Long Term Safety Study of Tanezumab in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Tanezumab 20 mg; Tanezumab 10 mg
Intervention description: Tanezumab 20 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks; Tanezumab 10 mg administered IV every 8 weeks for 3 administrations followed by SC administration every 8 weeks for 4 administrations over a period of 64 weeks
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 849.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: low back pain monoclonal antibody nerve growth factor

Summary:

      The purpose of this study is to investigate the safety and efficacy of tanezumab for chronic
      low back pain. Patients who were randomized and treated with study medication in a previous
      chronic low back pain "parent" study will be eligible to enroll in this safety extension
      study at the Preferred Rollover Time Point visit or at the Early Termination visit of the
      parent study upon discontinuation due to lack of efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent prior to completing any of the study procedures.

          -  Female patients must meet one of the following criteria:

             1) Female patients of non childbearing potential - Must be post menopausal, defined as
             women who are >=45 years old with amenorrhea for 24 consecutive months (regardless of
             FSH levels), or women who are amenorrheic for at least 1 year AND have a serum
             Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the
             parent double blind CLBP study; or Must be surgically sterile, defined as having had a
             hysterectomy and/or bilateral oophorectomy.

             2.) Female patients of child bearing potential: must not be pregnant or lactating, and
             must be abstinent or use adequate contraception (2 forms of birth control, one of
             which must be a barrier method), and must have a negative serum pregnancy test at
             Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at
             Baseline prior to initial dosing

          -  Male patients must agree that they and their female spouses / partners will use
             adequate contraception (2 forms of birth control, one of which must be barrier method)
             or be of non childbearing potential.

          -  Females of child bearing potential and males must be willing to use approved methods
             of contraception from commencement of screening procedures until 16 weeks after the
             last dose of IV study medication.

          -  Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment
             plan, laboratory tests, and other study procedures

          -  Patient has been treated in a parent tanezumab double blind CLBP study

          -  Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP
             parent study or has been withdrawn for lack of efficacy. At least eight weeks but no
             more than 12 weeks have elapsed since the last study medication infusion in the parent
             study. Patients are permitted to enter the extension study up to 12 weeks after their
             last dose of study medication in their parent study (or 4 weeks after the End of
             Treatment visit)

        Exclusion Criteria:

          -  Failed screening in a parent tanezumab double blind CLBP study

          -  Withdrawn from a parent tanezumab double blind CLBP study for an adverse event

          -  Pregnant women, lactating mothers, women suspected of being pregnant, and women who
             wish to become pregnant during the course of clinical study

          -  Use of any investigational medication within 30 days prior to Baseline (3 months for
             any investigational biological other than tanezumab) or plans to receive an
             investigational medication other than the study medication during the course of this
             study

          -  Patients who exited the parent double blind CLBP study because of lack of compliance,
             protocol violation (including not meeting entrance criteria), no longer willing to
             participate (for reasons other than lack of efficacy), or were lost to follow up in
             the parent double blind study

          -  Patients who were randomized into the parent study in violation of inclusion or
             exclusion criteria but who were not withdrawn from the parent study;

          -  Any other condition, which in the opinion of the Investigator, would put the patient
             at increased safety risk or otherwise make the patient unsuitable for this study