A Long-Term Safety Extension Study of WA19926 in Patients With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01649804
First received: July 23, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This extension study of WA19926 will assess the long-term safety and the efficac y of RoActemra/Actemra (tocilizumab) treatment in patients with rheumatoid arthr itis. Patients who have completed the core study WA19926 are eligible to partici pate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 week s. 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:


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 ]

Enrollment: 12
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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
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: NCT01649804

Locations
Hungary
Budapest, Hungary, 1027
Debrecen, Hungary, 4032
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: August 4, 2014
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 September 22, 2014