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

NCT ID: NCT01521884

Last Updated: 2015-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-02-28

Brief Summary

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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

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Observational prospective study Purely descriptive

Conditions

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Rheumatoid Arthritis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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RA Patients treated with SC anti-TNF

SC anti-TNF

Intervention Type OTHER

SC anti-TNF

Interventions

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SC anti-TNF

SC anti-TNF

Intervention Type OTHER

Eligibility Criteria

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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-α therapy + MTX

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UZ Gasthuisberg

Leuven, , Belgium

Site Status

Countries

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Belgium

Related Links

Other Identifiers

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B1801046

Identifier Type: OTHER

Identifier Source: secondary_id

0881A1-4748

Identifier Type: -

Identifier Source: org_study_id

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