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Etanercept (Enbrel) in Ankylosing Spondylitis

Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: Etanercept (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Charite University, Berlin, Germany

Official(s) and/or principal investigator(s):
Joachim Sieper, Prof. Dr., Principal Investigator, Affiliation: Charité, Universitätsmedizin Berlin, Campus Benjamin Franklin

Summary

The study has the aim to investigate the efficacy and safety of etanercept in patients with active ankylosing spondylitis (AS) over 520 weeks.

Clinical Details

Official title: An Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing Spondylitis

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response

Secondary outcome:

Sustained response

Safety outcome

Magnetic resonance imaging (MRI) response

X-ray progression

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients 18 to 65 years of age. 2. Proven ankylosing spondylitis according to the modified New York criteria 3. 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 4. Understand, sign. and date the written informed consent at the screening visit. 5. 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. 6. 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. 7. Negative serum or urine pregnancy test taken at screen in all women except those surgically sterile or at least 1 year postmenopausal. 8. Able to self-administer injectable drug supplies or have a caregiver who will do so. 9. Able to store injectable test article at 2° to 8° C. Exclusion Criteria: 1. Pregnancy/lactation 2. Previously exposure to murine or chimeric monoclonal antibodies 3. Receipt of any live (attenuated) vaccines within 4 weeks before screening visit 4. History of chronic or a recent serious infection 5. History of tuberculosis within the last 3 years 6. History of malignancy 7. 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 8. Presence or history of confirmed blood dyscrasias 9. History of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening 10. 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. 11. Participation in trials of other investigational medications within 30 days of entering the study 12. Clinical examination showing significant abnormalities of clinical relevance 13. Concomitant medication with disease-modifying anti-rheumatic drugs (DMARDs) or corticosteroids 14. History or current evidence of abuse of "hard" drugs (eg., cocaine/heroine) or alcoholism

Locations and Contacts

Charite Campus Benjamin Franklin, Rheumatology, Berlin 12203, Germany

Rheumazentrum Ruhrgebiet, Herne 44652, Germany

Additional Information

Starting date: February 2002
Last updated: February 3, 2011

Page last updated: August 20, 2015

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