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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877239
• Other study ID #: B1801357
• Status: Completed
• Start date: December 10, 2012
• Est. completion date: June 14, 2016

Study information

• Verified date: April 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 14, 2016
• Est. primary completion date: January 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• non-intervention
observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at 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.	Week 24
Secondary	Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52	CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, 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 <= 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Percentage of participants with different type of CDAI status of disease activity (remission, low disease, moderate and high disease activity) at Week 12 and 52 were reported. Only those categories in which at least 1 participant had data were reported.	Week 12 and Week 52
Secondary	Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52	CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, 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 <= 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.	Baseline, Week 12, Week 24, Week 52

External Links

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