A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With RA Having Completed the Studies ML21530 And MA21488

Arthritis, Rheumatoid Clinical Trial

Official title:

A Multicenter, Open-Label, Single-Arm Extension Study To Describe The Safety Of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 And MA21488 And Presenting An Indication Of Maintaining The Tocilizumab Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715831
• Other study ID #: ML28091
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2012
• Last updated: November 1, 2016
• Start date: January 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
• Study type: Interventional

Clinical Trial Summary

This multicenter, open-label, single-arm extension study will evaluate the long-term safety of tocilizumab (RoActemra/Actemra) in participants with Rheumatoid Arthritis (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 milligram per kilogram (mg/kg) of intravenous (IV) tocilizumab every 4 weeks. The anticipated time on study treatment is 104 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants who have completed their last visit ML21530 and MA21488 in core studies and that might benefit from treatment using the study drug according to the investigator's evaluation

• Absence of an adverse event (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 ML21530 and MA21488 core studies for any reason

• MA21488 study participants who remained untreated with tocilizumab after it's discontinuation according to the treatment-free remission criteria from MA21488 study

• Immunization with a live/attenuated vaccine since the last administration of the study drug in ML21530 and ML21488 core studies

• 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 in ML21530 study or after the last visit in MA21488 study of a rheumatic autoimmune disease and/or an inflammatory joint disease other than rheumatoid arthritis

• 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 drugs of abuse since the inclusion in the ML21530 and MA21488 core studies

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Disease-modifying anti-rheumatic drugs (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.
• Tocilizumab
Tocilizumab will be administered 8 mg/kg IV dose every 4 weeks for 104 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events		Approximately 3 years	No
Primary	Percentage of Participants With Adverse Events Leading to Dose Modification or Study Discontinuation		Approximately 3 years	No
Primary	Percentage of Participants With Adverse Events of Special Interest		Approximately 3 years	Yes
Secondary	Mean Change From Baseline in Disease Activity Index 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at specified time points		From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104 (up to approximately 3 years)	No
Secondary	Mean Change From Baseline in Tender Joint Count (TJC) at specified time points		From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104 (up to approximately 3 years)	No
Secondary	Mean Change From Baseline in Swollen Joint Count (SJC) at specified time points		From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104 (up to approximately 3 years)	No
Secondary	Mean Change From Baseline Score for Global Evaluation of Disease Activity by the Patient Using Visual Analog Scale (VAS) at specified time points		From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104 (up to approximately 3 years)	No
Secondary	Mean Change From Baseline Score for Global Evaluation of Disease Activity by the Physician Using VAS at specified time points		From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104	No
Secondary	Mean Change From Baseline Score for Participant's Pain Assessment Using VAS at specified time points		From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104 (up to approximately 3 years)	No
Secondary	Mean Change From Baseline Score for Health Assessment Questionnaire - Disability Index (HAQ - DI) at specified time points		From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104 (up to approximately 3 years)	No
Secondary	Means Change From Baseline in C-Reactive Protein (CRP) Level at specified time points		From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104 (up to approximately 3 years)	No
Secondary	Means Change From Baseline in Erythrocyte Sedimentation Rate at specified time points		From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104 (up to approximately 3 years)	No