Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement

Osteoarthritis Clinical Trial

Official title:

A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674386
• Other study ID #: A4091064
• Secondary ID: 2013-002549-12TJ
• Status: Completed
• Phase: Phase 3
• 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
• 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and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.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.

Related Conditions & MeSH terms

• Osteoarthritis

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

External Links

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