
* Rheumatic autoimmune disease other than RA
* American College of Rheumatology (ACR) functional class IV
* Prior history of or current inflammatory joint disease other than RA
* Previous treatment with any biologic drug that is used in the treatment of RA
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Pregnant or lactating women
* Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No