A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)

NCT01662063 | Completed Phase 3 Results

• 1 other identifier: ML28338
• Study Type: interventional
• Target: 218
• Locations: 2 countries
• Sites: 79

Brief Summary

This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96 weeks.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (5)

• Number of Participants With at Least One Serious Adverse Event (SAE)

  Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.

  From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)

• Percentage of Participants With at Least One SAE

  AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.

  From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)

• Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint

  Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.

  From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)

• Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline

  Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.

  Baseline

• Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline

  Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.

  From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)

Secondary Outcomes (35)

• Percentage of Participants Who Correctly Administered All SC TCZ Doses

  From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)

• Disease Activity Score Based on 28 Joints (DAS28) Score

  Baseline and Weeks 12, 24, 36, 48, 60, 72, 84

• Change From Baseline in DAS28 Score

  Baseline to Weeks 12, 24, 36, 48, 60, 72, 84

• Clinical Disease Activity Index (CDAI) Score

  Baseline and Weeks 12, 24, 36, 48, 60, 72, 84

• Change From Baseline in CDAI Score

  Baseline to Weeks 12, 24, 36, 48, 60, 72, 84

Study Arms (2)

SC TCZ QW

EXPERIMENTAL

Participants who received IV TCZ in the previous trial will be switched to SC TCZ 162 mg QW, and those who received SC TCZ will continue at their same dosage of SC TCZ 162 mg QW. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.

Drug: Tocilizumab

SC TCZ Q2W

EXPERIMENTAL

Participants who received SC TCZ will continue at their same dosage of SC TCZ 162 mg Q2W. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.

Also known as: RoActemra/Actemra

SC TCZ Q2W; SC TCZ QW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core study on SC or IV TCZ and, based on the Investigator's judgment, may continue to benefit from TCZ 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

You may not qualify if:

• Premature withdrawal from WA22762 (NCT01194414) or NA25220 (NCT01232569) 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 at greater than (\>) 10 mg per day prednisone or equivalent, or non-steroidal anti-inflammatory drugs (NSAIDs) above the maximum recommended dose
• Intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline
• Treatment with any investigational or commercially available biologic disease-modifying anti-rheumatic drug (DMARD) other than TCZ at any time between completion of the core study WA22762 (NCT01194414) or NA25220 (NCT01232569) and enrollment in the long-term extension study
• Pregnant or breastfeeding women
• History of alcohol, drug, or chemical abuse within 1 year prior to Screening

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (79)

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Tuscaloosa, Alabama, 35406, United States

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Peoria, Arizona, 85381, United States

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Scottsdale, Arizona, 85258, United States

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Tucson, Arizona, 85704, United States

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Tucson, Arizona, 85715, United States

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Tucson, Arizona, 85723, United States

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Tucson, Arizona, 85724, United States

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Fullerton, California, 92835, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90048, United States

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San Diego, California, 92108, United States

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San Leandro, California, 94578, United States

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Upland, California, 91786, United States

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Van Nuys, California, 91405, United States

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West Hills, California, 91307, United States

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Whittier, California, 90606, United States

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Denver, Colorado, 80230-7127, United States

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Bridgeport, Connecticut, 06606, United States

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Trumbull, Connecticut, 06611, United States

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Jupiter, Florida, 33458, United States

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Orlando, Florida, 32806, United States

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Palm Harbor, Florida, 34684, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33614, United States

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Venice, Florida, 34233, United States

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Gainesville, Georgia, 30501, United States

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Coeur d'Alene, Idaho, 83814, United States

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Idaho Falls, Idaho, 83404, United States

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Meridian, Idaho, 83642, United States

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Morton Grove, Illinois, 60053, United States

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Springfield, Illinois, 62703, United States

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Vernon Hills, Illinois, 60061, United States

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Wichita, Kansas, 67208, United States

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Monroe, Louisiana, 71203, United States

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Hagerstown, Maryland, 21740, United States

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Wheaton, Maryland, 20902, United States

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Worcester, Massachusetts, 01605, United States

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Saint Claire Shores, Michigan, 48081, United States

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Eagan, Minnesota, 55121, United States

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Flowood, Mississippi, 39232, United States

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Jackson, Mississippi, 39202, United States

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Florissant, Missouri, 63031, United States

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St Louis, Missouri, 63117, United States

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St Louis, Missouri, 63141, United States

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Lincoln, Nebraska, 68516, United States

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Lebanon, New Hampshire, 03756, United States

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Clifton, New Jersey, 07012, United States

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Freehold, New Jersey, 07728, United States

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Manalapan, New Jersey, 07726, United States

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Voorhees Township, New Jersey, 08043, United States

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Albuquerque, New Mexico, 87102, United States

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Albany, New York, 12206, United States

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Brooklyn, New York, 11201, United States

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Orchard Park, New York, 14127, United States

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Asheville, North Carolina, 28803, United States

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Charlotte, North Carolina, 28210, United States

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Raleigh, North Carolina, 27615, United States

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Wilmington, North Carolina, 28401, United States

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Cincinnati, Ohio, 45219, United States

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Perrysburg, Ohio, 43551, United States

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Toledo, Ohio, 43606, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73104, United States

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Tulsa, Oklahoma, 74135, United States

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Bethlehem, Pennsylvania, 18015, United States

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Duncansville, Pennsylvania, 16635, United States

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Wyomissing, Pennsylvania, 19610, United States

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Charleston, South Carolina, 29407, United States

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Knoxville, Tennessee, 37909, United States

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Memphis, Tennessee, 38104, United States

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Memphis, Tennessee, 38119, United States

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Houston, Texas, 77004, United States

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Houston, Texas, 77074, United States

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Nassau Bay, Texas, 77058, United States

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Olympia, Washington, 98502, United States

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Seattle, Washington, 98104, United States

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Spokane, Washington, 99204, United States

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Wenatchee, Washington, 98801, United States

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Ponce, 00716, Puerto Rico

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Related Publications (1)

• Kivitz A, Wallace T, Olech E, Borofsky M, Devenport J, Pei J, Michalska M. Long-Term Safety and Efficacy of Subcutaneously Administered Tocilizumab for Adult Rheumatoid Arthritis: A Multicenter Phase 3b Long-term Extension Study. Rheumatol Ther. 2016 Dec;3(2):291-304. doi: 10.1007/s40744-016-0043-1. Epub 2016 Sep 24.

  PMID: 27747585 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 10, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 12, 2016
• Results First Posted: October 12, 2016

Record last verified: 2016-08

Locations

PR (1); US (78)