Text Size

A Long-Term Safety Extension Study of WA19926 in Patients With 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:
NCT01649804
First received: July 23, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in patients with rheumatoid arthritis. Patients who have completed the core study WA19926 are eligible to participate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety 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 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:
  • Long-term safety: incidence of adverse events [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Disease Activity Index 28 Erythrocyte sedimentation rate (DAS28-ESR) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Change in Simplified Disease Activity Index (SDAI) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Change in total tender joint count [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Change in total swollen joint count [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with clinical remission [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: July 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RoActemra/Actemra single arm Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks for 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 who have completed the core study WA19926 and according to the investigator may benefit from RoActemra/Actemra treatment
  • No current or recent adverse event or laboratory finding preventing the use of the study drug dose at baseline
  • Receiving treatment on an outpatient basis

Exclusion Criteria:

  • Females who are pregnant
  • Patients who have prematurely withdrawn from the core study WA19926 for any reason
  • Treatment with any investigational drug since the last administration of the study drug in the core study WA19926
  • Treatment with an anti-tumor necrosis (TNF), anti-interleukin 1 agent or T-cell costimulation modulator since the last administration of the study drug in the core study WA19926
  • Immunization with live/attenuated vaccine since the last administration of the study drug in the core study WA19926
  • Diagnosis since the last WA19926 visit of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
  • Abnormal laboratory values
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649804

Contacts
Contact: Please reference Study ID Number: ML28146 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Hungary
Recruiting
Budapest, Hungary, 1027
Recruiting
Debrecen, Hungary, 4032
Recruiting
Eger, Hungary, 3300
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: NCT01649804     History of Changes
Other Study ID Numbers: ML28146, 2011-006125-14
Study First Received: July 23, 2012
Last Updated: May 7, 2013
Health Authority: Hungary: National Institute of Pharmacy

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 21, 2013