A Long-Term Extension Study of WA19926 on the Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655381
• Other study ID #: ML28174
• Secondary ID: 2011-005516-29
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2012
• Last updated: July 1, 2016
• Start date: April 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Securité du Médicament ANSM
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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• Patients who have withdrawn prematurely from the WA19926 core study for any reason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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety: Incidence of adverse events		approximately 3.5 years	No
Secondary	Efficacy according to DAS28-ESR/SDAI/TJC/SJC		approximately 3.5 years	No
Secondary	Sustained drug-free remission according to DAS28-ESR/SDAI criteria		approximately 3.5 years	No