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A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01462162
First received: October 27, 2011
Last updated: September 8, 2016
Last verified: September 2016
Results First Received: December 1, 2015  
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
Total of 122 participants were recruited, 2 participants were excluded from analysis, one due to non-compliance with the inclusion criteria and other due to compliance with the exclusion criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rheumatoid Arthritis Participants Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.

Participant Flow:   Overall Study
    Rheumatoid Arthritis Participants
STARTED   120 
COMPLETED   108 
NOT COMPLETED   12 
Adverse Event                5 
Lack of Efficacy                4 
Abnormal laboratory parameters                1 
Unspecified                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 participants who satisfied inclusion and exclusion criteria of the study were included in the analysis.

Reporting Groups
  Description
Rheumatoid Arthritis Participants Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.

Baseline Measures
   Rheumatoid Arthritis Participants 
Overall Participants Analyzed 
[Units: Participants]
 120 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.2  (12.6) 
Gender 
[Units: Participants]
 
Female   104 
Male   16 


  Outcome Measures
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1.  Primary:   Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12   [ Time Frame: Week 12 ]

2.  Primary:   Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24   [ Time Frame: Week 24 ]

3.  Secondary:   Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F   [ Time Frame: Baseline, Week 12, Week 24 ]

4.  Secondary:   Change From Baseline to Week 12 and 24 in Serum Hemoglobin   [ Time Frame: Baseline, Week 12, 24 ]

5.  Secondary:   Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24   [ Time Frame: Week 12, 24 ]

6.  Secondary:   Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24   [ Time Frame: Week 12, 24 ]

7.  Secondary:   Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population   [ Time Frame: Week 12, 24 ]

8.  Secondary:   Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population   [ Time Frame: Week 12, 24 ]

9.  Secondary:   Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24   [ Time Frame: Baseline, Week 12, Week 24 ]

10.  Secondary:   Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population   [ Time Frame: Baseline, Week 12, 24 ]

11.  Secondary:   Change From Baseline in Duration of Morning Stiffness at Week 12, 24   [ Time Frame: Baseline, Week 12, 24 ]

12.  Secondary:   Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population   [ Time Frame: Baseline, Week 12, 24 ]

13.  Secondary:   Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24   [ Time Frame: Baseline, Week 12, 24 ]

14.  Secondary:   Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population   [ Time Frame: Baseline, Week 12, 24 ]

15.  Secondary:   Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24   [ Time Frame: Baseline, Week 12, 24 ]

16.  Secondary:   Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population   [ Time Frame: Baseline, Week 12, 24 ]

17.  Secondary:   Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24   [ Time Frame: Baseline, Week 12, 24 ]

18.  Secondary:   Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population   [ Time Frame: Baseline, Week 12, 24 ]

19.  Secondary:   Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24   [ Time Frame: Baseline, Week 12, 24 ]

20.  Secondary:   Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population   [ Time Frame: Baseline, Week 12, 24 ]

21.  Secondary:   Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24   [ Time Frame: Week 12, 24 ]

22.  Secondary:   Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population   [ Time Frame: Week 12, 24 ]


  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-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01462162     History of Changes
Other Study ID Numbers: ML27833
Study First Received: October 27, 2011
Results First Received: December 1, 2015
Last Updated: September 8, 2016
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios