Etanercept (Enbrel) in Ankylosing Spondylitis

NCT ID: NCT01289743

Last Updated: 2011-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2012-05-31

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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Etanercept 25 mg

Etanercept 25 mg subcutaneously twice weekly

Group Type: EXPERIMENTAL

Etanercept

Intervention Type: DRUG

Etanercept 25 mg subcutaneously twice a week

Interventions

Etanercept

Etanercept 25 mg subcutaneously twice a week

Intervention Type: DRUG

Other Intervention Names

Enbrel

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rheumazentrum Ruhrgebiet

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Charité, Campus Benjamin Franklin, Hindenburgdamm 30. 12203 Berlin

Principal Investigators

Joachim Sieper, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charite Campus Benjamin Franklin, Rheumatology

Berlin, , Germany

Rheumazentrum Ruhrgebiet

Herne, , Germany

Countries

Germany

References

Baraliakos X, Haibel H, Fritz C, Listing J, Heldmann F, Braun J, Sieper J. Long-term outcome of patients with active ankylosing spondylitis with etanercept-sustained efficacy and safety after seven years. Arthritis Res Ther. 2013;15(3):R67. doi: 10.1186/ar4244.

Reference Type: DERIVED

PMID: 23786760 (View on PubMed)

Other Identifiers

202-04

Identifier Type: OTHER

Identifier Source: secondary_id

Enbrel _AS-2

Identifier Type: -

Identifier Source: org_study_id