An Extension Study of WA19926 of the Long-Term Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis
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:
NCT01664598
First received: August 10, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This open-label, single arm, multicenter long-term extension study of WA19926 will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open-label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis |
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 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy according to DAS28-ESR/SDAI/TJC/SJC [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Sustained drug-free remission according to DAS28-ESR/SDAI remission criteria [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 71 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: RoActemra/Actemra |
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 104 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
- No current or recent adverse event or laboratory finding preventing the use of the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
- Women of childbearing potential must agree to use adequate contraception as defined by protocol during the treatment period
Exclusion Criteria:
- Pregnant females
- Patients who have withdrawn prematurely from the WA19926 core study for any reason
- Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
- Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926
- Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
- Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
- Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
- Evidence of severe uncontrolled concomitant disease or disorder
- Known active or history of recurrent infections
- Active tuberculosis requiring treatment in the previous 3 years
- History of alcohol, drug or chemical abuse since inclusion in the WA19926 study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664598
Contacts
| Contact: Please reference Study ID Number: ML28124 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Russian Federation | |
| Active, not recruiting | |
| Ekaterinburg, Russian Federation, 620102 | |
| Active, not recruiting | |
| Moscow, Russian Federation, 115522 | |
| Active, not recruiting | |
| Moscow, Russian Federation, 117049 | |
| Recruiting | |
| Moscow, Russian Federation, 129327 | |
| Active, not recruiting | |
| Moscow, Russian Federation, 115682 | |
| Active, not recruiting | |
| Moscow, Russian Federation, 105203 | |
| Active, not recruiting | |
| Ryazan, Russian Federation, 390026 | |
| Recruiting | |
| Saratov, Russian Federation, 410002 | |
| Active, not recruiting | |
| St Petersburg, Russian Federation, 191015 | |
| Active, not recruiting | |
| Tula, Russian Federation, 300053 | |
| Recruiting | |
| Voronezh, Russian Federation, 394066 | |
| Active, not recruiting | |
| Yaroslavl, Russian Federation, 150030 | |
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: | NCT01664598 History of Changes |
| Other Study ID Numbers: | ML28124 |
| Study First Received: | August 10, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Russia: Ministry of Healthcare and Social Development of the Russian Federation |
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