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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01665430
First received: August 13, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 From Poland With Early, Moderate to Severe Rheumatoid Arthritis.

Resource links provided by NLM:

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Rates of adverse events leading to dose modification or study withdrawal [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Incidence of clinically significant laboratory abnormalities [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Disease Activity Score 28 Erythrocyte sedimentation rate (DAS28-ESR) [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
  • Change in tender/swollen joint counts (TJC/SJC) [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving drug-free remission, defined as clinical remission (DAS28-ESR < 2.6) for two consecutive assessment visits followed by discontinuation of RoActemra/Actemra [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Time to rheumatoid arthritis flare in patients who have entered drug-free remission [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm: RoActemra/Actemra Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, up to 104 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients who complete WA19926 core study (visit at Week 104 and two follow-up telephone visits) 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
  • Receiving treatment on an outpatient basis
  • Females of child-bearing potential must agree to use at least one adequate method of contraception as defined by protocol during the treatment period

Exclusion Criteria:

  • Pregnant women
  • Patients who have prematurely withdrawn from the WA19926 study for any reason
  • Treatment with any investigational agent or cell depleting therapies since last administration of study drug in the WA 19926 core study
  • 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 the study drug in the WA19926 core study
  • Immunization with a live/attenuated vaccine since the last administration of study drug in the WA19926 core study
  • Diagnosis since visit at Week 104 of the core WA19926 study of rheumatic autoimmune disease other than rheumatoid arthritis
  • Diagnosis since visit at Week 104 of the core WA19926 study of inflammatory joint disease other than rheumatoid arthritis
  • Evidence of serious uncontrolled concomitant disease or disorder
  • Known active or history of recurrent infection
  • Current liver disease as determined by Investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665430

Contacts
Contact: Please reference Study ID Number: ML28175 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Poland
Recruiting
Bytom, Poland, 41902
Recruiting
Elblag, Poland, 82-300
Recruiting
Poznan, Poland, 60-218
Recruiting
Warszawa, Poland, 02-637
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01665430     History of Changes
Other Study ID Numbers: ML28175
Study First Received: August 13, 2012
Last Updated: May 7, 2013
Health Authority: Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013