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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2002 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Rheumazentrum Ruhrgebiet
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01289743
First received: February 1, 2011
Last updated: February 3, 2011
Last verified: February 2002
  Purpose

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


Condition Intervention Phase
Ankylosing Spondylitis
Drug: Etanercept
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
    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:
  • Sustained response [ Time Frame: every 3 months througout the study ] [ Designated as safety issue: No ]
    Percentage of patients achieving the BASDAI50 response over time

  • Safety outcome [ Time Frame: at 6 and 12 weeks, every 12 weeks thereafter ] [ Designated as safety issue: Yes ]
    Percentage of patients experienced adverse event during the study

  • Magnetic resonance imaging (MRI) response [ Time Frame: at week 24, 54, 102, 210, 308, 416, 514 ] [ Designated as safety issue: No ]
    Reduction of inflammation seen on MRI in comparison to baseline

  • X-ray progression [ Time Frame: at week 54, 102, 210, 308, 514 ] [ Designated as safety issue: No ]
    Progression of the spinal structural changes as assessed by x-ray in comparison to baseline


Enrollment: 24
Study Start Date: February 2002
Estimated Study Completion Date: May 2012
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etanercept 25 mg
Etanercept 25 mg subcutaneously twice weekly
Drug: Etanercept
Etanercept 25 mg subcutaneously twice a week
Other Name: Enbrel

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289743

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

No publications provided

Responsible Party: Prof. Dr. Jürgen Braun, Herne, Prof. Dr. Joachim Sieper, Berlin, Charité, Campus Benjamin Franklin, Hindenburgdamm 30. 12203 Berlin
ClinicalTrials.gov Identifier: NCT01289743     History of Changes
Other Study ID Numbers: Enbrel _AS-2, 202-04
Study First Received: February 1, 2011
Last Updated: February 3, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
TNFR-Fc fusion protein
Immunoglobulin G
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 20, 2014