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

NCT01521884

Last updated date
Study Location
UZ Gasthuisberg
Leuven, , 3000, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients who:

- Are active RA patients (as judged by treating MD)

- Are 18 years of age or older at time of consent

- Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Use of biologics (or any experimental drug) in the last 3 months before initiation of SC
anti-TNF-α therapy.


Participation in other clinical or observational trials

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Advanced Information
Descriptive Information
Brief Title Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-? Therapy
Official Title Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy
Brief Summary People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters.
Detailed Description Observational prospective study Purely descriptive
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients seen in a rheumatology practice
Condition Rheumatoid Arthritis
Intervention Other: SC anti-TNF
SC anti-TNF
Study Groups/Cohorts RA Patients treated with SC anti-TNF
Intervention: Other: SC anti-TNF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 3, 2015)
62
Original Estimated Enrollment
 (submitted: January 30, 2012)
75
Actual Study Completion Date February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients who:

  • Are active RA patients (as judged by treating MD)
  • Are 18 years of age or older at time of consent
  • Are scheduled by their rheumatologist to initiate SC anti-TNF-? therapy + MTX

Exclusion Criteria:

Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-? therapy.

Participation in other clinical or observational trials

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT01521884
Other Study ID Numbers 0881A1-4748
B1801046 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2015