Etanercept (Enbrel) in Ankylosing Spondylitis

NCT01289743 | Unknown Phase 2 DMC

• 2 other identifiers: Enbrel _AS-2202-04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Keywords

ankylosing spondylitis; atanercept; therapy; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response

  Achievement of at least 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 as compared to baseline

  at week 12

Secondary Outcomes (4)

• Sustained response

  every 3 months througout the study

• Safety outcome

  at 6 and 12 weeks, every 12 weeks thereafter

• Magnetic resonance imaging (MRI) response

  at week 24, 54, 102, 210, 308, 416, 514

• X-ray progression

  at week 54, 102, 210, 308, 514

Study Arms (1)

Etanercept 25 mg

EXPERIMENTAL

Etanercept 25 mg subcutaneously twice weekly

Drug: Etanercept

Interventions

Etanercept DRUG

Etanercept 25 mg subcutaneously twice a week

Also known as: Enbrel

Etanercept 25 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 to 65 years of age.
• Proven ankylosing spondylitis according to the modified New York criteria
• 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
• Understand, sign. and date the written informed consent at the screening visit.
• 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.
• 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.
• Negative serum or urine pregnancy test taken at screen in all women except those surgically sterile or at least 1 year postmenopausal.
• Able to self-administer injectable drug supplies or have a caregiver who will do so.
• Able to store injectable test article at 2° to 8° C.

You may not qualify if:

• Pregnancy/lactation
• Previously exposure to murine or chimeric monoclonal antibodies
• Receipt of any live (attenuated) vaccines within 4 weeks before screening visit
• History of chronic or a recent serious infection
• History of tuberculosis within the last 3 years
• History of malignancy
• 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
• Presence or history of confirmed blood dyscrasias
• History of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening
• Participation in trials of other investigational medications within 30 days of entering the study
• Clinical examination showing significant abnormalities of clinical relevance
• Concomitant medication with disease-modifying anti-rheumatic drugs (DMARDs) or corticosteroids
• History or current evidence of abuse of "hard" drugs (eg., cocaine/heroine) or alcoholism

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Rheumazentrum Ruhrgebiet: collaborator

Study Sites (2)

Charite Campus Benjamin Franklin, Rheumatology

Berlin, 12203, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44652, Germany

Location

Related Publications (1)

• 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.

  PMID: 23786760 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Joachim Sieper, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 4, 2011
• Study Start: February 1, 2002
• Primary Completion: September 1, 2003
• Study Completion: May 1, 2012
• Last Updated: February 4, 2011

Record last verified: 2002-02

Locations

DE (2)