A Long-term Safety Extension Study in Patients With Rheumatoid Arthritis Having Completed the Studies ML21530 And MA21488
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01715831
First received: October 25, 2012
Last updated: May 7, 2013
Last verified: May 2013
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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:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Tocilizumab
U.S. FDA Resources
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: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715831
Contacts
| Contact: Please reference Study ID Number: ML28091 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Brazil | |
| Not yet recruiting | |
| Belo Horizonte, Brazil, 30130-100 | |
| Not yet recruiting | |
| Botucatu, Brazil, 18618-970 | |
| Not yet recruiting | |
| Campinas, Brazil, 13083-970 | |
| Active, not recruiting | |
| Juiz de Fora, Brazil, 36010-570 | |
| Not yet recruiting | |
| Porto Alegre, Brazil, 90610-000 | |
| Not yet recruiting | |
| Rio de Janeiro, Brazil, 20551030 | |
| Recruiting | |
| Sao Jose Do Rio Preto, Brazil, 15090-000 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 04039-004 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 05651-901 | |
| Recruiting | |
| Sao Paulo, Brazil, 04037-003 | |
| Active, not recruiting | |
| Sao Paulo, Brazil, 04209-003 | |
| Recruiting | |
| Vitoria, Brazil, 29040-091 | |
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: | May 7, 2013 |
| 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 |
ClinicalTrials.gov processed this record on May 22, 2013