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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01662063
First received: July 30, 2012
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Tocilizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label, Long-Term Extension Study of WA22762 and NA25220 to Evaluate 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:
  • Number of Participants With at Least One Serious Adverse Event (SAE) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With at Least One SAE [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Who Correctly Administered All SC TCZ Doses [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (>) 8 hours, and absence of other medication errors.

  • Disease Activity Score Based on 28 Joints (DAS28) Score [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.

  • Change From Baseline in DAS28 Score [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.

  • Clinical Disease Activity Index (CDAI) Score [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.

  • Change From Baseline in CDAI Score [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.

  • Simplified Disease Activity Index (SDAI) Score [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.

  • Change From Baseline in SDAI Score [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.

  • Tender Joint Count (TJC) Score [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.

  • Change From Baseline in TJC Score [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.

  • Swollen Joint Count (SJC) Score [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.

  • Change From Baseline in SJC Score [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.

  • Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.

  • Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.

  • Percentage of Reasons Given for DMARD Dose Reduction or Interruption [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.

  • Percentage of Reasons Given for DMARD Discontinuation [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.

  • Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.

  • Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.

  • Percentage of Reasons Given for CCS Dose Reduction [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.

  • Percentage of Reasons Given for CCS Dose Interruption [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.

  • Percentage of Reasons Given for CCS Discontinuation [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation >14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.

  • Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.

  • Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.

  • Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.

  • Time to Return to the QW Regimen After Switching to the Q2W Regimen [ Time Frame: From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall) ] [ Designated as safety issue: No ]
    Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.

  • Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no disease activity") to 100 mm ("maximum disease activity"), with higher scores representing an increase in perceived symptoms.

  • Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no disease activity") to 100 mm ("maximum disease activity"), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity.

  • Global Assessment of Pain by the Participant According to VAS Score [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no pain") to 100 mm ("unbearable pain"), with higher scores representing an increase in pain.

  • Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm ("no pain") to 100 mm ("unbearable pain"), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain.

  • Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.

  • Change From Baseline in HAQ-DI Score [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.

  • Percentage of Participants With HAQ-DI Score <0.5 [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score <0.5 was calculated at each visit.

  • Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.

  • Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.

  • Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.

  • Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ] [ Designated as safety issue: No ]
    Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.


Enrollment: 218
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC TCZ QW
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
TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
Other Name: RoActemra/Actemra
Experimental: SC TCZ Q2W
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
TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
Other Name: RoActemra/Actemra

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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
Peoria, Arizona, United States, 85381
Scottsdale, Arizona, United States, 85258
Tucson, Arizona, United States, 85704
Tucson, Arizona, United States, 85715
Tucson, Arizona, United States, 85723
Tucson, Arizona, United States, 85724
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
Van Nuys, California, United States, 91405
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
Jupiter, Florida, United States, 33458
Orlando, Florida, United States, 32806
Palm Harbor, Florida, United States, 34684
South Miami, Florida, United States, 33143
Tampa, Florida, United States, 33614
Venice, Florida, United States, 34233
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, 62703
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
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
Freehold, New Jersey, United States, 07728
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
Perrysburg, Ohio, United States, 43551
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
Wyomissing, Pennsylvania, United States, 19610
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
Nassau Bay, Texas, United States, 77058
United States, Washington
Olympia, Washington, United States, 98502
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99204
Wenatchee, Washington, United States, 98801
Puerto Rico
Ponce, Puerto Rico, 00716
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01662063     History of Changes
Other Study ID Numbers: ML28338 
Study First Received: July 30, 2012
Results First Received: May 23, 2016
Last Updated: August 17, 2016
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 December 02, 2016