A Long-Term Extension Study of WA19926 on the 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:
NCT01655381
First received: July 30, 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 3.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy according to DAS28-ESR/SDAI/TJC/SJC [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
- Sustained drug-free remission according to DAS28-ESR/SDAI criteria [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 21 |
| Study Start Date: | April 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
|
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, at baseline or later if they are in remission DAS28 at Week 104 of WA19926, 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 and up to 3 months after treatment
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: NCT01655381
Contacts
| Contact: Please reference Study ID Number: ML28174 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| France | |
| Recruiting | |
| Cahors, France, 46005 | |
| Active, not recruiting | |
| Montpellier, France, 34295 | |
| Active, not recruiting | |
| Mulhouse, France, 68070 | |
| Recruiting | |
| Orleans, France, 45032 | |
| Active, not recruiting | |
| Paris, France, 75651 | |
| Recruiting | |
| Toulouse, France, 31059 | |
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: | NCT01655381 History of Changes |
| Other Study ID Numbers: | ML28174, 2011-005516-29 |
| Study First Received: | July 30, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | France: Agence Nationale de Securité du Médicament ANSM |
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 16, 2013