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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01662063
First received: July 30, 2012
Last updated: July 7, 2014
Last verified: July 2014

July 30, 2012
July 7, 2014
August 2012
June 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01662063 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Long-Term Extension Study of WA22762 and NA25220 of RoActemra/Actemra (Tocilizumab) Administered Subcutaneously in Patients With Moderate to Severe Rheumatoid Arthritis
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

This open-label extension study will evaluate the long-term safety and efficacy of subcutaneous (SC) RoActemra/Actemra in patients with moderate to severe rheum atoid arthritis who have completed the 97-week WA22762 or 96-week NA25220 core s tudies on subcutaneous or intravenous (IV) RoActemra/Actemra. Patients will rece ive RoActemra/Actemra 162 mg subcutaneously every week or every 2 weeks (qw or q2w). Anticipated time on study treatment is 96 weeks.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
162 mg SC qw or q2w
Experimental: RoActemra SC
Intervention: Drug: tocilizumab [RoActemra/Actemra]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01662063
ML28338
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP