A Study of Tanezumab in Adults With Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

A RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, ACTIVE- AND PLACEBO-CONTROLLED, MULTI-CENTER, PARALLEL GROUP STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876187
• Other study ID #: A4091012
• Secondary ID: CLBP-IV PH2B
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2009
• Est. completion date: February 1, 2011

Study information

• Verified date: June 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of multiple doses of tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a monoclonal antibody directed against human nerve growth factor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1359
• Est. completion date: February 1, 2011
• Est. primary completion date: June 16, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Present with duration of low back pain of =3 months requiring regular use of analgesic medication (>4 days per week for the past month). Analgesic medication may consist of NSAIDs, selective COX-2 inhibitors, immediate release opioids, or combinations, with certain protocol-defined limitations.

• Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh

• Must meet criteria for pain severity and global assessment of low back pain at Screening and Baseline visits

• Female patients of child-bearing potential (and male patients with female partners who are of child-bearing potential) must use 2 methods of contraception throughout the study

• Patients must be willing to discontinue all pain medications for chronic low back pain except rescue medication and not use prohibited pain medications throughout the duration of the study

Exclusion Criteria:

• History of lumbosacral radiculopathy within the past 2 years.

• Back pain due to visceral disorder (eg, endometriosis).

• Back pain due to major trauma or osteoporotic compression fracture in the past 6 months.

• History of rheumatoid arthritis, seronegative spondyloarthropathy, Paget's disease of spine, pelvis or femur; fibromyalgia; tumors or infections of the spinal cord.

• Surgical intervention during the past 6 months for the treatment of low back pain or plans for surgical intervention during the course of the study.

• Current or pending worker's compensation, litigation, disability, or any other monetary settlement regarding his/her CLBP or any other pain condition, or any closed claim within the past 5 years.

• Use of any analgesic or muscle relaxant within 48 hours prior to the five days before Baseline

• Patients receiving only acetaminophen, gabapentin or pregabalin to manage their chronic low back pain.

• Patients taking >325 mg/day of aspirin.

• Use of any antidepressants with the exception of stable treatment with selective serotonin reuptake inhibitors (SSRIs).

• Use of any sedatives/hypnotics, anxiolytics, tranquilizers, or benzodiazepines unless daily dose has been stable and will remain unchanged throughout the study period.

• Systemic corticosteroid therapy within 30 days (inhaled and topical corticosteroids are permitted).

• Local or epidural injection of corticosteroids, as well as injections of corticosteroids in the back within 3 months.

• Botulinum toxin (Botox®) injection for chronic low back pain within 4 months.

• Requirement for new, concomitant physiotherapy including, but not limited to, transdermal electroneural stimulation (TENS), massage or spinal manipulation for the duration of the study period.

• Active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration within 3 months, or any history of gastrointestinal bleeding.

• Current use of lithium or anticoagulant agents.

• Known hypersensitivity or intolerance to NSAIDs; history of asthma, urticaria, or allergic type reactions after taking aspirin or NSAIDs.

• Inflammatory bowel disease, a chronic or acute renal or hepatic disorder, a significant coagulation defect, or other condition that might preclude the use of an NSAID.

• History of intolerance to acetaminophen or paracetamol or any of its excipients.

• History of known alcohol, analgesic or narcotic abuse within 2 years.

• Presence of drugs of abuse (including prescription medications without a valid prescription), other illegal drugs or marijuana in the urine toxicology screen obtained at Screening.

• History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein.

• Use of biologics other than study medication, including any live vaccines, within 3 months, or use during the study (intranasal Flumist® vaccine is an exception).

• Signs and symptoms of clinically significant cardiac disease.

• Diagnosis of a transient ischemic attack within the 6 months, or residual deficits from stroke that would preclude completion of required study activities.

• History of cancer within 5 years.

• Use of any investigational medication within 30 days (3 months for investigational biologics).

• Expected to undergo a therapeutic procedure or to use any analgesic other than those specified in the protocol throughout the study period.

• Previous exposure to exogenous NGF or to an anti NGF antibody.

• Screening laboratory results and blood pressure within specified limits.

• Positive Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) tests at screening.

• History, diagnosis, or signs and symptoms of clinically significant neurological disease.

• History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder.

• Hospital admission for depression or suicide attempt within 5 years or active, severe major depression at Screening.

