Extension Study Of Tanezumab In Osteoarthritis

Phase 3TerminatedNCT00809783

Pfizer2,147 enrolled

Overview

Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

This study was terminated on 27 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,147

Conditions

Osteoarthritis

Interventions

tanezumabBIOLOGICAL

Tanezumab 10 mg

tanezumabBIOLOGICAL

Tanezumab 5 mg

tanezumabBIOLOGICAL

Tanezumab 2.5 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis Exclusion Criteria: * Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator

Locations (226)

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)

AE:any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE:an AE resulting in any of following outcomes or deemed significant for any other reason:death;initial or prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent or significant disability/incapacity;congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.

Time frame: A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)

Number of Participants With Abnormal Laboratory Findings

Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(\<)0.8\*lower limit of normal(LLN),MCV,MCH,MCHC\<0.9\*LLN or \>1.1\*ULN,platelet:\<0.5\*LLN or \>1.75\*upper limit of normal(ULN),white blood cell(WBC):\<0.6\*LLN or \>1.5\*ULN,lymphocyte,neutrophil,total neutrophil:\<0.8\*LLN or\>1.2\*ULN,basophil,eosinophil,monocyte:\>1.2\*ULN;total,direct bilirubin\>1.5\*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:\> 3.0\*ULN,total protein,albumin:\<0.8\*LLN or \>1.2\*ULN;blood urea nitrogen,creatinine:\>1.3\*ULN,uric acid\>1.2\*ULN;cholesterol,triglycerides\>1.3\*ULN;sodium \<0.95\*LLN or \>1.05\*ULN,potassium,chloride,calcium,magnesium,bicarbonate:\<0.9\*LLN or \>1.1\*ULN,phosphate\<0.8\*LLN or\>1.2\*ULN;glucose \<0.6\*LLN or \>1.5\*ULN,glycosylated Hgb \>1.3\*ULN,creatine kinase\>2.0\*ULN;urine(specific gravity \<1.003or\>1.030,pH \<4.5or\>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals\>=1,RBC,WBC \>1.5\*ULN,epithelial cell\>=6,casts,hyaline cast\>1,bacteria\>20).

Time frame: A4091016: Day 1 up to Week 80

Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings

Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.

Data from ClinicalTrials.gov

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Secondary Outcomes

Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72

NIS constitutes sum of 37 standard items of neuromuscular examination used to assess muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) scored on a scale: 0 (normal) to 4 (paralysis), with higher score=more weakness; components of reflexes and sensation (13 items) scored on a scale: 0= normal, 1= decreased or 2= absent. Total NIS score range 0 (no impairment) to 244 (maximum impairment), higher score = more impairment. Parent study baseline value calculated as average of pre-dose measurements of participants from study A4091011, A4091014, A4091015 and A4091018.

Time frame: Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72

Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab

Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.

Time frame: A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)

Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings

Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat and thyroid. Clinically significant changes were judged by investigator.

Time frame: Baseline (Day 1) up to Week 80

Number of Participants With Clinically Significant Abnormality in Vital Signs

Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs were judged by investigator and reported as adverse events were presented.

Time frame: A4091016: Baseline (Day 1) up to Week 80

Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.