Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED)
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Remicade
Intervention description: Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
Intervention MeSH terms: Infliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is an open-label, controlled sub-study to the parent protocol (P04041, NCT00779935) to
      examine the expression profile of genes in patients in the active stage of ankylosing
      spondylitis (AS) compared to the healthy population as control, moreover to examine the
      changes in expression profile during anti-tumor necrosis factor (TNF)-alpha treatment
      (Remicade).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ankylosing spondylitis proven by appropriate diagnostic methods
             (according to New York criteria).

          -  Refractory disease defined by failure of at least 2 non-steroidal anti-inflammatory
             drugs (NSAIDs) during a 3-month period and failure of sulfasalazine in subjects with
             associated peripheral arthritis.

          -  Active disease defined by:

               -  sustained bath ankylosing spondylitis disease activity index (BASDAI) of at least
                  40 on a 0-100 scale and

               -  expert opinion based on clinical features.

          -  Age between 18 and 70 years.

          -  Subjects using NSAIDs and/or sulfasalazine must have been on a stable dose for at
             least 4 weeks prior to study initiation, and may continue medication during the
             treatment period, but the dose must not be increased above the baseline.

          -  Subjects must be capable to demonstrate their willingness to participate in the study
             and comply with its procedures by signing a written informed consent.

          -  Men and women of childbearing potential (includes women who are less than 1 year
             postmenopausal and women who become sexually active) must be using an acceptable
             method of birth control (eg, hormonal contraceptive, medically prescribed intrauterine
             device (IUD), condom in combination with spermicide) or be surgically sterilized (eg,
             hysterectomy or tubal ligation).

          -  Subjects must understand and be able to adhere to the dosing and visit schedules.

        Exclusion Criteria:

          -  Subject with moderate or severe heart failure (New York Heart Association (NYHA) class
             III/IV).

          -  Remicade must not be given to subjects with a history of hypersensitivity to
             infliximab, to other murine proteins, or to any of the excipients.

          -  Subjects with pre-existing or recent onset of central nervous system demyelinating
             disorders.

          -  Age <18 or >70 years.

          -  Pregnant women, nursing mothers.

          -  Subjects who are incapacitated, largely or wholly bedridden or confined to a
             wheelchair, and who have little or no ability for self-care.

          -  Subjects who have any current systemic inflammatory condition with signs and symptoms
             that might confound the evaluations of benefit from infliximab therapy.

          -  Prior administration of infliximab or any other therapeutic agent targeted at reducing
             tumor necrosis factor (TNF) (eg, Etanercept, pentoxifylline, thalidomide or anti-CD4+
             antibody).

          -  Current treatment with systemic corticosteroid.

          -  Treatment with any investigational drug within the previous 3 months.

          -  History of known allergies to murine proteins.

          -  Subjects having active or inactive tuberculosis (TB). All subjects must be evaluated
             for both active and inactive ('latent') TB. This evaluation should include a detailed
             medical history with personal history of TB or possible previous contact with TB and
             previous and/or current immunosuppressive therapy. Appropriate screening tests (ie,
             tuberculin skin test and chest x-ray) should be performed in all subjects.

          -  Serious infection, such as sepsis, abscesses, hepatitis, pneumonia, pyelonephritis in
             the previous 3 months. Less serious infections in the previous 3 months, such as acute
             respiratory tract infection (colds) or uncomplicated urinary tract infection need not
             be considered exclusions at the discretion of the treating physician.

          -  History of opportunistic infections such as herpes zoster within 2 months of study
             initiation. Evidence of active cytomegalovirus (CMV), active pneumocystis carinii,
             drug resistant atypical mycobacterium, etc.

          -  Documented human immunodeficiency virus (HIV) infection.

          -  Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
             hematologic, endocrine, pulmonary, cardiac, neurological, or cerebral disease.

          -  Any currently known malignancy or pre-malignant lesions or any history of malignancy
             within the past 5 years (except non-melanoma skin cancer and surgically cured cervical
             cancer).

          -  Subjects with alcoholism, alcoholic liver disease, or other chronic liver disease.