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

Last updated: March 9, 2023
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Arthritis And Arthritic Pain

Joint Injuries

Rheumatoid Arthritis

Treatment

Tocilizumab

Clinical Study ID

NCT01664598
ML28124
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Participants who complete their last WA19926 core study visit (Week 104) and who maybenefit from study drug treatment according to the Investigator's assessment
  • No current or recent adverse event or laboratory finding preventing the use of thestudy drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
  • Women of childbearing potential must agree to use adequate contraception as defined byprotocol during the treatment period

Exclusion

Exclusion Criteria:

  • Pregnant females
  • Participants who have withdrawn prematurely from the WA19926 core study for any reason
  • Treatment with any investigational agent or cell-depleting therapies since the lastadministration 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 inWA19926
  • Immunization with a live/attenuated vaccine since the last administration of studydrug in WA19926
  • Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease otherthan rheumatoid arthritis
  • Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other thanrheumatoid arthritis
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonalantibodies, 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

Study Design

Total Participants: 49
Treatment Group(s): 1
Primary Treatment: Tocilizumab
Phase: 3
Study Start date:
May 01, 2012
Estimated Completion Date:
June 30, 2015

Connect with a study center

  • Ekaterinburg, 620102
    Russian Federation

    Site Not Available

  • Moscow, 129327
    Russian Federation

    Site Not Available

  • Ryazan, 390011
    Russian Federation

    Site Not Available

  • Saint-Petersburg, 195067
    Russian Federation

    Site Not Available

  • Saratov, 410002
    Russian Federation

    Site Not Available

  • empty

    St Petersburg, 191015
    Russian Federation

    Site Not Available

  • Tula, 300053
    Russian Federation

    Site Not Available

  • Voronezh, 394066
    Russian Federation

    Site Not Available

  • Yaroslavl, 150030
    Russian Federation

    Site Not Available

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