ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01521884
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Rheumatoid Arthritis
Intervention: Other: SC anti-TNF

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.

Participant Flow:   Overall Study
    Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)
STARTED   62 
COMPLETED   35 
NOT COMPLETED   27 
Non Responders                10 
Adverse Event                5 
Pregnancy                1 
Withdrawal by Subject                1 
Physician Decision                2 
Protocol Violation                3 
Participant non-eligible                1 
Lost to Follow-up                4 



  Baseline Characteristics

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.
Intention to treat (ITT) population included all participants for whom the primary endpoint or one of the secondary endpoints could be determined at baseline. Here “N” (Overall Number of Baseline Participants) includes participants with non-missing baseline data.

Reporting Groups
  Description
Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.

Baseline Measures
   Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) 
Overall Participants Analyzed 
[Units: Participants]
 61 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.2  (11.28) 
Gender 
[Units: Participants]
 
Female   46 
Male   15 


  Outcome Measures

1.  Primary:   Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline   [ Time Frame: Baseline ]

2.  Primary:   Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6   [ Time Frame: Month 6 ]

3.  Primary:   Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12   [ Time Frame: Month 12 ]

4.  Primary:   Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18   [ Time Frame: Month 18 ]

5.  Primary:   Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24   [ Time Frame: Month 24 ]

6.  Secondary:   Visual Analog Scale (VAS) Fatigue Score   [ Time Frame: Baseline, Month 6, 12, 18, 24 ]

7.  Secondary:   Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)   [ Time Frame: Baseline, Month 6, 12, 18, 24 ]

8.  Secondary:   Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)   [ Time Frame: Baseline, Month 6, 12, 18, 24 ]

9.  Secondary:   Health Assessment Questionnaire (HAQ) Total Score   [ Time Frame: Baseline, Month 6, 12, 18, 24 ]

10.  Other Pre-specified:   Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score   [ Time Frame: Baseline, Month 6, 12, 18, 24 ]

11.  Other Pre-specified:   Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)   [ Time Frame: Baseline, Month 6,1 2, 18, 24 ]

12.  Other Pre-specified:   Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)   [ Time Frame: Baseline, Month 6, 12, 18, 24 ]

13.  Other Pre-specified:   Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score   [ Time Frame: Baseline, Month 6, 12, 18, 24 ]

14.  Other Pre-specified:   Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score   [ Time Frame: Baseline, Month 6, 12, 18, 24 ]


  Serious Adverse Events


  Other Adverse Events


  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
Designation of primary and secondary endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.


  More Information

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01521884     History of Changes
Other Study ID Numbers: 0881A1-4748
B1801046 ( Other Identifier: Alias Study Number )
First Submitted: August 19, 2011
First Posted: January 31, 2012
Results First Submitted: February 3, 2015
Results First Posted: February 19, 2015
Last Update Posted: February 19, 2015