None listed
Conditions
Interventions
Tanezumab Type of group
10 mg of tanezumab, administered as an IV infusion on Day 1, Day 57 (Week 8), Day 113 (Week 16), and Day 169 (Week 24).
Sponsors
PFIZER S.A.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • The patient must give written consent to participate in the study, signing and dating an informed consent document indicating that the patient has been informed of all relevant aspects of the study, before any procedure related to the study is performed. . • The patient who meets the eligibility criteria to, and be randomized and treated intravenously with Study drug A4091003. • At least 8 weeks, but not more than 16, must have elapsed since the intravenous infusion of the study drug of A4091003. • Female patients must meet one of the following criteria: a) Female patients without pregnancy potential: they must be post menopausal, defined as women who are> 45 years of age, amenorrheic for more than 24 consecutive months (regardless of levels of FSH in Study Selection A4091003), or women who are amenorrheic for at least 1 year AND have a serum follicle stimulating hormone (FSH) level, which is greater than 30 lU / L in the Selection of Study A4091003; or have been surgically sterilized, this is defined as having performed a hysterectomy and / or a bilateral oophorectomy. b) Female patients with potential for pregnancy: they must not be pregnant or breastfeeding and must practice withdrawal or use appropriate contraceptive methods (2 forms of contraceptive control, one of which must be a barrier method) from the Baseline visit until 16 weeks later of the last dose of the study medication. Women with pregnancy potential must have a negative result in the serum pregnancy test at the Study End Visit A4091003, or a negative result in the urine pregnancy test at the Baseline, before the initial dosage. • Patients must have obtained a Karnofsky Performance score> 40% at Baseline; • The patient has a life expectancy> 6 months at the Baseline; • The patient must desire and be able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: • The patient was removed from Study A4091003 because of an adverse event or a serious adverse event. • Use of any investigational medication within 30 days prior to Baseline, or plans to receive an investigational medication other than the study medication, during the course of this study. • Patients who were suspended in Study A4091003 before Week 8 due to lack of compliance with the treatment, violation of the protocol, failure to meet the inclusion criteria, revocation of consent, disease progression, or patients who were lost during the follow-up they will be excluded from the Study • Appearance of any adverse event or condition, during Study A4091003 or since the termination of that study, which in the opinion of the investigator, would put the patient at an increased safety risk, or that would exclude him from participating in the open extension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The BPI Total score is calculated as the average of the seven interference reagents (questions 5a - g), in the BPI-sf questionnaire. In the event that one of the seven reactants is missing, then the average rating of the remaining reagents is used to impute the missing value (the seventh). In the event that more than one reagent is missing, the total rating will be omitted. Measure:Change from Baseline to Weeks 4, 8, 16, 24 and 40, in the pain ratings of the Brief Pain Questionnaire (BPI) Timepoints:Weeks 4, 8, 16, 24 and 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The BPI Total score is calculated as the average of the seven interference reagents (questions 5a - g), in the BPI-sf questionnaire. In the event that one of the seven reactants is missing, then the average rating of the remaining reagents is used to impute the missing value (the seventh). In the event that more than one reagent is missing, the total rating will be omitted. Measure:Change from Baseline to Weeks 4, 8, 16, 24 and 40, in BPI Pain interference, with the Total Performance Rating and the qualifications of the pain interference reagents in particular, which were obtained in the visits of the study. Timepoints:Weeks 4, 8, 16, 24 and 40 ; Outcome name:Each adverse event will be counted once according to the start date. Measure:Safety analysis Timepoints:During the study ; Outcome name:The Kamofsky Performance Scale is an 11-point scale (rated from 100 to 0) with the highest numbers indicating a better performance status. Measure:Variation in the Karnofsky Performance Scale Timepoints:The Kamofsky Performance Scale will be applied by the staff of the study site, on Visit 1 and 7 / or in the Early Termination. | — |
Countries
Austria, Bosnial and Herzegovina, Croatia, France, Hungary, India, Korea South, Latovia, Peru, Poland, Slovakia, United States
Contacts
Public ContactMaria Elena Echelin
PFIZER S.A.
Outcome results
None listed