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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02674386
Other study ID # A4091064
Secondary ID 2013-002549-12TJ
Status Completed
Phase Phase 3
First received
Last updated
Start date August 23, 2016
Est. completion date July 15, 2019

Study information

Verified date July 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. The study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. There will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet).


Description:

A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date July 15, 2019
Est. primary completion date July 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Personally signed and dated informed consent document.

- Randomized and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.

- Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab study.

- Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

- None.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Investigational Medical Product (IMP) administered in parent study
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.

Locations

Country Name City State
Australia CMAX Clinical Research Pty Ltd Adelaide South Australia
Canada Dawson Road Medical Centre Guelph Ontario
Canada Rebecca Medical Associates Oakville Ontario
Canada Centre de recherche Saint-Louis Quebec
Canada Recherche Clinique Sigma inc Quebec
Germany Rheumazentrum Prof. Dr. med Gunther Neeck Bad Doberan
Hungary Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly Szekszard
Italy Azienda Ospedaliero-Universitaria E Policlinico Umberto I Rome
Japan Omuro Orthopedic Clinic Himeji Hyogo
Japan National Hospital Organization Osaka Minami Medical Center Kawachinagano Osaka
Japan Marunouchi Hospital Matsumoto Nagano
Japan Nakajo Orthopedic Clinic Sendai Miyagi
Japan Osaka University Hospital Suita Osaka
Lithuania Saules seimos medicinos centras Kaunas
New Zealand South Pacific Clinical Trials Auckland
New Zealand Southern Clinical Trials- Waitemata Ltd Auckland
New Zealand Star Unit, North Shore Hospital, Waitemata District Health Board Auckland
New Zealand Clinical Horizons NZ Ltd Tauranga
Portugal Hospital Conde de Bertiandos Ponte de Lima Viana DO Castelo
Russian Federation Medical Technologies Ltd. Saint-Petersburg
Serbia Institute of Rheumatology Belgrade
Slovakia Kompan, s.r.o. Dolny Kubin
Slovakia Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o. Pruske
Spain Instituto de Ciencias Medicas Alicante
Spain Hospital del Mar Barcelona
Sweden Ladulaas Kliniska Studier Boras, Sweden
Sweden ProbarE I Lund AB Lund
Sweden ProbarE i Stockholm AB Stockholm
United States Advanced Research Center, Inc. Anaheim California
United States JEM Research Institute Atlantis Florida
United States Masters of Clinical Research, Inc. Augusta Georgia
United States Great Lakes Research Group, Incorporated Bay City Michigan
United States Northwest Clinical Research Center Bellevue Washington
United States Alabama Clinical Therapeutics, LLC Birmingham Alabama
United States Alabama Orthopaedic Surgeons Birmingham Alabama
United States Cahaba Research Inc. Birmingham Alabama
United States Central Alabama Research Birmingham Alabama
United States Injury Care Research Boise Idaho
United States Orthopedic Research Institute Boynton Beach Florida
United States Hope Clinical Research Canoga Park California
United States Chicago Clinical Research Institute, Inc. Chicago Illinois
United States Northwestern University Chicago Illinois
United States Orthopaedic Associates of West Florida Clearwater Florida
United States Optimed Research LTD Columbus Ohio
United States Remington-Davis, Incorporated Columbus Ohio
United States Spectrum Medical, Inc. Danville Virginia
United States Orthopaedic Associates of Michigan, PC Grand Rapids Michigan
United States Drug Trials America Hartsdale New York
United States Abigail R. Neiman, MD, PA Houston Texas
United States Advances In Health Houston Texas
United States BI Research Center Houston Texas
United States Mercury Clinical Research, Inc. Houston Texas
United States Marvel Clinical Research, LLC Huntington Beach California
United States Clinical Neuroscience Solutions, Inc. Jacksonville Florida
United States Physician Research Collaboration, LLC Lincoln Nebraska
United States Baptist Health Center for Clinical Research Little Rock Arkansas
United States Clintex Research Group Miami Florida
United States Best Clinical Trials, LLC New Orleans Louisiana
United States George Stanley Walker, MD New Orleans Louisiana
United States American Family Medical Ocala Florida
United States Renstar Medical Research Ocala Florida
United States Sunshine Research Center Opa-locka Florida
United States Advances in Medicine Palm Desert California
United States Founders Research Corporation Philadelphia Pennsylvania
United States ClinRx Research Richardson Texas
United States Clinical Trials Research Sacramento California
United States DCT - Stone Oak, LLC dba Discovery Clinical Trials San Antonio Texas
United States California Research Foundation San Diego California
United States CITrials Santa Ana California
United States Gulfcoast Research Institute, LLC Sarasota Florida
United States Kennedy White Orthopaedic Center Sarasota Florida
United States Stamford Therapeutics Consortium Stamford Connecticut
United States Stedman Clinical Trials Tampa Florida
United States AC Clinical Research Tiffin Ohio
United States Noble Clinical Research Tucson Arizona
United States Mercury Clinical Research Webster Texas
United States Professional Research Network of Kansas, LLC Wichita Kansas
United States North Georgia Clinical Research Woodstock Georgia
United States North Georgia Internal Medicine Woodstock Georgia

Sponsors (2)

Lead Sponsor Collaborator
Pfizer Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Hungary,  Italy,  Japan,  Lithuania,  New Zealand,  Portugal,  Russian Federation,  Serbia,  Slovakia,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Surgeon's Assessment of Procedural Difficulty Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: "taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications." Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint. Day 1
Primary Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 SAPS contained four questions; How satisfied are you with the 1) results of your surgery 2) results of surgery for improving pain 3) results of surgery for improving ability to do home or yard work, and 4) results of surgery for improving your ability to do recreational activities. Items scored on a 4-point Likert scale with response of 'very satisfied' (100 points), 'somewhat satisfied' (75 points), 'somewhat dissatisfied' (50 points), and 'very dissatisfied' (25 points). The scale score calculated as mean of the scores of individual items, ranging from 25 to 100, with higher scores indicating greater satisfaction. Here, number of participants are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Participants may have been counted more than once if they had TJR surgery in more than one joint. Week 24
Primary Number of Participants With Post-Surgical Complications Upto Week 24 Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Participants may have been counted more than once if they had TJR surgery in more than one joint. Baseline up to Week 24
Primary Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 Participants were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Participants, who responded as yes have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint. Baseline up to Week 24
Primary Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 Participants responded with a yes or no to the following question ''are you participating in physical rehabilitation activities related to your replaced joint''. Participants responded with a yes, have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint. Baseline up to Week 24
Primary Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 Participants assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint. Baseline, Week 24
Primary Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint. Baseline, Week 24
Primary Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 WOMAC: self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the replaced/to be replaced index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint. Baseline, Week 24
Primary Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in replaced/ to be replaced index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Participants may have been counted more than once if they had TJR surgery in more than one joint. Baseline, Week 24
Primary Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 SPADI: self-administered questionnaire to measure pain and disability associated with shoulder pathology in participants with shoulder pain. It consists of two dimensions pain and function. Pain dimension:5 questions regarding severity of pain, scores ranged from 0=no pain to 10=worst pain imaginable, higher scores indicated extreme pain. Functional activities:8 questions to measure degree of difficulty with various activities of daily living that require upper extremity use, scores ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as the sum of non-missing scores divided by the maximum possible score (50 [for pain] and 80 [for disability]) multiplied by 100. A total score was calculated as the mean of two dimensions, ranged from 0=best to 100=worst, higher scores indicated worsening of condition. Baseline, Week 24
Primary Number of Participants Who Used Concomitant Analgesic Medications Baseline up to Week 24
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