Etanercept (Enbrel) in Undifferentiated Spondyloarthritis (Enbrel_uSpA-2)

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

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.

Study Overview

• Status: Unknown
• Conditions: Spondyloarthritis
• Intervention / Treatment: Drug: Etanercept

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Charite Campus Benjamin Franklin, Rheumatology
  • Nordrhrein-Westfalen
    • Herne, Nordrhrein-Westfalen, Germany, 44649
      • Rheumazentrum Ruhrgebiet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Etanercept 25 mg; Etanercept 25 mg subcutaneously twice a week	Drug: Etanercept; Etanercept 25 mg subcutaneously twice a week; Other Names: Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained response	Percentage of patients achieving the BASDAI50 response over time	every 3 months througout the study
Magnetic resonance imaging (MRI) response	Reduction of inflammation seen on MRI in comparison to baseline	at week 24, 54, 102, 210, 308, 416, 514
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
Safety outcome	Percentage of patients experienced adverse event during the study	at 12 weeks, every 12 weeks thereafter

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Rheumazentrum Ruhrgebiet

Study record dates

Study Major Dates

• Study Start: February 1, 2002
• Primary Completion (Actual): September 1, 2003
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): February 4, 2011
• Last Update Submitted That Met QC Criteria: February 3, 2011
• Last Verified: February 1, 2002

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; therapy; etanercept; undifferentiated spondyloarthritis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: Enbrel_uSpA-2; 202-03 (Other Identifier: Ethical Commission)