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, Inc.
ClinicalTrials.gov Identifier:
NCT01662063
First received: July 30, 2012
Last updated: October 6, 2014
Last verified: October 2014
  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 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.


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:


Further study details as provided by Genentech, Inc.:

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 ]

Enrollment: 218
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: June 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
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: NCT01662063

  Hide Study Locations
Locations
United States, Alabama
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Phoenix, Arizona, United States, 85027
Scottsdale, Arizona, United States, 85258
Tucson, Arizona, United States, 85704
Tucson, Arizona, United States, 85724
Tucson, Arizona, United States, 85712
Tuscon, Arizona, United States, 85723
United States, California
Fullerton, California, United States, 92835
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90048
San Diego, California, United States, 92108
San Leandro, California, United States, 94578
Upland, California, United States, 91786
West Hills, California, United States, 91307
Whittier, California, United States, 90606
United States, Colorado
Denver, Colorado, United States, 80230-7127
United States, Connecticut
Bridgeport, Connecticut, United States, 06606
Trumbull, Connecticut, United States, 06611
United States, Florida
Boca Raton, Florida, United States, 33486
Jupiter, Florida, United States, 33458
Miami, Florida, United States, 33133
Ocala, Florida, United States, 34474
Orlando, Florida, United States, 32806
Palm Habor, Florida, United States, 34684
Palm Harbor, Florida, United States, 34684
Sarasota, Florida, United States, 34292
South Miami, Florida, United States, 33143
Tampa, Florida, United States, 33614
United States, Georgia
Gainesville, Georgia, United States, 30501
United States, Idaho
Coeur D'alene, Idaho, United States, 83814
Idaho Falls, Idaho, United States, 83404
Meridian, Idaho, United States, 83642
United States, Illinois
Morton Grove, Illinois, United States, 60053
Springfield, Illinois, United States, 62704
Vernon Hills, Illinois, United States, 60061
United States, Kansas
Wichita, Kansas, United States, 67208
United States, Louisiana
Monroe, Louisiana, United States, 71203
United States, Maryland
Crofton, Maryland, United States, 21114
Hagerstown, Maryland, United States, 21740
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Worcester, Massachusetts, United States, 01605
United States, Michigan
St. Claire Shores, Michigan, United States, 48081
United States, Minnesota
Eagan, Minnesota, United States, 55121
United States, Mississippi
Flowood, Mississippi, United States, 39232
Jackson, Mississippi, United States, 39202
United States, Missouri
Florissant, Missouri, United States, 63031
Saint Louis, Missouri, United States, 63117
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Lincoln, Nebraska, United States, 68516
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Clifton, New Jersey, United States, 07012
Manalapan, New Jersey, United States, 07726
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
United States, New York
Albany, New York, United States, 12206
Brooklyn, New York, United States, 11201
Orchard Park, New York, United States, 14127
United States, North Carolina
Asheville, North Carolina, United States, 28803
Charlotte, North Carolina, United States, 28210
Raleigh, North Carolina, United States, 27615
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati, Ohio, United States, 45219
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Oklahoma City, Oklahoma, United States, 73104
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Bethlehem, Pennsylvania, United States, 18015
Duncansville, Pennsylvania, United States, 16635
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Charleston, South Carolina, United States, 29407
United States, Tennessee
Knoxville, Tennessee, United States, 37909
Memphis, Tennessee, United States, 38104
Memphis, Tennessee, United States, 38119
United States, Texas
Houston, Texas, United States, 77004
Houston, Texas, United States, 77074
Houston, Texas, United States, 77034
San Antonio, Texas, United States, 78217
United States, Washington
Olympia, Washington, United States, 98502
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99204
Wenatchee, Washington, United States, 98801-0489
Puerto Rico
Ponce, Puerto Rico, 00716
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01662063     History of Changes
Other Study ID Numbers: ML28338
Study First Received: July 30, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014