A Long-Term Extension Study of WA22763 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 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: NCT01734993
• Other study ID #: ML28544
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2012
• Last updated: August 1, 2016
• Start date: November 2012
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
• 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 in patients with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 core study. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly for 104 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2015
• Est. primary completion date: September 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 core study on subcutaneous or intravenous RoActemra/Actemra and who experienced at any time during WA22762 clinically significant improvement in DAS28 (>1.2 points), and based on the investigator's judgment may continue to benefit from RoActemra/Actemra treatment in this study investigating the subcutaneous formulation

• No current or recent adverse events or laboratory findings preventing the use of the study drug dose of RoActemra/Actemra 162 mg sc at baseline visit

• 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 during the study and for at least 3 months following the last dose of study drug

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

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

Exclusion Criteria:

• Patients who have prematurely withdrawn from the WA22762 core study for any reason

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

• 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 the WA22762 core study

• Immunization with a live/attenuated vaccine since the last administration of study drug in the WA22762 core study

• Diagnosis since last WA22762 visit (Week 97) of rheumatic disease other than rheumatoid arthritis; secondary Sjörgen's syndrome with RA is permitted

• Diagnosis since last WA22762 visit (Week 97) of inflammatory joint disease other than rheumatoid arthritis

• Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids

• Evidence of serious uncontrolled concomitant disease

• Known active current or history of recurrent infection

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

• Body weight > 150 kg

• Pregnant or lactating women

• Inadequate hematologic, renal or liver function

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, 104 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 2.5 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 104	No
Secondary	Change in total tender joint count (TJC) / swollen joint count (SJC)		from baseline to Week 104	No
Secondary	Proportion of patients with remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 52 and 104		approximately 2.5 years	No
Secondary	Proportion of patients with corticosteroid dose reductions and/or discontinuation		approximately 2.5 years	No