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A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664104
First received: August 7, 2012
Last updated: April 14, 2017
Last verified: April 2017
Results First Received: January 26, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 151 participants were enrolled in the study; of which,136 participants met the eligibility criteria. The results are reported only for those participants who met the eligibility criteria.

Reporting Groups
  Description
Rheumatoid Arthritis (RA) Participants Participants with moderate or severe RA who were under tocilizumab (TCZ) treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.

Participant Flow:   Overall Study
    Rheumatoid Arthritis (RA) Participants
STARTED   136 
COMPLETED   120 
NOT COMPLETED   16 
Adverse Event                6 
Lack of Efficacy                2 
Withdrawal by Subject                1 
Lost to Follow-up                4 
Other                1 
Unknown: Reason Unrelated to TCZ                2 



  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.
All enrolled participants evaluable for primary objective: All enrolled participants except participants who withdrew from study for reasons not related to TCZ and had not interrupted TCZ treatment at withdrawal; lost to follow-up participants in treatment with TCZ at withdrawal; or premature termination occurring until 5 months from start of TCZ.

Reporting Groups
  Description
RA Participants Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.

Baseline Measures
   RA Participants 
Overall Participants Analyzed 
[Units: Participants]
 133 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      114  85.7% 
Male      19  14.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants on TCZ Treatment at Month 6   [ Time Frame: Month 6 ]

2.  Secondary:   Percentage of Participants by TCZ Dose at Month 6   [ Time Frame: Month 6 ]

3.  Secondary:   Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)   [ Time Frame: Baseline ]

4.  Secondary:   Time Elapsed From Diagnosis of RA   [ Time Frame: Baseline (assessed retrospectively) ]

5.  Secondary:   Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline   [ Time Frame: Baseline ]

6.  Secondary:   Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline   [ Time Frame: Baseline ]

7.  Secondary:   Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline   [ Time Frame: Baseline ]

8.  Secondary:   Participant Assessment of Morning Stiffness Using VAS at Baseline   [ Time Frame: Baseline ]

9.  Secondary:   Participant Assessment of Fatigue Using VAS at Baseline   [ Time Frame: Baseline ]

10.  Secondary:   Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline   [ Time Frame: Baseline ]

11.  Secondary:   Tender Joint Count (TJC) at Baseline   [ Time Frame: Baseline ]

12.  Secondary:   Swollen Joint Count (SJC) at Baseline   [ Time Frame: Baseline ]

13.  Secondary:   Erythrocyte Sedimentation Rate (ESR) at Baseline   [ Time Frame: Baseline ]

14.  Secondary:   C-Reactive Protein (CRP) at Baseline   [ Time Frame: Baseline ]

15.  Secondary:   Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline   [ Time Frame: Baseline ]

16.  Secondary:   Percentage of Participants With Evidence of Structural Joint Damage at Baseline   [ Time Frame: Baseline ]

17.  Secondary:   Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline   [ Time Frame: Baseline ]

18.  Secondary:   Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline   [ Time Frame: Baseline ]

19.  Secondary:   Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline   [ Time Frame: Baseline ]

20.  Secondary:   Percentage of Participants by Duration of Morning Stiffness at Baseline   [ Time Frame: Baseline ]

21.  Secondary:   Number of Participants With TCZ Dose Change According to the Reason for Change   [ Time Frame: Baseline up to Month 6 ]

22.  Secondary:   Percentage of Participants by Number of TCZ Dose Modifications Per Participant   [ Time Frame: Baseline up to Month 6 ]

23.  Secondary:   Time in Days Elapsed Between TCZ Infusions   [ Time Frame: Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8 ]

24.  Secondary:   Percentage of Participants With TCZ Infusion Interruption   [ Time Frame: Baseline up to Month 6 ]

25.  Secondary:   Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation   [ Time Frame: Baseline up to Month 6 ]

26.  Secondary:   Percentage of Participants With TCZ Reintroduction   [ Time Frame: Baseline up to Month 6 ]

27.  Secondary:   Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline   [ Time Frame: Baseline ]

28.  Secondary:   Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, and Month 6 ]

29.  Secondary:   Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, and Month 6 ]

30.  Secondary:   Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, and Month 6 ]

31.  Secondary:   Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6   [ Time Frame: Baseline, Month 3, and Month 6 ]