• Likelihood of being non compliant with study procedures.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Biological:
• Tanezumab 20 mg IV
2 IV administrations of tanezumab 20 mg at an 8 week interval

Drug:
• Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks

Biological:
• Tanezumab 10 mg IV
2 IV administrations of tanezumab 10 mg at an 8 week interval

Drug:
• Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks

Biological:
• Tanezumab 5 mg IV
2 IV administrations of tanezumab 5 mg at an 8 week interval

Drug:
• Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks

Biological:
• Placebo for tanezumab
2 IV administrations of placebo for tanezumab at an 8 week interval

Drug:
• Naproxen
Oral naproxen 500 mg twice a day for 16 weeks

Biological:
• Placebo for tanezumab
2 IV administrations of placebo for tanezumab at an 8 week interval

Drug:
• Placebo for naproxen
Oral placebo for naproxen twice a day for 16 weeks

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Allegheny Pain Management	Altoona	Pennsylvania
United States	Pinnacle Research Group LLC	Anniston	Alabama
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Center for Prospective Outcome Studies	Atlanta	Georgia
United States	Capitol Medical Clinic	Austin	Texas
United States	FutureSearch Trials	Austin	Texas
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Walter F. Chase, MD, PA	Austin	Texas
United States	Peter A. Holt, MD	Baltimore	Maryland
United States	DiscoveResearch, Inc.	Beaumont	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	East Penn Rheumatology Associates, PC	Bethlehem	Pennsylvania
United States	The Center for Clinical Trials	Biloxi	Mississippi
United States	Simon Williamson Clinic, PC	Birmingham	Alabama
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	Selah Medical Center, PA	Boise	Idaho
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Paramount Clinical Research	Bridgeville	Pennsylvania
United States	DiscoveResearch, Incorporated	Bryan	Texas
United States	Providence Clinical Research	Burbank	California
United States	Trinity Hypertension & Metabolic Research Institute Punzi Medical Center	Carrollton	Texas
United States	Radiant Research - Phoenix Southeast	Chandler	Arizona
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Southeast Clinical Research	Chiefland	Florida
United States	Southeast Clinical Research, LLC	Chiefland	Florida
United States	Community Research	Cincinnati	Ohio
United States	Sterling Research	Cincinnati	Ohio
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	Clinicos, LLC	Colorado Springs	Colorado
United States	Columbia Arthritis Center, P.A.	Columbia	South Carolina
United States	Southern Orthopaedic Sports Medicine	Columbia	South Carolina
United States	New England Center for Clinical Research	Cranston	Rhode Island
United States	KRK Medical Research	Dallas	Texas
United States	Doctors Medical Center of Walton County	DeFuniak Springs	Florida
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	SJS Clinical Research, Inc.	Destin	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	CRIA Research	Fort Lauderdale	Florida
United States	Valley Research	Fresno	California
United States	Collaborative Neuroscience Network, Inc	Garden Grove	California
United States	SCRI Research Center	Germantown	Tennessee
United States	Wolf River Medical Group, LLC	Germantown	Tennessee
United States	Pharmquest	Greensboro	North Carolina
United States	Radiant Research	Greer	South Carolina
United States	Advances In Health, Inc.	Houston	Texas
United States	Centex Research	Houston	Texas
United States	Centex Research, Inc.	Houston	Texas
United States	Simon-Williamson Clinic, PC	Hueytown	Alabama
United States	Saadat Ansari, MD office	Huntsville	Alabama
United States	Clinical Research Center of Jackson	Jackson	Mississippi
United States	Physician's Surgery Center	Jackson	Mississippi
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Southeast Clinical Research, LLC	Jacksonville	Florida
United States	Advanced Therapeutics, Inc.	Johnson City	Tennessee
United States	Johnson City Internal Medicine	Johnson City	Tennessee
United States	University of California San Diego	La Jolla	California
United States	PCM Medical Services	Lansing	Michigan
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	Mirkil Medical	Las Vegas	Nevada
United States	Northstate Clinical Research, PLLC	Lenoir	North Carolina
United States	Central Kentucky Research Association, Inc.	Lexington	Kentucky
United States	Little Rock Family Practice Clinic	Little Rock	Arkansas
United States	Samaritan Center for Medical Research Medical Group	Los Gatos	California
United States	Commonwealth Biomedical Research, LLC	Madisonville	Kentucky
United States	Central New York Clinical Research	Manlius	New York
United States	Drug Studies America	Marietta	Georgia
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	Horizon Research Group	Mobile	Alabama
United States	Arthritis and Diabetes Clinic	Monroe	Louisiana
United States	Collier Neurologic Specialists	Naples	Florida
United States	Centex Research	Nassau Bay	Texas
United States	Medex Healthcare Research	New York	New York
United States	Medex Healthcare Research, Inc.	New York	New York
United States	The Medical Research Network, LLC	New York	New York
United States	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia
United States	North County Clinical Research (NCCR)	Oceanside	California
United States	Christine Codding, MD	Oklahoma City	Oklahoma
United States	Health Research of Oklahoma	Oklahoma City	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	McBride Clinic	Oklahoma City	Oklahoma
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Compass Research, LLC	Orlando	Florida
United States	Vince and Associates Clinical Research	Overiand Park	Kansas
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	University Clinical Research Incorporated	Pembroke Pines	Florida
United States	Pivotal Research Centers	Peoria	Arizona
United States	CRI Worldwide LLC	Philadelphia	Pennsylvania
United States	Arizona Research Center	Phoenix	Arizona
United States	Advent Clinical Research Center	Pinellas Park	Florida
United States	Summit Research Network (Oregon), Inc.	Portland	Oregon
United States	Clinical Trials Technology, Inc.	Prairie Village	Kansas
United States	Wake Internal Medicine Consultants, Inc.	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Advances in Medicine	Rancho Mirage	California
