An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment

NCT ID: NCT01254331

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-02-28

Brief Summary

This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Group Type: EXPERIMENTAL

tocilizumab [RoActemra]

Intervention Type: DRUG

tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions

Interventions

tocilizumab [RoActemra]

tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients >/=18 years of age
• Moderate to severe rheumatoid arthritis defined as DAS 28>3.2
• Body weight </=150 kg
• Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
• Inadequate clinical response to a stable dose of a non-biologic DMARD

Exclusion Criteria

• Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
• Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
• Functional class IV as defined by the ACR classification
• History or current inflammatory joint disease other than RA
• Previous treatment with any cell depleting therapy
• Previous treatment with methotrexate
• Previous treatment with tocilizumab
• Previous treatment with any biologic drug that is used in the treatment of RA

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Sfax, , Tunisia

Sousse, , Tunisia

Tunis, , Tunisia

Tunis, , Tunisia

Tunis, , Tunisia

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

ML22642

Identifier Type: -

Identifier Source: org_study_id