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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01715831
First received: October 25, 2012
Last updated: September 14, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Arthritis, Rheumatoid
Drug: Disease-modifying anti-rheumatic drugs (DMARDs)
Drug: Tocilizumab
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adverse Events Leading to Dose Modification or Study Discontinuation [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adverse Events of Special Interest [ Time Frame: Approximately 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Disease Activity Index 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at specified time points [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Tender Joint Count (TJC) at specified time points [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Swollen Joint Count (SJC) at specified time points [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline Score for Global Evaluation of Disease Activity by the Patient Using Visual Analog Scale (VAS) at specified time points [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline Score for Global Evaluation of Disease Activity by the Physician Using VAS at specified time points [ Time Frame: From Baseline to Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104 and four follow up visits every 4 week after Week 104 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline Score for Participant's Pain Assessment Using VAS at specified time points [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline Score for Health Assessment Questionnaire - Disability Index (HAQ - DI) at specified time points [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Means Change From Baseline in C-Reactive Protein (CRP) Level at specified time points [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Means Change From Baseline in Erythrocyte Sedimentation Rate at specified time points [ Time Frame: 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) ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tocilizumab Arm
Participants will receive an IV tocilizumab infusion of 8 mg/kg 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.
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.
Drug: Tocilizumab
Tocilizumab will be administered 8 mg/kg IV dose every 4 weeks for 104 weeks
Other Name: RoActemra/Actemra

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715831

Locations
Brazil
Salvador, BA, Brazil, 40050-410
Vitoria, ES, Brazil, 29043-910
Juiz de Fora, MG, Brazil, 36036-330
Campinas, SP, Brazil, 13083-888
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Sao Paulo, SP, Brazil, 04026-000
Sao Paulo, SP, Brazil, 04027-000
Sao Paulo, SP, Brazil, 04039-004
Sao Paulo, SP, Brazil, 04266-010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01715831     History of Changes
Other Study ID Numbers: ML28091 
Study First Received: October 25, 2012
Last Updated: September 14, 2016
Health Authority: Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2016