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
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Adult Trials: 18+ Years
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 | ||||
|---|---|---|---|---|
| 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 | |||