A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections

NCT00994890 | Terminated Phase 2 Results DMC

• 2 other identifiers: A4091043SC OA SAFETY STUDY
• Study Type: interventional
• Target: 679
• Locations: 1 country
• Sites: 100

Brief Summary

This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Double-blind safety

Outcome Measures

Primary Outcomes (25)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or 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. 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 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

  Baseline up to 112 days after last dose of study medication (up to 345 days)

• Number of Participants With Laboratory Abnormalities

  Laboratory analysis included blood chemistry, hematology, urinalysis and pregnancy test.

  Baseline to Week 50

• Number of Participants With Abnormal Electrocardiogram (ECG) Findings

  All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula \[QTcF\], QT interval corrected for heart rate using Bazett's formula \[QTcB\], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as adverse events were presented.

  Baseline up to Week 50

• Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2

  NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

  Baseline, Week 2

• Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4

  NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

  Baseline, Week 4

• Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8

  NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

  Baseline, Week 8

• Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16

  NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

  Baseline, Week 16

• Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24

  NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

  Baseline, Week 24

• Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32

  NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

  Baseline, Week 32

• Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40

  NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

  Baseline, Week 40

• Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48

  NIS: 74-item, assess cranial nerves, muscle weakness, reflexes, sensation; scored separately for left, right limbs (37 items for each). Cranial nerves included 5 items (3rd nerve, 6th nerve, facial weakness, palate weakness, tongue weakness), muscle weakness included 19 items (respiratory,neck flexion, shoulder abduction, elbow flexion, brachioradialis,elbow extension, wrist flexion,wrist extension,finger flexion,finger spread,thumb abduction,hip flexion,hip extension,knee flexion,knee extension,ankle dorsiflexors,ankle plantar flexors,toe extensors,toe flexors), each item scored on scale 0=normal to 4=paralysis, higher score=greater weakness. Reflexes included 5 items (quadriceps femoris, triceps surae, biceps brachii, triceps brachii, brachioradialis), sensation included 4 items each for great toe and index finger (touch pressure, pin prick, vibration, joint position), each item scored as 0=normal, 1=decreased, 2=absent. Total NIS score range 0-244, higher score=greater impairment.

  Baseline, Week 48

• Number of Participants With Clinically Significant Change From Baseline in Physical Findings

  Physical examination included examination of abdomen, ears, extremities, eyes, head, heart, lungs, lymph nodes, neck, nose, skin, throat, thyroid, muscoskeletal, neurological and peripheral vascular system.

  Baseline to Week 50

• Number of Participants With Anti-Drug Antibody (ADA) at Day 1

  Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).

  Day 1

• Number of Participants With Anti-Drug Antibody (ADA) at Week 8

  Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.

  Week 8

• Number of Participants With Anti-Drug Antibody (ADA) at Week 24

  Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.

  Week 24

• Number of Participants With Anti-Drug Antibody (ADA) at Week 50

  Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative ELISA.

  Week 50

• Number of Participants With Vital Sign Abnormalities

  Examination of vital signs included body temperature, systolic blood pressure, diastolic blood pressure, pulse rate and respiratory rate. Participants with abnormal vital sign findings reported as adverse events were presented.

  Baseline up to Week 50

• Number of Participants With Injection-Site Reactions at Day 1

  Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

  Day 1

• Number of Participants With Injection-Site Reactions at Week 2

  Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

  Week 2

• Number of Participants With Injection-Site Reactions at Week 4

  Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

  Week 4

• Number of Participants With Injection-Site Reactions at Week 8

  Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

  Week 8

• Number of Participants With Injection-Site Reactions at Week 16

  Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

  Week 16

• Number of Participants With Injection-Site Reactions at Week 24

  Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

  Week 24

• Number of Participants With Injection-Site Reactions at Week 32

  Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

  Week 32

• Number of Participants With Injection-Site Reactions at Week 40

  Assessment of the injection-site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

  Week 40

Secondary Outcomes (15)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56

  Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56

  Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56

• Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56

  Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56

• Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response

  Week 2, 4, 8, 16, 24, 32, 40, 48, 56

• Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

  Week 2, 4, 8, 16, 24, 32, 40, 48, 56

Other Outcomes (1)

• Number of Participants With Subcutaneous Doses of Study Medication

  Day 1 up to Week 24

Study Arms (3)

