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A Long-Term Extension Study to WA19926 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.
ClinicalTrials.gov Identifier: NCT01665430
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: tocilizumab [RoActemra/Actemra] Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
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 From Poland With Early, Moderate to Severe Rheumatoid Arthritis.
Study Start Date : August 2012
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]
  2. Rates of adverse events leading to dose modification or study withdrawal [ Time Frame: approximately 3 years ]
  3. Incidence of clinically significant laboratory abnormalities [ Time Frame: approximately 3 years ]

Secondary Outcome Measures :
  1. Change in Disease Activity Score 28 Erythrocyte sedimentation rate (DAS28-ESR) [ Time Frame: from baseline to Week 104 ]
  2. Change in tender/swollen joint counts (TJC/SJC) [ Time Frame: from baseline to Week 104 ]
  3. 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 ]
  4. Time to rheumatoid arthritis flare in patients who have entered drug-free remission [ Time Frame: approximately 3 years ]

Eligibility Criteria

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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01665430


Locations
Poland
Bytom, Poland, 41-902
Elblag, Poland, 82-300
Poznan, Poland, 60-218
Warszawa, Poland, 02-637
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01665430     History of Changes
Other Study ID Numbers: ML28175
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016

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