Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01521884
First received: August 19, 2011
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Other: SC anti-TNF |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Longitudinal Changes in Fatigue and Health Status (aims2) in RA Patients Treated With Sc Anti-tnf-alpha Therapy (FARA-study) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Longitudinal changes in health status (AIMS2 components: Physical, Affect, Symptom, Social Interaction and Role), over two years of follow up, in a cohort of RA patients treated with SC anti-TNF-α therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Longitudinal changes in fatigue (VAS scale), over two years of follow up, in a cohort of RA patients treated with SC anti-TNF-α therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Longitudinal changes in health status (AIMS2 component Physical), over two years of follow up, in a cohort of RA patients treated with SC anti-TNF-α therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Relationship between the different components of AIMS2 and fatigue. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Relationship between the different components of AIMS2 and disease activity scores (DAS28) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Relationship between fatigue (VAS scale) and disease activity scores (DAS28) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| RA Patients treated with SC anti-TNF |
Other: SC anti-TNF
SC anti-TNF
|
Detailed Description:
Observational prospective study Purely descriptive
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
patients seen in a rheumatology practice
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-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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01521884 History of Changes |
| Other Study ID Numbers: | 0881A1-4748, B1801046 |
| Study First Received: | August 19, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013