Tanezumab 2.5 mg

EXPERIMENTAL

Drug: Tanezumab 2.5 mg

Tanezumab 5 mg

EXPERIMENTAL

Drug: Tanezumab 5 mg

Tanezumab 10 mg

EXPERIMENTAL

Drug: Tanezumab 10 mg

Interventions

Tanezumab 2.5 mg DRUG

Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year

Also known as: Biological

Tanezumab 2.5 mg

Tanezumab 5 mg DRUG

Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year

Also known as: Biological

Tanezumab 5 mg

Tanezumab 10 mg DRUG

Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year

Also known as: Biological

Tanezumab 10 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);

You may not qualify if:

• Body mass index (BMI) of \>39 kg/m2;
• Pregnancy or intent to become pregnant
• Planned surgical procedure during the duration of the study
• History of clinically significant cardiovascular, central nervous system or psychiatric disease
• Previous exposure to exogenous NGF or to an anti NGF antibody;
• Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions

Sponsors & Collaborators

• Pfizer: lead

Study Sites (100)

Mobile Diagnostic Center

Mobile, Alabama, 36608, United States

Location

Seton Medical Management, Inc.

Mobile, Alabama, 36608, United States

Location

Phoenix Rheumatology Specialists, Ltd.

Phoenix, Arizona, 85006, United States

Location

Radiant Research, Inc

Scottsdale, Arizona, 85251, United States

Location

Advanced Arthritis Care and Research

Scottsdale, Arizona, 85258, United States

Location

Catalina Pointe Clinical Research, Inc

Tucson, Arizona, 85704, United States

Location

Ft. Smith Rheumatology, PC

Fort Smith, Arkansas, 72903, United States

Location

Larry Watkins, MD

Little Rock, Arkansas, 72205, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72205, United States

Location

OrthoArkansas, PA

Little Rock, Arkansas, 72205, United States

Location

Radiology Consultants

Little Rock, Arkansas, 72205, United States

Location

Medvin Clinical Research

Covina, California, 91723, United States

Location

Pacific Arthritis Care Center

Los Angeles, California, 90045, United States

Location

Staywell Research

Northridge, California, 91325, United States

Location

University Imaging Centers

Northridge, California, 91325, United States

Location

C Michael Neuwelt, MD

San Leandro, California, 94578, United States

Location

Pacific Arthritis Center Medical Group

Santa Maria, California, 93454, United States

Location

Medvin Clinical Research

Whittier, California, 90606, United States

Location

RASF Clinical Research Center

Boca Raton, Florida, 33486, United States

Location

Sunrise Medical Research

Lauderdale Lake, Florida, 33319, United States

Location

Melbourne Internal Medicine Associates

Melbourne, Florida, 32901, United States

Location

MIMA Century Research Associate

Melbourne, Florida, 32901, United States

Location

Osler Medical, Inc.

Melbourne, Florida, 32901, United States

Location

Renstar Medical Research

Ocala, Florida, 344471, United States

Location

American Family Medical

Ocala, Florida, 34471, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Paddock Park Clinical Research

Ocala, Florida, 34474, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Pensacola Research Consultants, Inc.

Pensacola, Florida, 32504, United States

Location

Radiant Research, Inc

Pinellas Park, Florida, 33781, United States

Location

Jarred Frydman, DO

Plantation, Florida, 33324, United States

Location

Orthopaedic Center of South Flordia

Plantation, Florida, 33324, United States

Location

Advanced Medical Research

Port Orange, Florida, 32127, United States

Location

Center for Arthritis and Rheumatic Diseases

South Miami, Florida, 33143, United States

Location

Tampa Medical Group, P.A.

Tampa, Florida, 33614, United States

Location

Arthritis Center of North Georgia

Gainesville, Georgia, 30501, United States

Location

Radiant Research, Inc

Chicago, Illinois, 60654, United States

Location

Methodist Medical Group Rheumatology

Peoria, Illinois, 61602, United States

Location

Methodist Research Administration Office

Peoria, Illinois, 61602, United States

Location

Rockford Health Physicians

Rockford, Illinois, 61103-3692, United States

Location

Radiant Research, Inc

Overland Park, Kansas, 66202, United States

Location

Graves Gilbert Clinic

Bowling Green, Kentucky, 42101, United States

Location

Kentucky Medical Research Center

Lexington, Kentucky, 40504, United States

Location

Central Kentucky Research Associates

Mount Sterling, Kentucky, 40353, United States

Location

Mt. Sterling Clinic

Mount Sterling, Kentucky, 40353, United States

Location

Boston Clinical Trails, Inc.

