Etanercept (Enbrel) in Undifferentiated Spondyloarthritis

Spondyloarthritis Clinical Trial

— Enbrel_uSpA-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01289730
• Other study ID #: Enbrel_uSpA-2
• Secondary ID: 202-03
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 1, 2011
• Last updated: February 3, 2011
• Start date: February 2002
• Est. completion date: May 2012

Study information

• Verified date: February 2002
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: May 2012
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients 18 to 65 years of age.

2. 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

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 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.

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

Drug:
• Etanercept
Etanercept 25 mg subcutaneously twice a week

Locations

Country	Name	City	State
Germany	Charite Campus Benjamin Franklin, Rheumatology	Berlin
Germany	Rheumazentrum Ruhrgebiet	Herne	Nordrhrein-Westfalen

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Rheumazentrum Ruhrgebiet

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Sustained response	Percentage of patients achieving the BASDAI50 response over time	every 3 months througout the study	No
Secondary	Safety outcome	Percentage of patients experienced adverse event during the study	at 12 weeks, every 12 weeks thereafter	Yes
Secondary	Magnetic resonance imaging (MRI) response	Reduction of inflammation seen on MRI in comparison to baseline	at week 24, 54, 102, 210, 308, 416, 514	No
Secondary	X-ray progression	Progression of the spinal structural changes as assessed by x-ray in comparison to baseline	at week 54, 102, 210, 308, 514	No