Etanercept (Enbrel) in Ankylosing Spondylitis (Enbrel_AS-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01289743
Recruitment Status : Unknown
Verified February 2002 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : February 4, 2011
Last Update Posted : February 4, 2011
Rheumazentrum Ruhrgebiet
Information provided by:
Charite University, Berlin, Germany

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

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Etanercept Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing Spondylitis
Study Start Date : February 2002
Actual Primary Completion Date : September 2003
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: Etanercept 25 mg
Etanercept 25 mg subcutaneously twice weekly
Drug: Etanercept
Etanercept 25 mg subcutaneously twice a week
Other Name: Enbrel

Primary Outcome Measures :
  1. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response [ Time Frame: at week 12 ]
    Achievement of at least 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 as compared to baseline

Secondary Outcome Measures :
  1. Sustained response [ Time Frame: every 3 months througout the study ]
    Percentage of patients achieving the BASDAI50 response over time

  2. Safety outcome [ Time Frame: at 6 and 12 weeks, every 12 weeks thereafter ]
    Percentage of patients experienced adverse event during the study

  3. Magnetic resonance imaging (MRI) response [ Time Frame: at week 24, 54, 102, 210, 308, 416, 514 ]
    Reduction of inflammation seen on MRI in comparison to baseline

  4. X-ray progression [ Time Frame: at week 54, 102, 210, 308, 514 ]
    Progression of the spinal structural changes as assessed by x-ray in comparison to baseline

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01289743

Charite Campus Benjamin Franklin, Rheumatology
Berlin, Germany, 12203
Rheumazentrum Ruhrgebiet
Herne, Germany, 44652
Sponsors and Collaborators
Charite University, Berlin, Germany
Rheumazentrum Ruhrgebiet
Principal Investigator: Joachim Sieper, Prof. Dr. Charite University, Berlin, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Dr. Jürgen Braun, Herne, Prof. Dr. Joachim Sieper, Berlin, Charité, Campus Benjamin Franklin, Hindenburgdamm 30. 12203 Berlin Identifier: NCT01289743     History of Changes
Other Study ID Numbers: Enbrel _AS-2
202-04 ( Other Identifier: Ethical Commission )
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: February 4, 2011
Last Verified: February 2002

Keywords provided by Charite University, Berlin, Germany:
ankylosing spondylitis
magnetic resonance imaging

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors