NCT00503139

Enbrel Special Use Result Surveillance

Completed Results posted Last updated 9 January 2017

What this trial tests

trial testing Enbrel (etanercept) in Rheumatoid Arthritis in 684 participants. Completed in 1 April 2013.

Timeline

1 July 2007

Primary endpoint
1 April 2013

1 April 2013

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	684
Start date	1 July 2007
Primary completion	1 April 2013
Estimated completion	1 April 2013
Sites	1 location across Japan

Drugs / interventions tested

• Enbrel (etanercept) — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Pfizer — full company profile →

Who can join

10 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants in Safety Analysis Population of Etanercept
  Time frame: 3 years
• Number of Participants With Treatment Related Adverse Events of Etanercept
  Time frame: 3 years
  Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.
• Number of Participants With Serious Treatment Related Adverse Events of Etanercept
  Time frame: 3 years
  Serious treatment-related adverse events are defined as any events that lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.
• Number of Participants With Unlisted Treatment Related Adverse Events of Etanercept
  Time frame: 3 years
  Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment related adverse events were confirmed with lis
• European League Against Rheumatism (EULAR) Disease Activity Score (DAS) 28 Improvement (4/Erythrocyte Sedimentation Rate: ESR)
  Time frame: 2 years
  DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.

Sponsor's own description

The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Three-year safety and two-year effectiveness of etanercept in patients with rheumatoid arthritis in Japan: Results of long-term postmarketing surveillance.
   Yamanaka H, Hirose T, Endo Y, Sugiyama N, et al · · 2019 · cited 7× · PMID 30092161 · DOI 10.1080/14397595.2018.1510759