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Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose) (DOSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00794118
First received: November 17, 2008
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
Results First Received: April 12, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Rheumatoid Arthritis
Intervention: Other: As per clinical practice

  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
Anti-tumor Necrosis Factor (Anti-TNF) Agents Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.

Participant Flow:   Overall Study
    Anti-tumor Necrosis Factor (Anti-TNF) Agents  
STARTED     299  
COMPLETED     272  
NOT COMPLETED     27  
Lost to Follow-up                 16  
Withdrawal by Subject                 9  
Changed hospital center                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Anti-tumor Necrosis Factor (Anti-TNF) Agents Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.

Baseline Measures
    Anti-tumor Necrosis Factor (Anti-TNF) Agents  
Number of Participants  
[units: participants]
 		  299  
Age, Customized  
[units: Participants]
 		 
18 to 34 years     29  
35 to 49 years     72  
50 to 64 years     133  
Greater than or equal to (>=) 65 years     65  
Gender  
[units: Participants]
 		 
Female     230  
Male     69  
Percentage of participants with Disease Activity Score Based on 28-joints count (DAS28) remission [1]
[units: Percentage of participants]
 		  1.7  
Disease Activity Score Based on 28-joints count (DAS28) [2]
[units: Units on  a scale]
Mean ± Standard Deviation 		  5.4  ± 1.2  
Patient Global Assessment (PtGA) [3]
[units: centimeter (cm)]
Mean ± Standard Deviation 		  6.6  ± 2.1  
Physician Global Assessment (PGA) [4]
[units: cm]
Mean ± Standard Deviation 		  6.1  ± 1.7  
Visual Analogue Scale for Pain (VAS-pain) [5]
[units: cm]
Mean ± Standard Deviation 		  6.7  ± 2.2  
C-reactive Protein (CRP) [6]
[units: milligram/deciliter (mg/dL)]
Mean ± Standard Deviation 		  3.3  ± 6.3  
Erythrocyte Sedimentation Rate (ESR) [7]
[units: millimeter/hour (mm/hr)]
Mean ± Standard Deviation 		  32.9  ± 22.0  
Rheumatoid Factor (RF) [8]
[units: Participants]
 		 
Positive     163  
Negative     118  
Not available (NA)     18  
Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies [9]
[units: Participants]
 		 
Positive     124  
Negative     97  
NA     78  
Anti-nuclear antibodies [10]
[units: Participants]
 		 
Positive     38  
Negative     170  
NA     91  
Anti-deoxyribonucleic Acid (Anti-DNA) antibodies [11]
[units: Participants]
 		 
Positive     6  
Negative     173  
NA     120  
Duration of morning stiffness [12]
[units: minutes]
Mean ± Standard Deviation 		  61.8  ± 48.0  
Stanford Health Assessment Questionnaire (HAQ) [13]
[units: Units on a scale]
Mean ± Standard Deviation 		  1.4  ± 0.7  
36-Item Short-Form Health Survey (SF-36) [14]
[units: Units on a Scale]
Mean ± Standard Deviation 		 
Indice sintetico salute fisica del (ISF)     38.8  ± 10.6  
Indice sintetico salute mentale del (ISM)     48.0  ± 13.2  
Disease duration  
[units: Years]
Median ( Inter-Quartile Range ) 		  5.0  
  ( 2.0 to 10.0 )  
Number of tender joints [15]
[units: Tender joints]
Mean ± Standard Deviation 		  11.0  ± 7.1  
Number of swollen joints (SJC) [16]
[units: Swollen joints]
Mean ± Standard Deviation 		  7.3  ± 5.3  
Percentage of participants given Disease Modifying Anti-Rheumatoid Drugs (DMARD)  
[units: Percentage of participants]
 		  98.3  
[1] DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the ESR and PtGA of disease activity. DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.
[2] DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR and PtGA of disease activity. DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Number of participants analyzed (N)=272 for this parameter.
[3] PtGA measured using a 10 cm Visual Analog Scale (VAS) ranging from 0 cm = very good to 10 cm = very bad.
[4] PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
[5] 10 cm line (VAS) marked by participant. Intensity of pain range: 0 cm = no pain to 10 cm = worst possible pain.
[6] CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. Number of participants analyzed (N) = 272 for this parameter.
[7] ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
[8] RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 unit/milliliter (U/mL) is considered positive.
[9] Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
[10] Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
[11] Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
[12] Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
[13] HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Average score range: 0 to 3.
[14] SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
[15] The mean number of tender joints was evaluated based on the number of tender joints in a standard 28 joint count.
[16] The mean number of swollen joints was evaluated based on the number of swollen joints in a standard 28 joint count.



