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An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664117
First received: August 8, 2012
Last updated: March 15, 2016
Last verified: March 2016
Results First Received: February 1, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Rheumatoid Arthritis

  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
A total of 210 participants were enrolled from 38 rheumatology units in Spain. This study was conducted between June 2012 and June 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 210 participants, one participant was excluded from the study because of past history of biologic disease-modifying antirheumatic drug (bDMARD) monotherapy under 6 months. Therefore, 209 participants were evaluated in this study.

Reporting Groups
  Description
bDMARD Monotherapy Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.

Participant Flow:   Overall Study
    bDMARD Monotherapy  
STARTED     209  
COMPLETED     209  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
bDMARD Monotherapy Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.

Baseline Measures
    bDMARD Monotherapy  
Number of Participants  
[units: participants]
  209  
Age  
[units: Years]
Mean (Standard Deviation)
  57.61  (13.59)  
Gender  
[units: Participants]
 
Female     173  
Male     36  



  Outcome Measures
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1.  Primary:   Number of Participants With Level of Education Completed   [ Time Frame: At Visit 1 (Single visit study) ]

2.  Primary:   Number of Participants With Smoking Habits   [ Time Frame: At Visit 1 ]

3.  Primary:   Smoking-habit for Smokers or Ex-smokers (Packs in Years)   [ Time Frame: At Visit 1 ]

4.  Primary:   Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )   [ Time Frame: At Visit 1 ]

5.  Primary:   Mean Time of Onset of Rheumatoid Arthritis   [ Time Frame: At Visit 1 ]

6.  Primary:   Number of Participants With Family History of Rheumatoid Arthritis   [ Time Frame: At Visit 1 ]

7.  Primary:   Number of Participants With Co-morbidities   [ Time Frame: At Visit 1 ]

8.  Primary:   Number of Participants With Extra-articular Manifestations at Visit 1   [ Time Frame: At Visit 1 ]

9.  Primary:   Mean Number of Painful and Swollen Joints at Visit 1   [ Time Frame: At Visit 1 ]

10.  Primary:   Physician’s Global Assessment of Disease Activity at Visit 1   [ Time Frame: At Visit 1 ]

11.  Primary:   Patient’s Global Assessment of Disease Activity at Visit 1   [ Time Frame: At Visit 1 ]

12.  Primary:   Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1   [ Time Frame: At Visit 1 ]

13.  Primary:   Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1   [ Time Frame: At Visit 1 ]

14.  Primary:   Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies   [ Time Frame: At Visit 1 ]

15.  Primary:   Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1   [ Time Frame: At Visit 1 ]

16.  Primary:   Patient Pain Visual Analog Scale Score at Visit 1   [ Time Frame: At Visit 1 ]

17.  Primary:   Number of Participants With Joint Damage at Visit 1   [ Time Frame: At Visit 1 ]

18.  Primary:   Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1   [ Time Frame: At Visit 1 ]

19.  Primary:   Number of Participants With Disease Activity Score by Categorization at Visit 1   [ Time Frame: At Visit 1 ]

20.  Primary:   Mean Score on Clinical Disease Activity Index at Visit 1   [ Time Frame: At Visit 1 ]

21.  Primary:   Number of Participants With Clinical Disease Activity by Categorization at Visit 1   [ Time Frame: At Visit 1 ]

22.  Primary:   Mean Score on Simple Disease Activity Index at Visit 1   [ Time Frame: At Visit 1 ]

23.  Primary:   Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1   [ Time Frame: At Visit 1 ]

24.  Secondary:   Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study   [ Time Frame: At Visit 1 ]

25.  Secondary:   Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug   [ Time Frame: At Visit 1 ]

26.  Secondary:   Number of Participants Who Received Each sDMARD Before The Study   [ Time Frame: At Visit 1 ]

27.  Secondary:   Number of Participants Who Received Last sDMARD Prescribed Before the Study   [ Time Frame: At Visit 1 ]

28.  Secondary:   Number of Participants Prescribed First bDMARD Before the Study   [ Time Frame: At Visit 1 ]

29.  Secondary:   Number of Participants Who Received Each bDMARD Before the Study   [ Time Frame: At Visit 1 ]

30.  Secondary:   Mean Time Between the Last sDMARD and bDMARD Received at Visit 1   [ Time Frame: At Visit 1 ]

31.  Secondary:   Number of Participants With Changing the Previous sDMARD/ bDMARD   [ Time Frame: At Visit 1 ]

32.  Secondary:   Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)   [ Time Frame: At Visit 1 ]

33.  Secondary:   Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment   [ Time Frame: At Visit 1 ]

34.  Secondary:   Number of Participants Discontinued the Previous Treatment and Started the Study Treatment   [ Time Frame: At Visit 1 ]

35.  Secondary:   Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment   [ Time Frame: At Visit 1 ]

36.  Secondary:   Number of Participants Treated With Concomitant Medications Before the Study   [ Time Frame: At Visit 1 ]

37.  Secondary:   Number of Participants Received Current bDMARD Treatment at the Time of the Study   [ Time Frame: At Visit 1 ]

38.  Secondary:   Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy   [ Time Frame: At Visit 1 ]

39.  Secondary:   Number of Participants With Reasons for Starting Current Biologic Monotherapy   [ Time Frame: At Visit 1 ]

40.  Secondary:   Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study   [ Time Frame: At Visit 1 ]

41.  Secondary:   Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA   [ Time Frame: At Visit 1 ]

42.  Secondary:   Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)   [ Time Frame: At Visit 1 ]

43.  Secondary:   Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study   [ Time Frame: At Visit 1 ]

44.  Secondary:   Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score   [ Time Frame: At Visit 1 ]

45.  Secondary:   Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study   [ Time Frame: At Visit 1 ]

46.  Secondary:   Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study   [ Time Frame: At Visit 1 ]

47.  Secondary:   Number of Participants With Adverse Events Leading to a Change of Treatment   [ Time Frame: At the time of change of treatment ]

48.  Secondary:   Number of Participants With Any Adverse Events and Any Serious Adverse Events   [ Time Frame: At the time of change of treatment (to the current treatment) ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01664117     History of Changes
Other Study ID Numbers: ML28356
ROC-BIO-2011-01 ( Other Identifier: Agencia Española del Medicamento y Productos Sanitarios )
Study First Received: August 8, 2012
Results First Received: February 1, 2016
Last Updated: March 15, 2016
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS)