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Etanercept (Enbrel) in Undifferentiated Spondyloarthritis (Enbrel_uSpA-2)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2002 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
Rheumazentrum Ruhrgebiet
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: February 1, 2011
Last updated: February 3, 2011
Last verified: February 2002
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.

Condition Intervention Phase
Drug: Etanercept
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of Etanercept (Enbrel) Efficacy in Undifferentiated Spondyloarthritis

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 ]
    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 ]
    Percentage of patients achieving the BASDAI50 response over time

  • Safety outcome [ Time Frame: at 12 weeks, every 12 weeks thereafter ]
    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 ]
    Reduction of inflammation seen on MRI in comparison to baseline

  • 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

Enrollment: 8
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 a week
Drug: Etanercept
Etanercept 25 mg subcutaneously twice a week
Other Name: Enbrel


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

Inclusion Criteria:

  1. Patients 18 to 65 years of age.
  2. 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
  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 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.
  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
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Please refer to this study by its identifier: NCT01289730

Rheumazentrum Ruhrgebiet
Herne, Nordrhrein-Westfalen, Germany, 44649
Charite Campus Benjamin Franklin, Rheumatology
Berlin, Germany, 12203
Sponsors and Collaborators
Charite University, Berlin, Germany
Rheumazentrum Ruhrgebiet
Principal Investigator: Joachim Sieper, Prof. Dr. Charite University, Berlin, Germany
  More Information

Responsible Party: Prof. Dr. Jürgen Braun, Herne, Prof. Dr. Joachim Sieper, Berlin, Charité, Campus Benjamin Franklin, Hindenburgdamm 30. 12203 Berlin Identifier: NCT01289730     History of Changes
Other Study ID Numbers: Enbrel_uSpA-2
202-03 ( Other Identifier: Ethical Commission )
Study First Received: February 1, 2011
Last Updated: February 3, 2011

Keywords provided by Charite University, Berlin, Germany:
undifferentiated spondyloarthritis
magnetic resonance imaging

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal 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 processed this record on April 28, 2017