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A Long-term Safety Extension Study in Patients With Rheumatoid Arthritis Having Completed the Studies ML21530 And MA21488

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01715831
First received: October 25, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

This multicenter, open-label, single-arm extension study will evaluate the long-term safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients who have completed the MA21488 core study and the ML21530 study and who could benefit from the study drug, according to the opinion of the investigator, will receive 8 mg/kg of intravenous RoActemra/Actemra every four weeks. The anticipated time on study treatment is 104 weeks.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:
  • Long-term Safety: Incidence of adverse events [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Disease Activity Index 28-Erythocyte Sedimentation Rate (DAS28-ESR) [ Time Frame: From baseline to approximately 2 years ] [ Designated as safety issue: No ]
  • Change in tender joint count (TJC) [ Time Frame: From baseline to approximately 2 years ] [ Designated as safety issue: No ]
  • Change in swollen joint count (SJC) [ Time Frame: From baseline to approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: January 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RoActemra/Actemra Single Arm Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks for 104 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients that 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 RoActemra/Actemra study drug
  • 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:

  • Patients who have prematurely discontinued ML21530 and MA21488 core studies for any reason
  • MA21488 study patients 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 MA 21488 core studies
  • 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
  • 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

Contacts
Contact: Reference Study ID Number: ML28091 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Brazil
Active, not recruiting
Salvador, BA, Brazil, 40050-410
Active, not recruiting
Vitoria, ES, Brazil, 29043-910
Active, not recruiting
Juiz de Fora, MG, Brazil, 36010-570
Not yet recruiting
Rio de Janeiro, RJ, Brazil, 20551-030
Not yet recruiting
Porto Alegre, RS, Brazil, 90610-000
Active, not recruiting
Campinas, SP, Brazil, 13077-005
Completed
Sao Jose do Rio Preto, SP, Brazil, 15090-000
Recruiting
Sao Paulo, SP, Brazil, 04039-004
Active, not recruiting
Sao Paulo, SP, Brazil, 04026-000
Active, not recruiting
Sao Paulo, SP, Brazil, 04027-000
Active, not recruiting
Sao Paulo, SP, Brazil, 04266-010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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: March 3, 2014
Health Authority: Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)

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

ClinicalTrials.gov processed this record on November 25, 2014