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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01664598
Recruitment Status : Completed
First Posted : August 14, 2012
Last Update Posted : August 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, single arm, multicenter long-term extension study of WA19926 will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: tocilizumab [RoActemra/Actemra] Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: RoActemra/Actemra Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 104 weeks

Primary Outcome Measures :
  1. Long-term safety: Incidence of adverse events [ Time Frame: approximately 3 years ]

Secondary Outcome Measures :
  1. Efficacy according to DAS28-ESR/SDAI/TJC/SJC [ Time Frame: approximately 3 years ]
  2. Sustained drug-free remission according to DAS28-ESR/SDAI remission criteria [ Time Frame: approximately 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01664598

Russian Federation
Ekaterinburg, Russian Federation, 620102
Moscow, Russian Federation, 105203
Moscow, Russian Federation, 115522
Moscow, Russian Federation, 115682
Moscow, Russian Federation, 119049
Moscow, Russian Federation, 129327
Ryazan, Russian Federation, 390011
Saint-Petersburg, Russian Federation, 195067
Saratov, Russian Federation, 410002
Tula, Russian Federation, 300053
Voronezh, Russian Federation, 394066
Yaroslavl, Russian Federation, 150030
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01664598     History of Changes
Other Study ID Numbers: ML28124
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases