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

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NCT01521884

Last updated on October 12, 2019
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FOR MORE INFORMATION
Study Location
UZ Gasthuisberg
Leuven, , 3000 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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-? therapy.

Participation in other clinical or observational trials

NCT01521884
Pfizer
Completed
Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy

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[email protected]

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Descriptive Information
Brief TitleStudy Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-? Therapy
Official TitleLongitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy
Brief SummaryPeople 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 DescriptionObservational prospective study Purely descriptive
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study Populationpatients seen in a rheumatology practice
ConditionRheumatoid Arthritis
InterventionOther: SC anti-TNF
SC anti-TNF
Study Groups/CohortsRA 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 StatusCompleted
Actual Enrollment
 (submitted: February 3, 2015)		62
Original Estimated Enrollment
 (submitted: January 30, 2012)		75
Actual Study Completion DateFebruary 2014
Actual Primary Completion DateFebruary 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesBelgium
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01521884
Other Study ID Numbers0881A1-4748
B1801046 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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