This is a Retrospective Observational Study Looking at the Characteristics and Outcomes of Participants Taking Inflectra Using the CorEvitas Rheumatoid Arthritis Registry
Study Details
Study Description
Brief Summary
This is a retrospective observational study looking at the characteristics and outcomes of participants taking Inflectra using the CorEvitas Rheumatoid Arthritis Registry.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| characteristics of patients newly initiated on Inflectra
|
Drug: Inflectra
1. To describe the characteristics of patients newly initiated on Inflectra.
|
| outcomes after initiating Inflectra
|
Drug: Inflectra
2. To describe 6-month outcomes after initiating Inflectra, among patients who have 6 months follow-up information in the CorEvitas' RA Registry.
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants achieving Low Disease Activity (LDA) [Baseline to 6 months]
Response is defined as the achievement of LDA (CDAI≤10) among patients with moderate or high disease activity (CDAI>10). CDAI = Clinical Disease Activity Index (Physician Global + Patient Global + tender joint count (TJC) + swollen joint count (SJC))
Secondary Outcome Measures
- Proportion of participants achieving clinical remission [Baseline to 6 months]
Clinical remission is defined as CDAI ≤ 2.8 Rate of response at follow up visit-achievement of remission (CDAI≤2.8) among patients with LDA, moderate, or high disease activity (CDAI>2.8) at baseline.
- Change in Clinical Disease Activity Index (CDAI) [Baseline to 6 months]
Numerical change in CDAI from baseline. Increase in number signifies worsening, decrease in number signifies improvement
- Change in Health Assessment Questionnaire (HAQ) [Baseline to 6 months]
Numerical change in HAQ (0-3)
- Change in patient pain [Baseline to 6 months]
Numerical change in patient pain Visual Analogue Scale (VAS) (0-100)
- Change in patient fatigue [Baseline to 6 months]
Numerical change in patient fatigue Visual Analogue Scale (VAS) (0-100)
- Achievement of mACR20 [Baseline to 6 months]
Achievement of mACR20 response at 6 months mACR20= Modified American College of Rheumatology 20 response is defined as an improvement of 20% or more from baseline in the number of tender joints (from an analysis of 68 joints), in the number of swollen joints (from an analysis of 66 joints), and in three of the following four domains: a patient's global assessment of arthritis activity, a physician's global assessment of arthritis activity, and a patient's assessment of arthritis pain (with all three evaluations measured on a visual-analogue scale of 0 to 100 mm, with higher scores indicating greater pain or disability); disability as measured by the HAQ-DI
- Achievement of mACR50 [Baseline to 6 months]
Achievement of mACR50 response
- Achievement of mACR70 [Baseline to 6 months]
Achievement of mACR70 response
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be at least 18 years of age
-
Have been diagnosed with RA by a rheumatologist
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Have initiated treatment with Inflectra
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Had assessment of effectiveness in patients who have at least one follow up visit.
Exclusion Criteria:
- No additional exclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer | Collegeville | Pennsylvania | United States | 19426 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C1231007