A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) 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 SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772316
• Other study ID #: ML28488
• Secondary ID: 2012-002632-87
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2013
• Last updated: May 4, 2016
• Start date: December 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly (for patients entering from WA22762) or every two weeks (for patients entering from NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Patients who have completed the 97-week WA22762 or 96-week NA25220 core study on subcutaneous or intravenous RoActemra/Actemra and based on the investigator's judgment may continue to benefit from RoActemra/Actemra treatment in this study investigating the subcutaneous formulation

• Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the maximum recommended dose are permitted if on a stable dose regimen for >/= 4 weeks prior to baseline

• Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed

• 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

Exclusion Criteria:

• Patients who have prematurely withdrawn from the WA22762 or NA25220 core studies for any reason

• Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies

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

• Evidence of serious uncontrolled concomitant disease

• Current liver disease as determined by the principal investigator

• History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations

• Known active current or history of recurrent infections

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

• Active TB requiring treatment within the previous 3 years

• Primary or secondary immunodeficiency (history of or currently active)

• Pregnant or breast feeding women

• Body weight > 150 kg

• Inadequate renal, hepatic or hematologic function

• Positive for hepatitis B or hepatitis C

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]
162 mg subcutaneously weekly or every two weeks, 96 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety: Incidence of adverse events		approximately 2 years	No
Secondary	Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)		from baseline to Week 96	No
Secondary	Change in total tender joint count (TJC) / swollen joint count (SJC)		from baseline to Week 96	No
Secondary	Proportion of patients with remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96		approximately 2 years	No
Secondary	Proportion of patients with DMARD/corticosteroid dose reductions and/or discontinuation		approximately 2 years	No
Secondary	Long-term patient compliance		approximately 2 years	No