N/A
Completed N=62
Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy
Source: ClinicalTrials.gov NCT01521884 ↗Enrolled (actual)
62
Serious AEs
1.6%
Results posted
Feb 2015
Primary outcomePrimary: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline — 3.5; 4.8; 7.3 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline |
3.5; 4.8; 7.3 | — |
| PRIMARY Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6 |
2.3; 3.8; 5.1 | — |
| PRIMARY Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12 |
2.1; 3.5; 4.3 | — |
| PRIMARY Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18 |
2.6; 3.4; 4.5 | — |
| PRIMARY Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24 |
2.2; 3.2; 3.8 | — |
| SECONDARY Visual Analog Scale (VAS) Fatigue Score |
6.4; 4.7; 4.4; 4.3; 4.6 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR) |
4.93; 3.21; 3.05; 3.04; 2.44 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) |
4.59; 2.50; 2.75; 2.59; 2.35 | — |
| SECONDARY Health Assessment Questionnaire (HAQ) Total Score |
30.17; 22.99; 22.45; 23.60; 22.84 | — |
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-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
Data sourced from ClinicalTrials.gov (NCT01521884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.