A Long-Term Extension Study of WA22762 and NA25220 of RoActemra/Actemra (Tocilizumab) Administered Subcutaneously in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Multicenter, Open Label Long Term Extension Study of WA22762 and NA25220 to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662063
• Other study ID #: ML28338
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2012
• Last updated: April 2, 2016
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open-label extension study will evaluate the long-term safety and efficacy of subcutaneous (SC) RoActemra/Actemra in patients with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or 96-week NA25220 core studies on subcutaneous or intravenous (IV) RoActemra/Actemra. Patients will receive RoActemra/Actemra 162 mg subcutaneously every week or every 2 weeks (qw or q2w). Anticipated time on study treatment is 96 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completed the 97-week WA22762 or 96-week NA25220 core study on SC or IV RoActemra/Actemra and, based on the investigator's judgment, may continue to benefit from RoActemra/Actemra treatment in this study investigating the SC formulation

• Receiving treatment on an outpatient basis

• Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol

Exclusion Criteria:

• Patients who have prematurely withdrawn form WA22762 or NA25220 core studies for any reason

• History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies

• Evidence of serious uncontrolled concomitant disease or disorder

• Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections

• Any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening

• History of or currently active primary or secondary immunodeficiency

• Oral corticosteroids > 10 mg/day prednisolone or equivalent or NSAIDs > maximum recommended dose

• Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline

• Treatment with any investigational or commercially available biologic DMARD other than RoActemra/Actemra at any time between completion of the core study (WA22762 or NA25220) and enrollment in the LTE study

• Pregnant or breastfeeding women

• History of alcohol, drug or chemical abuse within 1 year prior to screening

Study Design

Allocation: Non-Randomized, 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]
162 mg SC qw or q2w

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 2 years	No
Primary	Safety: Incidence of immunogenicity		approximately 2 years	No
Secondary	Long-term efficacy: Change in disease activity (DAS28-ESR/CDAI/SDAI/TJC/SJC)		from baseline to Week 96	No
Secondary	Non-biologic DMARD/corticosteroid reductions/discontinuation		approximately 2 years	No
Secondary	Number of patients experiencing subcutaneous tocilizumab interval spacing (every week to every 2 weeks) for safety versus efficacy		approximately 2 years	No
Secondary	Percentage of patients experiencing subcutaneous tocilizumab interval spacing (every week to every 2 weeks) for safety versus efficacy		approximately 2 years	No
Secondary	Time to and reason for restoration of weekly SC dosing regimen		approximately 2 years	No
Secondary	Patient compliance		approximately 2 years	No