United States	Health Concepts	Rapid City	South Dakota
United States	National Clinical Research, Incorporated	Richmond	Virginia
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Rochester Clinical Research	Rochester	New York
United States	Quality Control Research, Inc	Roseville	California
United States	Center for Clinical Trials of Sacramento, Inc.	Sacramento	California
United States	Medex Healthcare Research, Inc.	Saint Louis	Missouri
United States	Mercy Health Research	Saint Louis	Missouri
United States	Dale G. Bramlet, MD	Saint Petersburg	Florida
United States	Meridien Research	Saint Petersburg	Florida
United States	Foothill Family Clinic	Salt Lake City	Utah
United States	Foothill Family Clinic	Salt Lake City	Utah
United States	Office of Theresia Lee, MD	San Antonio	Texas
United States	Paragon Research Center	San Antonio	Texas
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Wetlin Research Associates, Inc	San Diego	California
United States	Radiant Research, Inc.: Scottsdale, AZ	Scottsdale	Arizona
United States	Arthntis & Rheumatic Care Center	South Miami	Florida
United States	Miami Research Associates	South Miami	Florida
United States	Clinvest/ A Division of Banyan Group, Inc.	Springfield	Missouri
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Clinical Research Advantage, Inc./Fiel Family and Sports Medicine, PC	Tempe	Arizona
United States	Premiere Phamaceutical Research, LLC	Tempe	Arizona
United States	Cotton-O'Neil Clinical Research	Topeka	Kansas
United States	New England Research Associates, LLC	Trumbull	Connecticut
United States	Alta Clinical Research, LLC	Tucson	Arizona
United States	Inland Rheumatology & Osteoporosis Medical Group, Inc.	Upland	California
United States	Advanced Pain Management	Virginia Beach	Virginia
United States	Omega Medical Research	Warwick	Rhode Island
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Elite Clinical Trials	Wildomar	California
United States	Upstate Clinical Research Associates	Williamsville	New York
United States	CRI Worldwide	Willingboro	New Jersey
United States	The Center for Clinical Research	Winston-Salem	North Carolina
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF)	Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity.	Baseline, Week 16
Secondary	Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	RMDQ: back-specific, participant administered questionnaire that assesses how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement if it describes his/her functional ability on the day of assessment. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements marked. Total possible RMDQ score: 0 (best functioning) to 24 (worst functioning), with higher scores indicated greater disability.	Baseline, Week 2, 4, 8, 12, 16
Secondary	Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range:1 to 5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).	Baseline, Week 2, 4, 8, 12, 16
Secondary	Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit.	Baseline, Week 2, 4, 8, 12
Secondary	Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF)	Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Participants with specified reduction (as percent) from baseline at Week 16 are reported.	Baseline, Week 16
Secondary	Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit.	Baseline, Week 2, 4, 8, 12, 16
Secondary	Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF)	BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain, each with a score range: 0 (no pain) and 10 (pain as bad as you can imagine), higher scores indicated worse pain.	Baseline, Week 2, 4, 8, 12, 16
Secondary	Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF	BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure pain interference (PI) on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes); higher score = greater impairment. The 7 items in Q5 averaged to obtain pain interference index (function composite score), range: 0 (no interference) to 10 (complete interference); higher score = greater impairment.	Baseline, Week 2, 4, 8, 12, 16
Secondary	Time to Discontinuation Due to Lack of Efficacy	Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.	Baseline up to Week 16
Secondary	Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF)	Chronic Low Back Pain (CLBP) Responder Index: A response was defined as reduction of at least 30% in mean daily average LBPI from baseline to a specified week, decrease of at least 30% in PGA of low back pain from baseline to the specified week and no worsening (increase) in RMDQ total score from baseline to the specified week. Participants who were responders were reported.	Week 2, 4, 8, 12, 16
Secondary	Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16	WPAI:SHP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Four scores are derived as percent: activity impairment (AI), impairment while working (IW), overall work impairment (OWI), work time missed (WTM). Each of 4 scores expressed as impairment percentages with a total possible score range of 0 to 100, high percentage= more impairment, less productivity.	Baseline, Week 8, 16
Secondary	Percentage of Participants Who Used Rescue Medications	In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.	Week 2, 4, 8, 12, 16
Secondary	Duration of Rescue Medication Use	In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.	Week 2, 4, 8, 12, 16
Secondary	Amount of Rescue Medication Taken	In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication.	Week 2, 4, 8, 12, 16
Secondary	Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24	NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.	Baseline, Week 8, 16, 24
Secondary	Number of Participants Who Developed Anti-Tanezumab Antibodies	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.	Baseline (Day 1), Week 8, 16, 24
Secondary	Plasma Concentration of Tanezumab	Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero.	Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit
Secondary	Total Nerve Growth Factor (NGF) Concentration		Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the 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 drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.	Baseline up to Week 24

External Links

•   To obtain contact information for a study center near you, click here.