  Outcome Measures
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1.  Primary:   Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 2

3.  Primary:   Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 3

4.  Primary:   Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 4

5.  Primary:   Disease Activity Score Based on 28-joints Count (DAS28) at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 5

6.  Primary:   Disease Activity Score Based on 28-joints Count (DAS28) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 6

7.  Primary:   Disease Activity Score Based on 28-joints Count (DAS28) at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 7

8.  Primary:   Disease Activity Score Based on 28-joints Count (DAS28) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 8

9.  Primary:   Patient Global Assessment (PtGA) of Disease Activity Score at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 9

10.  Primary:   Patient Global Assessment (PtGA) of Disease Activity Score at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 10

11.  Primary:   Patient Global Assessment (PtGA) of Disease Activity Score at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 11

12.  Primary:   Patient Global Assessment (PtGA) of Disease Activity Score at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 12

13.  Primary:   Physician Global Assessment (PGA) of Disease Activity at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 13

14.  Primary:   Physician Global Assessment (PGA) of Disease Activity at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 14

15.  Primary:   Physician Global Assessment (PGA) of Disease Activity at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 15

16.  Primary:   Physician Global Assessment (PGA) of Disease Activity at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 16

17.  Primary:   Visual Analogue Scale for Pain (VAS-pain) at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 17

18.  Primary:   Visual Analogue Scale for Pain (VAS-pain) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 18

19.  Primary:   Visual Analogue Scale for Pain (VAS-pain) at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 19

20.  Primary:   Visual Analogue Scale for Pain (VAS-pain) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 20

21.  Primary:   C-reactive Protein (CRP) at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 21

22.  Primary:   C-reactive Protein (CRP) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 22

23.  Primary:   C-reactive Protein (CRP) at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 23

24.  Primary:   C-reactive Protein (CRP) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 24

25.  Primary:   Erythrocyte Sedimentation Rate (ESR) at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 25

26.  Primary:   Erythrocyte Sedimentation Rate (ESR) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 26

27.  Primary:   Erythrocyte Sedimentation Rate (ESR) at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 27

28.  Primary:   Erythrocyte Sedimentation Rate (ESR) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 28

29.  Primary:   Number of Participants With Rheumatoid Factor (RF) at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 29

30.  Primary:   Number of Participants With Rheumatoid Factor (RF) at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 30

31.  Primary:   Number of Participants With Rheumatoid Factor (RF) at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 31

32.  Primary:   Number of Participants With Rheumatoid Factor (RF) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 32

33.  Primary:   Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 33

34.  Primary:   Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 34

35.  Primary:   Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 35

36.  Primary:   Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 36

37.  Primary:   Number of Participants With Anti-nuclear Antibodies at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 37

38.  Primary:   Number of Participants With Anti-nuclear Antibodies at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 38

39.  Primary:   Number of Participants With Anti-nuclear Antibodies at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 39

40.  Primary:   Number of Participants With Anti-nuclear Antibodies at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 40

41.  Primary:   Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 41

42.  Primary:   Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 42

43.  Primary:   Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 43

44.  Primary:   Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 44

45.  Primary:   Duration of Morning Stiffness at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 45

46.  Primary:   Duration of Morning Stiffness at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 46

47.  Primary:   Duration of Morning Stiffness at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 47

48.  Primary:   Duration of Morning Stiffness at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 48

49.  Primary:   Stanford Health Assessment Questionnaire (HAQ) Score at Month 3   [ Time Frame: Month 3 ]
  Show Outcome Measure 49

50.  Primary:   Stanford Health Assessment Questionnaire (HAQ) Score at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 50

51.  Primary:   Stanford Health Assessment Questionnaire (HAQ) Score at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 51

52.  Primary:   Stanford Health Assessment Questionnaire (HAQ) Score at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 52

53.  Primary:   36-Item Short-Form Health Survey (SF-36) at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 53

54.  Secondary:   Direct Costs   [ Time Frame: Baseline, Months 3, 6, 9 and 12 ]
Results not yet posted.   Anticipated Posting Date:   08/2012   Safety Issue:   No

55.  Secondary:   Indirect Costs   [ Time Frame: Baseline, Months 3, 6, 9 and 12 ]
Results not yet posted.   Anticipated Posting Date:   08/2012   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00794118     History of Changes
Other Study ID Numbers: 0881A1-102321, B1801119
Study First Received: November 17, 2008
Results First Received: April 12, 2012
Last Updated: April 12, 2012
Health Authority: Italy: Ethics Committee