Etanercept (Enbrel) in Ankylosing Spondylitis

Phase 2

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Etanercept

• Registration Number: NCT01289743
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2002-02
• Study Start: 2002-02
• Primary Completion: 2003-09
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-03
• Last Update Submitted: 2011-02-03
• Study First Posted: 2011-02-04
• Last Update Posted: 2011-02-04
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etanercept 25 mg	Etanercept	Etanercept 25 mg subcutaneously twice weekly

Primary Outcome Measures

Name	Time	Method
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response	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

Name	Time	Method
Sustained response	every 3 months througout the study	Percentage of patients achieving the BASDAI50 response over time
Safety outcome	at 6 and 12 weeks, every 12 weeks thereafter	Percentage of patients experienced adverse event during the study
Magnetic resonance imaging (MRI) response	at week 24, 54, 102, 210, 308, 416, 514	Reduction of inflammation seen on MRI in comparison to baseline
X-ray progression	at week 54, 102, 210, 308, 514	Progression of the spinal structural changes as assessed by x-ray in comparison to baseline

Trial Locations

Locations (2)

Charite Campus Benjamin Franklin, Rheumatology; 🇩🇪 Berlin, Germany

Rheumazentrum Ruhrgebiet; 🇩🇪 Herne, Germany