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A Long-Term Extension Study of WA22762 and NA25220 of RoActemra/Actemra (Tocilizumab) Administered Subcutaneously in Patients With Moderate to Severe Rheumatoid Arthritis

This study is currently recruiting participants.
Verified December 2012 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01662063
First received: July 30, 2012
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

This open-label extension study will evaluate the long-term safety and efficacy of subcutaneous (SC) RoActemra/Actemra in patients with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or 96-week NA25220 core studies on subcutaneous or intravenous (IV) RoActemra/Actemra. Patients will receive RoActemra/Actemra 162 mg subcutaneously every week or every 2 weeks (qw or q2w). Anticipated time on study treatment is 96 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 Long Term Extension Study of WA22762 and NA25220 to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With 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 Genentech:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of immunogenicity [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Long-term efficacy: Change in disease activity (DAS28-ESR/CDAI/SDAI/TJC/SJC) [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
  • Non-biologic DMARD/corticosteroid reductions/discontinuation [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Number of patients experiencing subcutaneous tocilizumab interval spacing (every week to every 2 weeks) for safety versus efficacy [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Percentage of patients experiencing subcutaneous tocilizumab interval spacing (every week to every 2 weeks) for safety versus efficacy [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Time to and reason for restoration of weekly SC dosing regimen [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Patient compliance [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RoActemra SC Drug: tocilizumab [RoActemra/Actemra]
162 mg SC qw or q2w

  Eligibility

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

Inclusion Criteria:

  • Completed the 97-week WA22762 or 96-week NA25220 core study on SC or IV RoActemra/Actemra and, based on the investigator's judgment, may continue to benefit from RoActemra/Actemra treatment in this study investigating the SC formulation
  • Receiving treatment on an outpatient basis
  • Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol

Exclusion Criteria:

  • Patients who have prematurely withdrawn form WA22762 or NA25220 core studies for any reason
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • Evidence of serious uncontrolled concomitant disease or disorder
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
  • Any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
  • History of or currently active primary or secondary immunodeficiency
  • Oral corticosteroids > 10 mg/day prednisolone or equivalent or NSAIDs > maximum recommended dose
  • Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline
  • Treatment with any investigational or commercially available biologic DMARD other than RoActemra/Actemra at any time between completion of the core study (WA22762 or NA25220) and enrollment in the LTE study
  • Pregnant or breastfeeding women
  • History of alcohol, drug or chemical abuse within 1 year prior to screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662063

Contacts
Contact: Please reference Study ID Number: ML28338 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 48 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01662063     History of Changes
Other Study ID Numbers: ML28338
Study First Received: July 30, 2012
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

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