Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy
NCT01521884
ABOUT THIS STUDY
FOR MORE INFORMATION
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Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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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Descriptive Information | ||||
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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 | 62 | |||
Original Estimated Enrollment | 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:
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 |
| |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2015 |