- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289743
Etanercept (Enbrel) in Ankylosing Spondylitis (Enbrel_AS-2)
February 3, 2011 updated by: Charite University, Berlin, Germany
An Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing Spondylitis
The study has the aim to investigate the efficacy and safety of etanercept in patients with active ankylosing spondylitis (AS) over 520 weeks.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 12203
- Charite Campus Benjamin Franklin, Rheumatology
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Herne, Germany, 44652
- Rheumazentrum Ruhrgebiet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients 18 to 65 years of age.
- Proven ankylosing spondylitis according to the modified New York criteria
- 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 participatittg 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Etanercept 25 mg
Etanercept 25 mg subcutaneously twice weekly
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Etanercept 25 mg subcutaneously twice a week
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response
Time Frame: at week 12
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Achievement of at least 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 as compared to baseline
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at week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained response
Time Frame: every 3 months througout the study
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Percentage of patients achieving the BASDAI50 response over time
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every 3 months througout the study
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Safety outcome
Time Frame: at 6 and 12 weeks, every 12 weeks thereafter
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Percentage of patients experienced adverse event during the study
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at 6 and 12 weeks, every 12 weeks thereafter
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Magnetic resonance imaging (MRI) response
Time Frame: at week 24, 54, 102, 210, 308, 416, 514
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Reduction of inflammation seen on MRI in comparison to baseline
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at week 24, 54, 102, 210, 308, 416, 514
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X-ray progression
Time Frame: at week 54, 102, 210, 308, 514
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Progression of the spinal structural changes as assessed by x-ray in comparison to baseline
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at week 54, 102, 210, 308, 514
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2002
Primary Completion (ACTUAL)
September 1, 2003
Study Completion (ANTICIPATED)
May 1, 2012
Study Registration Dates
First Submitted
February 1, 2011
First Submitted That Met QC Criteria
February 3, 2011
First Posted (ESTIMATE)
February 4, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
February 4, 2011
Last Update Submitted That Met QC Criteria
February 3, 2011
Last Verified
February 1, 2002
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- Enbrel _AS-2
- 202-04 (OTHER: Ethical Commission)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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