---
title: Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria
nct_id: NCT01877239
overall_status: COMPLETED
sponsor: Pfizer
study_type: OBSERVATIONAL
primary_condition: Rheumatoid Arthritis
countries: Austria
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01877239.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01877239"
ct_last_update_post_date: 2018-12-03
last_seen_at: "2026-05-12T07:13:56.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria

**Official Title:** A Multicenter Non-interventional Study To Observe The Safety And Efficacy Of Etanercept (Enbrel (Registered)) In Patients With Moderately Active Rheumatoid Arthritis In Every Day Clinical Practice In Austria

**NCT ID:** [NCT01877239](https://clinicaltrials.gov/study/NCT01877239)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 111
- **Lead Sponsor:** Pfizer
- **Conditions:** Rheumatoid Arthritis
- **Start Date:** 2012-12-10
- **Completion Date:** 2016-06-14
- **CT.gov Last Update:** 2018-12-03

## Brief 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.

## Detailed Description

Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. The patient is eligible to receive Etanercept treatment according to the Austrian SmPC.
2. 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.
3. 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.
4. 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:

1. Any contraindication according to the Austrian SmPC, which includes:

   A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection.
2. Patient has previously participated in this study.
```

## Arms

- **Full Analysis Set** — Full Analysis Set (FAS): The FAS contains any patient that has given written informed consent.

## Interventions

- **non-intervention** (OTHER) — observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC

## Primary Outcomes

- **Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24** _(time frame: Week 24)_ — CDAI is a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (\<=) 2.8 indicates disease remission, greater than (\>) 2.8 to 10 = low disease activity, greater than (\>) 10 to 22 = moderate disease activity, and \>22 = high disease activity. Percentage of participants with CDAI remission (score \<=2.8) at Week 24 were reported.

## Secondary Outcomes

- **Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52** _(time frame: Week 12 and Week 52)_
- **Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52** _(time frame: Baseline, Week 12, Week 24, Week 52)_

## Locations (10)

- Ordination Dr. Thomas Muller, Graz, Austria
- Barmherzige Brüder Graz Eggenberg, Graz, Austria
- Ordination Dr. Horst Just, Klagenfurt, Austria
- Ordination Dr. Richard Janetschko, Linz, Austria
- Ordination Dr. Wilhelm Kaiser, Linz, Austria
- Dr. Eichbauer-Sturm, Linz, Austria
- Rheumazentrum Oberlaa, Vienna, Austria
- Ordination Dr. Peter Peichl, Vienna, Austria
- Ordination Dr. Maya Thun, Vienna, Austria
- Ordination Dr. Thomas Schwingenschlogl, Wiener Neudorf, Austria

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ordination dr. thomas muller|graz||austria` — added _(2026-05-12)_
- `locations.barmherzige brüder graz eggenberg|graz||austria` — added _(2026-05-12)_
- `locations.ordination dr. horst just|klagenfurt||austria` — added _(2026-05-12)_
- `locations.ordination dr. richard janetschko|linz||austria` — added _(2026-05-12)_
- `locations.ordination dr. wilhelm kaiser|linz||austria` — added _(2026-05-12)_
- `locations.dr. eichbauer-sturm|linz||austria` — added _(2026-05-12)_
- `locations.rheumazentrum oberlaa|vienna||austria` — added _(2026-05-12)_
- `locations.ordination dr. peter peichl|vienna||austria` — added _(2026-05-12)_
- `locations.ordination dr. maya thun|vienna||austria` — added _(2026-05-12)_
- `locations.ordination dr. thomas schwingenschlogl|wiener neudorf||austria` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01877239.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01877239*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*