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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 August 2016
• Main ID: NCT01664598
• Date of registration: 10/08/2012
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: An Extension Study of WA19926 of the Long-Term Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: May 2012
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01664598
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Russian Federation

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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 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 the treatment period

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- Patients who have withdrawn prematurely from the WA19926 core study for any reason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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: tocilizumab [RoActemra/Actemra]

Primary Outcome(s)

Long-term safety: Incidence of adverse events [Time Frame: approximately 3 years]

Secondary Outcome(s)

Efficacy according to DAS28-ESR/SDAI/TJC/SJC [Time Frame: approximately 3 years]

Sustained drug-free remission according to DAS28-ESR/SDAI remission criteria [Time Frame: approximately 3 years]

Secondary ID(s)

ML28124

Source(s) of Monetary Support

Please refer to primary and secondary sponsors