Etanercept (Enbrel) in Undifferentiated Spondyloarthritis

Study Overview
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Brief Summary
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The study has the aim to investigate the efficacy and safety of etanercept in patients with active undifferentiated spondyloarthritis (uSpA) over the period of 520 weeks.

Official Title
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An Open-label Study of Etanercept (Enbrel) Efficacy in Undifferentiated Spondyloarthritis

Conditions
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Spondyloarthritis

Intervention / Treatment
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* Drug: Etanercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 to 65 years of age. Proven undifferentiated spondyloarthritis according to the European Spondylarthropathy Study Group (ESSG) criteria who do not have ankylosing spondylitis, reactive arthritis, psoriasis and/or inflammatory bowel disease Acute phase of disease with high disease activity the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 or a pain score ≥ 4 on a Numeric Rating Scale (NRS) at two occasions in 2 weeks Understand, sign and date the written informed consent at the screening visit. Sexually active women participating in the study must use a medically acceptable form of contraception until 6 month after the last injection of study medication. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy. Sexually active men must agree to use a medically accepted form of contraception during the study until 6 month after the last injection of study medication. Negative serum or urine pregnancy test taken at screen in all women except those surgically sterile or at least 1 year postmenopausal. Able to self-administer injectable drug supplies or have a caregiver who will do so. Able to store injectable test article at 2° to 8° C. Exclusion Criteria: Pregnancy/lactation Previously exposure to murine or chimeric monoclonal antibodies Receipt of any live (attenuated) vaccines within 4 weeks before screening visit History of chronic or a recent serious infection History of tuberculosis within the last 3 years History of malignancy Significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection, central nervous system demyelinating events suggestive of multiple sclerosis Presence or history of confirmed blood dyscrasias History of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening Laboratory exclusions are: hemoglobin level < 8,5 mg/dl white blood cell count < 3.5 x 10^9/l platelet count < 125 x 10^9 /l creatinine level > 175 mcmol/l, liver enzymes > 1.5 times the upper limit of normal or alkaline phosphatase > 2 times the upper limit of normal. Participation in trials of other investigational medications within 30 days of entering the study Clinical examination showing significant abnormalities of clinical relevance Concomitant medication with disease-modifying anti-rheumatic drugs (DMARDs) or corticosteroids History or current evidence of abuse of hard drugs (eg., cocaine/heroine) or alcoholism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etanercept 25 mg<br>Etanercept 25 mg subcutaneously twice a week | Drug: Etanercept<br>* Etanercept 25 mg subcutaneously twice a week<br>* Other names: Enbrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response | Achievement of at least 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 as compared to baseline | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained response | Percentage of patients achieving the BASDAI50 response over time | every 3 months througout the study | 
| Safety outcome | Percentage of patients experienced adverse event during the study | at 12 weeks, every 12 weeks thereafter | 
| Magnetic resonance imaging (MRI) response | Reduction of inflammation seen on MRI in comparison to baseline | at week 24, 54, 102, 210, 308, 416, 514 | 
| X-ray progression | Progression of the spinal structural changes as assessed by x-ray in comparison to baseline | at week 54, 102, 210, 308, 514 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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undifferentiated spondyloarthritis, etanercept, therapy, magnetic resonance imaging