Etanercept (Enbrel) in Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01289743
• Date of registration: 01/02/2011
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Etanercept (Enbrel) in Ankylosing Spondylitis Enbrel_AS-2
• Scientific title: An Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing Spondylitis
• Date of first enrolment: February 2002
• Target sample size: 24
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01289743
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Joachim Sieper, Prof. Dr.
• Affiliation: Charité, Universitätsmedizin Berlin, Campus Benjamin Franklin

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Etanercept

Primary Outcome(s)

The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response [Time Frame: at week 12]

Secondary Outcome(s)

X-ray progression [Time Frame: at week 54, 102, 210, 308, 514]

Magnetic resonance imaging (MRI) response [Time Frame: at week 24, 54, 102, 210, 308, 416, 514]

Safety outcome [Time Frame: at 6 and 12 weeks, every 12 weeks thereafter]

Sustained response [Time Frame: every 3 months througout the study]

Secondary ID(s)

202-04

Enbrel _AS-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Rheumazentrum Ruhrgebiet