Study Evaluating Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
Summary
This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.
Study Design
Time Perspective: Prospective
Conditions
Ankylosing Spondylitis
Intervention
etanercept
Location
Thessaloniki
Asvestohori
Greece
570 10
Status
Active, not recruiting
Source
Wyeth
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00273858
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Phenylbutazone
A butyl-diphenyl-pyrazolidinedione that has anti-inflammatory, antipyretic, and analgesic activities. It has been used in ANKYLOSING SPONDYLITIS; RHEUMATOID ARTHRITIS; and REACTIVE ARTHRITIS.
Etodolac
A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).
Hla-b27 Antigen
Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.
Spondylitis, Ankylosing
A chronic inflammatory condition affecting the axial joints, such as the SACROILIAC JOINT and other intervertebral or costovertebral joints. It occurs predominantly in young males and is characterized by pain and stiffness of joints (ANKYLOSIS) with inflammation at tendon insertions.
Spondylarthropathies
Heterogeneous group of arthritic diseases sharing clinical and radiologic features. They are associated with the HLA-B27 ANTIGEN and some with a triggering infection. Most involve the axial joints in the SPINE, particularly the SACROILIAC JOINT, but can also involve asymmetric peripheral joints. Subsets include ANKYLOSING SPONDYLITIS; REACTIVE ARTHRITIS; PSORIATIC ARTHRITIS; and others.
Clinical Trials
An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis
This study is an extension trial of 0881A3-312-EU and is designed to provide information on the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3 additi...
Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis
The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in An...
Extension Study Evaluating Etanercept in Ankylosing Spondylitis
The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by compar...
Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis
This study will represent the sponsor's first controlled study of etanercept in Chinese subjects with Ankylosing Spondytitis (AS). This trial is designed to assess the safety and efficacy...
16.0040 Ankylosing Spondylitis Study
The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.
PubMed Articles
This study aims to explore the effectiveness of low dose of etanercept (ETN) in patients with ankylosing spondylitis (AS) who achieve a good control of their disease in daily clinical practice. This i...
To investigate the efficacy of etanercept and MTX (methotrexate) combination therapy in Chinese patients with ankylosing spondylitis hip joint lesion, the possible courses and maintenance protocol, al...
As a measure of healthcare cost containment, the total number of vials of entanercept (25 mg) that can be prescribed for patients with inflammatory arthritis is restricted in Korea. Consequently, atte...
OBJECTIVES: Multifocal musculoskeletal inflammation is common in ankylosing spondylitis (AS) and is effectively treated by expensive anti-TNF (tumour necrosis factor) therapy. This study evaluated ass...
Etanercept pharmacokinetics in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriasis were assessed separately with distinct models using population pharmacokinetics metho...
