N/A
N=111
Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01877239 ↗Enrolled (actual)
111
Serious AEs
10.5%
Results posted
Dec 2018
Primary outcome: Primary: Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24 — 44.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- non-intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24 |
44.3 | — |
| SECONDARY Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 |
22.4; 50.0; 11.8; 2.6; 48.7; 19.7 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 |
25.75; -19.09; -20.45; -22.58 | — |
Summary
This is a prospective non-interventional observational study to evaluate the treatment of moderately active RA patients in every day clinical practice in Austria. Patients will be observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI remission after 24 weeks.
Eligibility Criteria
Inclusion Criteria
- The patient is eligible to receive Etanercept treatment according to the Austrian SmPC.
- The decision to treat the patient with Etanercept has been made independently by the physician and is clearly separated from the decision to include the patient in the study. The treatment decision was made in advance and is not dependent on the protocol.
- The patient was informed about the study and gave his/her consent and signed an Independent Ethics Committee (IEC) submitted written Informed Consent form on use of the data.
- The patient has moderately active RA, defined as a disease activity of CDAI >10 and ≤22 and/or DAS28 (CRP)>3.2 and ≤ 5.1
Exclusion Criteria
- Any contraindication according to the Austrian SmPC, which includes:
A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection.
- Patient has previously participated in this study.
Data sourced from ClinicalTrials.gov (NCT01877239). 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.