A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-07-31

Brief Summary

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This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.

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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 for a total of 6 infusions

methotrexate

Intervention Type DRUG

10-25 mg orally weekly

Interventions

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tocilizumab [RoActemra/Actemra]

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

Intervention Type DRUG

methotrexate

10-25 mg orally weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Moderate to severe active rheumatoid arthritis (RA) of \>/= 6 months duration
* Prior treatment with DMARDs for \>/= 12 weeks (at stable dose for \>/= 8 weeks)
* Inadequate clinical response to stable dose of non-biologic DMARD (either single or in combination)

Exclusion Criteria

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Autoimmune disease other than RA
* History of or current inflammatory joint disease other than RA
* Previous treatment with any biologic drug that is used in the treatment of RA
* Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
* Impaired liver, renal or hematologic function
* Active current or history of recurrent infection
* History of or currently active primary or secondary immunodeficiency

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No