A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488

NCT ID: NCT01715831

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-15
• Study Completion Date: 2016-06-06

Brief Summary

This multicenter, open-label, single-arm extension study will evaluate the long-term safety of tocilizumab (RoActemra/Actemra) in participants with RA. Participants who have completed the MA21488 (NCT00810199) core study and the ML21530 (NCT00754572) study and who could benefit from the study drug, according to the opinion of the investigator, will receive 8 milligrams per kilogram (mg/kg) of intravenous (IV) tocilizumab every 4 weeks. The anticipated time on study treatment is 104 weeks.

Conditions

Arthritis, Rheumatoid

Study Design

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

Study Groups

Tocilizumab

Participants will receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant will be of 800 mg of tocilizumab. Participants may also receive disease-modifying anti-rheumatic drugs (DMARDs) in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.

Group Type: EXPERIMENTAL

DMARDs

Intervention Type: DRUG

DMARDs may be added to the tocilizumab treatment in any visit, at the discretion of the investigator, according to the local prescription information and participant's tolerance. Study protocol does not specify any particular DMARD.

Tocilizumab

Intervention Type: DRUG

Tocilizumab will be administered at 8 mg/kg IV dose every 4 weeks for 104 weeks

Interventions

DMARDs

DMARDs may be added to the tocilizumab treatment in any visit, at the discretion of the investigator, according to the local prescription information and participant's tolerance. Study protocol does not specify any particular DMARD.

Intervention Type: DRUG

Tocilizumab

Tocilizumab will be administered at 8 mg/kg IV dose every 4 weeks for 104 weeks

Intervention Type: DRUG

Other Intervention Names

RoActemra; Actemra

Eligibility Criteria

Inclusion Criteria

• Participants who have completed their last visit in the core studies ML21530 and MA21488 and that might benefit from treatment using the study drug according to the investigator's evaluation
• Absence of an AE or current or recent laboratory finding that would prevent the use of the 8 mg/kg dose of the tocilizumab
• Receiving outpatient treatment
• For women who are not postmenopausal and are not surgically sterile: agreement to use at least one adequate method of contraception

Exclusion Criteria

• Participants who have prematurely discontinued the core studies ML21530 and MA21488 for any reason
• MA21488 study participants who remained untreated with tocilizumab after it's discontinuation according to the treatment-free remission criteria of MA21488 study
• Immunization with a live/attenuated vaccine since the last administration of the study drug in the core studies ML21530 and ML21488
• Diagnosis after the last visit of the study ML21530 or after the last visit of the study MA21488 of a rheumatic autoimmune disease other than RA, including systemic erythematous lupus (SEL), mixed connective tissue disease (MCTD), scleroderma and polymyositis, or a significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjogren's Syndrome and/or nodulosis with RA are allowed
• Diagnosis after the last visit of the core study ML21530 or of the study MA21488 of an inflammatory joint disease other than RA
• Abnormal laboratory parameters at the baseline
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• Evidences of a concomitant, serious and uncontrolled illness
• Known active condition or a history of recurrent infections by bacteria, viruses, fungi, mycobacteria or other agents
• Evidence of an active malignant disease, malignancies diagnosed in the last 10 years or breast cancer diagnosed in the last 20 years
• Uncontrolled disease status, such as asthma or inflammatory bowel disease in which acute crises are usually treated with oral or parenteral corticosteroids
• Current hepatic disease, as determined by the investigator
• Active tuberculosis (TB) requiring treatment in the previous three years. Participants should be screened for latent TB according to local practice guidelines and should not be admitted into the study if latent TB is detected. Participants must not present any evidence of active TB infection at the enrollment. Participants treated for tuberculosis without recurrence in three years are allowed
• History of alcohol, drugs or chemical abuse since the inclusion in the core studies ML21530 and MA21488

• 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

Hospital Universitario Cassiano Antonio Moraes - UFES; Reumatologia

Vitória, Espírito Santo, Brazil

Santa Casa de Misericordia de Salvador; Reumatologia

Salvador, Estado de Bahia, Brazil

Centro Mineiro de Pesquisa - CMIP

Juiz de Fora, Minas Gerais, Brazil

Hospital das Clinicas - UNICAMP

Campinas, São Paulo, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Universidade Federal de Sao Paulo - UNIFESP; Reumatologia

São Paulo, São Paulo, Brazil

Hospital Abreu Sodre - AACD;Reumatologia

São Paulo, São Paulo, Brazil

Hospital Estadual do Servidor Publico; Reumatologia

São Paulo, São Paulo, Brazil

Centro Paulista de Investigacao Clinica - CEPIC

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

ML28091

Identifier Type: -

Identifier Source: org_study_id