Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: etanercept; etanercept/placebo
Intervention description: Etanercept 50 mg twice a week (BIW) for 12 weeks; Etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Effect of etanercept in subjects with ankylosing spondylitis

Summary:

      The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg
      twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis
      (AS) and previous failure to usual practice therapies in Spain.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of ankylosing spondylitis, as defined by Modified New York Criteria for
             Ankylosing Spondylitis.

          2. Maintained inflammatory activity for more than 12 weeks defined by:·Axial forms:
             BASDAI higher than or equal to 4 (0-10) and at least one of the following parameters:.
             Global assessment of the disease by the patient higher than or equal to 4 (On a scale
             0-10). Spinal pain higher than or equal to 4 on a visual analogue scale (VAS).
             Increase in erythrocyte sedimentation rate (ESR) and/or CRP above the normality
             parameters established by the laboratory.·Peripheral forms: Arthritis or enthesitis
             higher than or equal to 1 site and at least one of the following:. Global assessment
             of the disease by the patient higher than or equal to 4 (on a scale 0-10). Increase in
             erythrocyte sedimentation rate (ESR) and/or CRP above the normality parameters
             established by the laboratory

          3. Failure to treatment: Failure to at least 2 NSAIDs at maximum recommended dose during
             at least 3 months (or a shorter time in case of intolerance, toxicity or
             contraindication).·In cases of ankylosing spondylitis with peripheral joint
             involvement, salazopyrine should have been used at a dose of 2-3 g per day and/or
             methotrexate (15 mg/week) for 4 months (or a shorter time in case of intolerance,
             toxicity or contraindication). In case of oligoarticular or localized involvement in
             enthesis: lack of response, at the discretion of the investigator, to local
             infiltrations and/or synoviorthesis.

          4. Be between 18-70 years of age

          5. Negative result of a pregnancy test in serum in screening visit and in urine in
             baseline visit, done in all women, except those surgically sterilized and those who
             have at least one year of menopause.

          6. Sexually active women of childbearing potential must use medically acceptable
             contraceptive methods, including oral, injectable or implantable contraceptive
             methods, intrauterine devices or properly used barrier contraception. A woman of
             childbearing potential is defined as one who is biologically capable of becoming
             pregnant. This includes women who are using contraceptives or whose sexual partners
             are either sterile or using contraceptives.

          7. Men who are not surgically sterile should agree to use reliable contraceptive methods
             during the study.

          8. Ability to reconstitute the drug and self-inject it or have a person who can do so.

          9. Capability to understand and voluntarily give written informed consent that is signed
             and dated, before any specific procedure of the protocol is performed.

         10. Ability to store injectable test article at 2º to 8º C.

        Exclusion criteria:

          1. Contraindications for treatment with anti-TNF

          2. Complete ankylosis of spine

          3. Onset of treatment with DMARDs in the 4 weeks prior to baseline (SSZ, MTX and HCQ are
             permitted if the administrated dose has been maintained stable in the 4 weeks prior to
             baseline). Furthermore, patients with a dose of prednisone >10 mg/d or equivalent or
             modified in the 2 weeks prior to the baseline visit, those in whose infiltration has
             been performed with intraarticular corticosteroids has been performed in the 4 weeks
             prior to the screening visit and those who follow treatment with more than one NSAID
             in the 2 weeks prior to the baseline visit are excluded.

          4. Previous treatment with other TNF inhibitors and other biological drugs

          5. Abnormalities in hematology profiles defined by:

               -  leukocytes lower than or equal to 3.5 x 10 exponent 9 /L

               -  hemoglobin lower than or equal to 8.5 g/L or 5.3 mmol/L

               -  hematocrit lower than or equal to 27%

               -  platelets lower than or equal to 125 x 10 exponent 9 /L

               -  serum creatinine higher than or equal to 175 mmol/L

               -  aspartate aminotransferase and alanine aminotransferase higher than or equal to 2
                  times the upper limit of normality

          6. Important concomitant medical conditions, such as:-Class III or IV congestive heart
             failure according to New York Heart Association classification-Uncontrolled arterial
             hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening
             diastolic blood pressure > 100 mm Hg)-Myocardial infarction within 12 months of the
             screening visit or unstable angina-Severe pulmonary disease requiring hospitalization
             or oxygen therapy-Diagnosis of multiple sclerosis or other central nervous system
             demyelinating disease -Presence or history of confirmed blood dyscrasias-Cancer or
             history of cancer (other than resected cutaneous basal cell or squamous cell
             carcinoma)-Serious infection (infection requiring hospitalization and/or intravenous
             antibiotics) within 1 month of administration of test article administration or active
             infection at screening or history of recurrent or chronic infection-Open cutaneous
             ulcers-Patients with known chronic infections as positivity to HIV, hepatitis B
             surface antigen (HBsAg), or hepatitis C virus (HCV) -Active tuberculosis infection
             (local guidelines for appropriate screening and treatment of tuberculosis in the
             setting of anti-TNF therapy must be followed)- Any condition that, in the
             investigator's judgment, might cause this study to be detrimental to the subject

          7. Pregnant or breast-feeding women

          8. Past or current psychiatric illness that would interfere with the subject's ability to
             comply with protocol requirements or give informed consent.

          9. Treatment with any live (attenuated) vaccine within 4 weeks prior to baseline.

         10. History of alcohol or drug abuse that would interfere with the subject's ability to
             comply with protocol requirements.

         11. Treatment with any investigational drug within 3 months of screening visit.