A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)

NCT ID: NCT02010216

Last Updated: 2014-09-25

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-07-31

Brief Summary

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This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tocilizumab [RoActemra/Actemra]

Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type DRUG

8 mg/kg by intravenous infusion every 4 weeks

Interventions

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tocilizumab [RoActemra/Actemra]

8 mg/kg by intravenous infusion every 4 weeks

Intervention Type DRUG

Other Intervention Names

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RoActemra/Actemra

Eligibility Criteria

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Inclusion Criteria

* Adult patients, ≥ 18 years of age
* Confirmed moderate or severe rheumatoid arthritis
* Intolerability or absence of effect or decrease in effect of rheumatoid arthritis treatment with disease modifying antirheumatic drugs (DMARDs)

Exclusion Criteria

* Presence of infectious diseases \[tuberculosis (Tb), human immunodeficiency virus (HIV), virus hepatitis A/B/C\]
* Inadequate hematologic, renal or liver function
* Peptic ulcer disease (in acute phase)
* Pregnant and lactating women
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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Almaty, , Kazakhstan

Site Status

Astana, , Kazakhstan

Site Status

Astana, , Kazakhstan

Site Status

Shymkent, , Kazakhstan

Site Status

Shymkent, , Kazakhstan

Site Status

Ust-Kamenogorsk, , Kazakhstan

Site Status

Countries

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Kazakhstan

Other Identifiers

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ML23037

Identifier Type: -

Identifier Source: org_study_id

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