An Open-label Study of Etanercept (Enbrel) Efficacy in Undifferentiated Spondyloarthritis

Charite University, Berlin, Germany2 sites in 1 country8 target enrollmentFebruary 2002

ConditionsSpondyloarthritis

InterventionsEtanercept

DrugsEtanercept

Overview

Phase: Phase 2
Intervention: Etanercept
Conditions: Spondyloarthritis
Sponsor: Charite University, Berlin, Germany
Enrollment: 8
Locations: 2
Primary Endpoint: The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

May 2012

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

•Patients 18 to 65 years of age.
•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
•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 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.
•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.

Exclusion Criteria

•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
•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.

Arms & Interventions

Etanercept 25 mg

Etanercept 25 mg subcutaneously twice a week

Intervention: Etanercept

Outcomes

Primary Outcomes

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 Outcomes

Sustained response(every 3 months througout the study)
Safety outcome(at 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)