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A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

NCT ID: NCT00996203

Last Updated: 2018-03-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-02-14

Brief Summary

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This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

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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 every 4 weeks for 24 weeks

DMARDs (disease-modifying antirheumatic drugs)

Intervention Type DRUG

stable doses at investigator's prescription

Interventions

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tocilizumab [RoActemra/Actemra]

8 mg/kg iv every 4 weeks for 24 weeks

Intervention Type DRUG

DMARDs (disease-modifying antirheumatic drugs)

stable doses at investigator's prescription

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>/= 18 years of age
* moderate to severe active rheumatoid arthritis of \>/=6 months duration
* inadequate clinical response to current non-biologic DMARDs
* current DMARDs must be at stable dose for 8 weeks prior to study entry
* oral corticosteroids (\</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for \>/=4 weeks prior to screening

Exclusion Criteria

* rheumatic autoimmune disease other than RA
* history of or current inflammatory joint disease other than RA
* previous treatment with any biologic DMARD
* functional class IV as defined by the ACR classification
* intra-articular or parenteral corticosteroids within 6 weeks prior to screening
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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Chelyabinsk Regional Clinical Hospital; Rheumatology

Chelyabinsk, , Russia

Site Status

Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department

Cherkess, , Russia

Site Status

Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise

Irkutsk, , Russia

Site Status

Republican Clinicodiagnostic Center

Izhevsk, , Russia

Site Status

Kaliningrad Regional Clinical Hospital; Rheumatologic Department

Kaliningrad, , Russia

Site Status

War Veterans Regional Clinical Hospital;Therapy Department

Kemerovo, , Russia

Site Status

Kirov Regional Clinical Hospital; Reumatology Department

Kirov, , Russia

Site Status

GUZ Regional clinical hospital # 1

Krasnodar, , Russia

Site Status

GMU Kursk regional clinical hospital

Kursk, , Russia

Site Status

FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

Moscow, , Russia

Site Status

FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"

Moscow, , Russia

Site Status

FGU Central Clinical Hospital with Polyclinic Administration President RF

Moscow, , Russia

Site Status

Head Clinical Hospital of Internal Affair Ministry of Russia

Moscow, , Russia

Site Status

Vladimirskiy Regional Scientific Research Inst.

Moscow, , Russia

Site Status

SIH Nizhny Novgorod Regional Clinical Hospital n.a. Semashko

Nizhny Novgorod, , Russia

Site Status

Republican Hospital Named After V.A. Baranov

Petrozavodsk, , Russia

Site Status

Rostov State Medical University; Cardiorheumatology Department

Rostov-on-Don, , Russia

Site Status

Clinical hospital #1

Smolensk, , Russia

Site Status

Surgut Region Clinical Hospital

Surgut, , Russia

Site Status

Glpu Tjumen Regional Clinical Hospital #1

Tyumen, , Russia

Site Status

Republican clinical hospital named after G.G. Kuvatov

Ufa, , Russia

Site Status

State Institution of Healthcare Ulyanovsk Regional Clinical Hospital

Ulyanovsk, , Russia

Site Status

GUZ "Novgorod Regional Clinical Hospital"; Cardioreumatological

Veliky Novgorod, , Russia

Site Status

Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

Voronezh, , Russia

Site Status

Voronezh Regional Clinical Hospital #1

Voronezh, , Russia

Site Status

SHI Yaroslavl Regional Clinical Hospital

Yaroslavl, , Russia

Site Status

Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"

Yekaterinburg, , Russia

Site Status

Sverdlovsk Regional Clinical Hospital # 1; Rheumatology Dept

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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ML22665

Identifier Type: -

Identifier Source: org_study_id

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