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A Long Term Extension Study of WA19926 (NCT01649804) of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01668966
First received: August 16, 2012
Last updated: November 2, 2016
Last verified: November 2016
  Purpose
This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01649804) will evaluate the safety and efficacy of tocilizumab in participants with early moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 (NCT01649804) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Tocilizumab
Phase 3

Study Type: Interventional
Study Design: 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 With Early, Moderate to Severe Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to approximately 2.5 years ]
  • Percentage of Participants With AEs of Special Interest [ Time Frame: Baseline up to approximately 2.5 years ]
  • Percentage of Participants With AEs Leading to Change in Dose or Study Discontinuation [ Time Frame: Baseline up to approximately 2.5 years ]

Secondary Outcome Measures:
  • Change from Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Specified Time Points [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation), follow-up 2 (16 weeks after the last visit or discontinuation) up to approximately 2.5 years ]
  • Change from Baseline in Simplified Disease Activity Index (SDAI) Score at Specified Time Points [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation), follow-up 2 (16 weeks after the last visit or discontinuation) up to approximately 2.5 years ]
  • Change from Baseline in Swollen Joint Count (SJC) at Specified Time Points [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation), follow-up 2 (16 weeks after the last visit or discontinuation) up to approximately 2.5 years ]
  • Change from Baseline in Tender Joint Count (TJC) at Specified Time Points [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation), follow-up 2 (16 weeks after the last visit or discontinuation) up to approximately 2.5 years ]
  • Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment is Discontinued [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation), follow-up 2 (16 weeks after the last visit or discontinuation) up to approximately 2.5 years ]
  • Time to Rheumatoid Arthritis Relapse Among Participants Who Achieve Clinical Remission Without Drug [ Time Frame: Baseline up to approximately 2.5 years ]
  • Patient's Global Assessment of Disease Activity (PGA), Using Visual Analog Scale (VAS) Score [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation), follow-up 2 (16 weeks after the last visit or discontinuation) up to approximately 2.5 years ]
  • Participant Assessment of Pain, Using VAS Score [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation), follow-up 2 (16 weeks after the last visit or discontinuation) up to approximately 2.5 years ]
  • Health Assessment Questionnaire-Disease Index (HAQ-DI) Score [ Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation), follow-up 2 (16 weeks after the last visit or discontinuation) up to approximately 2.5 years ]

Enrollment: 24
Study Start Date: December 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tocilizumab
Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) every 4 weeks for up to 104 weeks.
Drug: Tocilizumab
Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
Other Name: RoActemra, Actemra

  Eligibility

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

Inclusion Criteria:

  • Participants who completed their last WA19926 (NCT01649804) 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 tocilizumab 8 mg/kg at baseline visit
  • Women of childbearing potential must agree to use highly reliable contraception during the treatment period

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason
  • Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 (NCT01649804)
  • 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 (NCT01649804)
  • Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 (NCT01649804)
  • Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
  • Diagnosis since last WA19926 (NCT01649804) 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 infections 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 (NCT01649804) study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668966

Locations
Brazil
Goiania, GO, Brazil, 74110-120
Juiz de Fora, MG, Brazil, 36036-330
Curtiba, PR, Brazil, 80030-110
Porto Alegre, RS, Brazil, 90610-000
Sao Paulo, SP, Brazil, 04026-000
Sao Paulo, SP, Brazil, 04266-010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01668966     History of Changes
Other Study ID Numbers: ML28080 
Study First Received: August 16, 2012
Last Updated: November 2, 2016

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

ClinicalTrials.gov processed this record on February 20, 2017