Boston, Massachusetts, 02135, United States

Location

Woodrail Clinic

Columbia, Missouri, 65203, United States

Location

University Physicians

Columbia, Missouri, 65212, United States

Location

Kansas City Internal Medicine

Lee's Summit, Missouri, 64086, United States

Location

Clayton Medical Research

St Louis, Missouri, 63117, United States

Location

Advance Clinical Research Inc

St Louis, Missouri, 63128, United States

Location

St. Louis Center for Clinical Research

St Louis, Missouri, 63128, United States

Location

Barbara A. Caciolo

St Louis, Missouri, 63139, United States

Location

Montana Medical Research, Inc

Missoula, Montana, 59808, United States

Location

Internal Medical Associates of Grand Island, PC

Grand Island, Nebraska, 68803, United States

Location

Radiant Research, Inc

Las Vegas, Nevada, 89146, United States

Location

Buffalo Rheumatology

Orchard Park, New York, 14127, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Robert A. Harrell, MD

Durham, North Carolina, 27704, United States

Location

Piedmont Imaging

Winston-Salem, North Carolina, 27103, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Radiant Research, Inc

Columbus, Ohio, 43212, United States

Location

Clinical Research Source, Inc.

Perrysburg, Ohio, 43551, United States

Location

Bone Joint & Spine Surgeons, Inc.

Toledo, Ohio, 43623, United States

Location

McBride Clinic

Oklahoma City, Oklahoma, 73103, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Healthcare Research Consultants

Tulsa, Oklahoma, 74135, United States

Location

Integrated Medical Group PC/Fleetwood Clinical Research

Fleetwood, Pennsylvania, 19522, United States

Location

Research Across America @ Oyster Point Family Health Center

Lancaster, Pennsylvania, 17601, United States

Location

Arthritis Group

Philadelphia, Pennsylvania, 19152, United States

Location

Allegheny North Arthritis Center

Wexford, Pennsylvania, 15090, United States

Location

Jeffry A. Lindenbaum D.O., P.C.

Yardley, Pennsylvania, 19067, United States

Location

Anderson Radiology

Anderson, South Carolina, 29621, United States

Location

Primary Care Associates

Anderson, South Carolina, 29621, United States

Location

Radiant Research, Inc.

Anderson, South Carolina, 29621, United States

Location

Carolina Health Specialists

Myrtle Beach, South Carolina, 29572, United States

Location

Sarah Cannon Research Institute, LLC

Germantown, Tennessee, 38138, United States

Location

Wolf River Medical Group. LLC

Germantown, Tennessee, 38138, United States

Location

The Jackson Clinic, PA

Jackson, Tennessee, 38305, United States

Location

Office of John M. Joseph, M.D.

Carrollton, Texas, 75007, United States

Location

Arthritis Care and Diagnostic Center

Dallas, Texas, 75231, United States

Location

Houston Medical Research Associates

Houston, Texas, 77090, United States

Location

Nothwest Diagonstic Clinic, PA

Houston, Texas, 77090, United States

Location

Arthritis & Osteoporosis Center of South Texas

San Antonio, Texas, 78232, United States

Location

Texas Research Center, LP

Sugar Land, Texas, 77479, United States

Location

Trinity Clinic, Office of Research Administration

Tyler, Texas, 75701, United States

Location

Trinity Clinic, Rheumatology

Tyler, Texas, 75701, United States

Location

Physicians' Research Options, LLC

Draper, Utah, 84020, United States

Location

Lone Peak Family Medicine

Draper, Utah, 84070, United States

Location

Granger Medical Clinic

West Valley City, Utah, 84120, United States

Location

Arthritis and Rheumatic Disease Associates, PC

Burke, Virginia, 22015, United States

Location

Alan E. Schulman, MD

Richmond, Virginia, 23226, United States

Location

Steven Maestrello, M.D.

Richmond, Virginia, 23294, United States

Location

Richard Neiman, MD Inc.

Kirkland, Washington, 98034, United States

Location

South Puget Sound Clinical Research Center

Olympia, Washington, 98502, United States

Location

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, 25801, United States

Location

Aurora Advanced Healthcare

Milwaukee, Wisconsin, 53209, United States

Location

Arthritis Clinic

Racine, Wisconsin, 53406, United States

Location

Related Links

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

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

tanezumab; Biological Products

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Limitations and Caveats

Due to United States FDA imposed clinical hold, enrollment was stopped and study was terminated prematurely. Due to this, injection-site reaction data were not collected beyond Week 40 and NIS data were not collected beyond Week 48.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2009
• First Posted: October 14, 2009
• Study Start: November 17, 2009
• Primary Completion: December 7, 2010
• Study Completion: March 1, 2011
• Last Updated: May 13, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

US (100)