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A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

NCT ID: NCT01251120

Last Updated: 2014-11-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-01-31

Brief Summary

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This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 intravenously every 4 weeks plus background DMARDs (including methotrexate)

2

Group Type ACTIVE_COMPARATOR

DMARD

Intervention Type DRUG

Non-biologic DMARDs (including methotrexate) according to current best practice

Interventions

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tocilizumab [RoActemra/Actemra]

8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate)

Intervention Type DRUG

DMARD

Non-biologic DMARDs (including methotrexate) according to current best practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, over the age of 18 years
* Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
* DAS28 \>3.2
* Swollen joint count (SJC) \>/=6 (66 joint count), and tender joint count (TJC) \>/=6 (68 joint count)
* Patients who have received DMARDs (including methotrexate) for 3-7 months

Exclusion Criteria

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
* Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
* Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
* Prior history of or current inflammatory joint disease other than RA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Hämeenlinna, , Finland

Site Status

Helsinki, , Finland

Site Status

Jyväskylä, , Finland

Site Status

Kuopio, , Finland

Site Status

Riihimäki, , Finland

Site Status

Rovaniemi, , Finland

Site Status

Countries

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Finland

Other Identifiers

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ML25346

Identifier Type: -

Identifier Source: org_study_id