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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
Results First Received: May 23, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Intervention: Drug: Tocilizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Subcutaneous (SC) Tocilizumab (TCZ) Every 2 Weeks (Q2W) Participants with moderate to severe rheumatoid arthritis (RA) who completed treatment with SC or intravenous (IV) TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this long-term extension (LTE) study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 milligrams (mg) Q2W.
SC TCZ Every Week (QW) Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
Not Treated Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) were enrolled in this LTE study for an additional 96 weeks. Participants who met Screening criteria but did not receive treatment were excluded from analysis and reported in a separate arm.

Participant Flow:   Overall Study
    Subcutaneous (SC) Tocilizumab (TCZ) Every 2 Weeks (Q2W)   SC TCZ Every Week (QW)   Not Treated
STARTED   44   173   1 
COMPLETED   39   144   0 
NOT COMPLETED   5   29   1 
Adverse Event or Intercurrent Illness                1                12                0 
Lack of Efficacy                1                6                0 
Lost to Follow-up                0                4                0 
Protocol Violation                1                0                0 
Withdrawal by Subject                2                4                1 
Physician Decision                0                2                0 
Not Specified                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: All participants who received at least one dose of study medication and had at least one post-dose safety assessment.

Reporting Groups
  Description
SC TCZ Q2W Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
SC TCZ QW Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
Total Total of all reporting groups

Baseline Measures
   SC TCZ Q2W   SC TCZ QW   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   173   217 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.7  (10.18)   58.1  (10.38)   58.4  (10.33) 
Gender 
[Units: Participants]
     
Female   33   133   166 
Male   11   40   51 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Primary:   Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline   [ Time Frame: Baseline ]

5.  Primary:   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) ]

6.  Secondary:   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) ]

7.  Secondary:   Disease Activity Score Based on 28 Joints (DAS28) Score   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]

8.  Secondary:   Change From Baseline in DAS28 Score   [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ]

9.  Secondary:   Clinical Disease Activity Index (CDAI) Score   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]

10.  Secondary:   Change From Baseline in CDAI Score   [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ]

11.  Secondary:   Simplified Disease Activity Index (SDAI) Score   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]

12.  Secondary:   Change From Baseline in SDAI Score   [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ]

13.  Secondary:   Tender Joint Count (TJC) Score   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]

14.  Secondary:   Change From Baseline in TJC Score   [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ]

15.  Secondary:   Swollen Joint Count (SJC) Score   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]

16.  Secondary:   Change From Baseline in SJC Score   [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ]

17.  Secondary:   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) ]

18.  Secondary:   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) ]

19.  Secondary:   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) ]

20.  Secondary:   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) ]

21.  Secondary:   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) ]

22.  Secondary:   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) ]

23.  Secondary:   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) ]

24.  Secondary:   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) ]

25.  Secondary:   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) ]

26.  Secondary:   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) ]

27.  Secondary:   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) ]

28.  Secondary:   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) ]

29.  Secondary:   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) ]

30.  Secondary:   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 ]

31.  Secondary:   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 ]

32.  Secondary:   Global Assessment of Pain by the Participant According to VAS Score   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]

33.  Secondary:   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 ]

34.  Secondary:   Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]

35.  Secondary:   Change From Baseline in HAQ-DI Score   [ Time Frame: Baseline to Weeks 12, 24, 36, 48, 60, 72, 84 ]

36.  Secondary:   Percentage of Participants With HAQ-DI Score <0.5   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]

37.  Secondary:   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 ]

38.  Secondary:   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 ]

39.  Secondary:   Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]

40.  Secondary:   Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria   [ Time Frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



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