A Long-Term Safety Extension Study of WA19926 in Patients With 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: NCT01649804
• Other study ID #: ML28146
• Secondary ID: 2011-006125-14
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2012
• Last updated: March 1, 2016
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in patients with rheumatoid arthritis. Patients who have completed the core study WA19926 are eligible to participate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/=18 years of age who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment

• No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline

• Receiving treatment on an outpatient basis

Exclusion Criteria:

• Females who are pregnant

• Patients who have prematurely withdrawn from the core study WA19926 for any reason

• Treatment with any investigational drug since the last administration of the study drug in the core study WA19926

• Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926

• Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926

• Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis

• Abnormal laboratory values

Study Design

Endpoint Classification: Safety 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 intravenously every 4 weeks for 104 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety: incidence of adverse events		104 weeks	No
Secondary	Change in Disease Activity Index 28 Erythrocyte sedimentation rate (DAS28-ESR)		104 weeks	No
Secondary	Change in Simplified Disease Activity Index (SDAI)		104 weeks	No
Secondary	Change in total tender joint count		104 weeks	No
Secondary	Change in total swollen joint count		104 weeks	No
Secondary	Proportion of patients with clinical remission		104 weeks	No