32.  Secondary:   Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6   [ Time Frame: Baseline, Month 3, and Month 6 ]

33.  Secondary:   Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6   [ Time Frame: Baseline, Month 3, and Month 6 ]

34.  Secondary:   Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment   [ Time Frame: Month 3 and Month 6 ]

35.  Secondary:   Change From Baseline to Month 6 in TJC   [ Time Frame: Baseline and Month 6 ]

36.  Secondary:   Change From Baseline to Month 6 in SJC   [ Time Frame: Baseline and Month 6 ]

37.  Secondary:   Change From Baseline to Month 6 in PGH   [ Time Frame: Baseline and Month 6 ]

38.  Secondary:   Change From Baseline to Month 6 in PhGH   [ Time Frame: Baseline and Month 6 ]

39.  Secondary:   Change From Baseline to Month 6 in Patient's Assessment of Pain   [ Time Frame: Baseline and Month 6 ]

40.  Secondary:   Change From Baseline to Month 6 in HAQ-DI Score   [ Time Frame: Baseline and Month 6 ]

41.  Secondary:   Change From Baseline to Month 6 in Participant Assessment of Fatigue   [ Time Frame: Baseline and Month 6 ]

42.  Secondary:   Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness   [ Time Frame: Baseline and Month 6 ]

43.  Secondary:   Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI   [ Time Frame: Month 3 and Month 6 ]

44.  Secondary:   Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6   [ Time Frame: Month 3 and Month 6 ]

45.  Secondary:   Time to DMARD Dose Reduction   [ Time Frame: Baseline up to Month 6 ]

46.  Secondary:   Time to DMARD Dose Withdrawal   [ Time Frame: Baseline up to Month 6 ]

47.  Secondary:   Percentage of Participants by Reason for DMARD Withdrawal During the Study   [ Time Frame: Baseline up to Month 6 ]

48.  Secondary:   Time to Steroid Dose Reduction   [ Time Frame: Baseline up to Month 6 ]

49.  Secondary:   Time to Steroid Dose Withdrawal   [ Time Frame: Baseline up to Month 6 ]

50.  Secondary:   Change From Baseline in CRP at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, and Month 6 ]

51.  Secondary:   Change From Baseline in ESR at Month 3 and Month 6   [ Time Frame: Baseline, Month 3, and Month 6 ]

52.  Secondary:   CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6   [ Time Frame: Baseline ]

53.  Secondary:   Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6   [ Time Frame: Baseline ]

54.  Secondary:   Percentage of Participants With and Without Morning Stiffness   [ Time Frame: Month 3 and Month 6 ]

55.  Secondary:   Percentage of Participants by Duration of Morning Stiffness   [ Time Frame: Month 3 and Month 6 ]

56.  Secondary:   CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6   [ Time Frame: Baseline ]

57.  Secondary:   BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6   [ Time Frame: Baseline ]

58.  Secondary:   Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6   [ Time Frame: Baseline and Month 6 ]

59.  Secondary:   Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6   [ Time Frame: Baseline and Month 6 ]

60.  Secondary:   Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6   [ Time Frame: Baseline and Month 6 ]

61.  Secondary:   Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6   [ Time Frame: Baseline and Month 6 ]

62.  Secondary:   Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6   [ Time Frame: Baseline and Month 6 ]

63.  Secondary:   Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6   [ Time Frame: Baseline and Month 6 ]

64.  Secondary:   Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6   [ Time Frame: Baseline and Month 6 ]


  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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01664104     History of Changes
Other Study ID Numbers: ML28336
Study First Received: August 7, 2012
Results First Received: January 26, 2017
Last Updated: April 14, 2017