Clinical trial NCT02674386: Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Official title: A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2016-02-04
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).

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

Eligibility criteria: 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and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.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.

Primary outcomes:
measure: Number of Participants With Surgeon's Assessment of Procedural Difficulty
timeFrame: Day 1
measure: Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24
timeFrame: Week 24
measure: Number of Participants With Post-Surgical Complications Upto Week 24
timeFrame: Baseline up to Week 24
measure: Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24
timeFrame: Baseline up to Week 24
measure: Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24
timeFrame: Baseline up to Week 24
measure: Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24
timeFrame: Baseline, Week 24
measure: Number of Participants Who Used Concomitant Analgesic Medications
timeFrame: Baseline up to Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Birmingham
country: United States
facility: Alabama Orthopaedic Surgeons
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Research Inc.
state: Alabama
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research, LLC
state: California
city: Palm Desert
country: United States
facility: Advances in Medicine
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Santa Ana
country: United States
facility: CITrials
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute
state: Florida
city: Clearwater
country: United States
facility: Orthopaedic Associates of West Florida
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: Clintex Research Group
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: American Family Medical
state: Florida
city: Opa-locka
country: United States
facility: Sunshine Research Center
state: Florida
city: Sarasota
country: United States
facility: Gulfcoast Research Institute, LLC
state: Florida
city: Sarasota
country: United States
facility: Kennedy White Orthopaedic Center
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Augusta
country: United States
facility: Masters of Clinical Research, Inc.
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Internal Medicine
state: Georgia
city: Boise
country: United States
facility: Injury Care Research
state: Idaho
city: Chicago
country: United States
facility: Chicago Clinical Research Institute, Inc.
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC
state: Louisiana
city: New Orleans
country: United States
facility: George Stanley Walker, MD
state: Louisiana
city: Bay City
country: United States
facility: Great Lakes Research Group, Incorporated
state: Michigan
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan, PC
state: Michigan
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Columbus
country: United States
facility: Remington-Davis, Incorporated
state: Ohio
city: Columbus
country: United States
facility: Optimed Research LTD
state: Ohio
city: Tiffin
country: United States
facility: AC Clinical Research
state: Ohio
city: Philadelphia
country: United States
facility: Founders Research Corporation
state: Pennsylvania
city: Houston
country: United States
facility: Abigail R. Neiman, MD, PA
state: Texas
city: Houston
country: United States
facility: Advances In Health
state: Texas
city: Houston
country: United States
facility: Mercury Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: BI Research Center
state: Texas
city: Richardson
country: United States
facility: ClinRx Research
state: Texas
city: San Antonio
country: United States
facility: DCT - Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
city: Webster
country: United States
facility: Mercury Clinical Research
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Adelaide
country: Australia
facility: CMAX Clinical Research Pty Ltd
state: South Australia
city: Guelph
country: Canada
facility: Dawson Road Medical Centre
state: Ontario
city: Oakville
country: Canada
facility: Rebecca Medical Associates
state: Ontario
city: Quebec
country: Canada
facility: Recherche Clinique Sigma inc
city: Quebec
country: Canada
facility: Centre de recherche Saint-Louis
city: Bad Doberan
country: Germany
facility: Rheumazentrum Prof. Dr. med Gunther Neeck
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria E Policlinico Umberto I
city: Himeji
country: Japan
facility: Omuro Orthopedic Clinic
state: Hyogo
city: Sendai
country: Japan
facility: Nakajo Orthopedic Clinic
state: Miyagi
city: Matsumoto
country: Japan
facility: Marunouchi Hospital
state: Nagano
city: Kawachinagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Kaunas
country: Lithuania
facility: Saules seimos medicinos centras
city: Auckland
country: New Zealand
facility: South Pacific Clinical Trials
city: Auckland
country: New Zealand
facility: Star Unit, North Shore Hospital, Waitemata District Health Board
city: Auckland
country: New Zealand
facility: Southern Clinical Trials- Waitemata Ltd
city: Tauranga
country: New Zealand
facility: Clinical Horizons NZ Ltd
city: Ponte de Lima
country: Portugal
facility: Hospital Conde de Bertiandos
state: Viana DO Castelo
city: Saint-Petersburg
country: Russian Federation
facility: Medical Technologies Ltd.
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Dolny Kubin
country: Slovakia
facility: Kompan, s.r.o.
city: Pruske
country: Slovakia
facility: Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o.
city: Alicante
country: Spain
facility: Instituto de Ciencias Medicas
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Boras, Sweden
country: Sweden
facility: Ladulaas Kliniska Studier
city: Lund
country: Sweden
facility: ProbarE I Lund AB
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Mont MA, Carrino JA, Nemeth MA, Burr A, Yamabe T, Viktrup L, Brown MT, West CR, Verburg KM. Postoperative Outcome of Patients Who Underwent Total Joint Replacement During the Tanezumab Phase 3 Osteoarthritis Development Program: A 24-Week Observational Study. Surg Technol Int. 2021 May 20;38:467-477. doi: 10.52198/21.STI.38.OS1439.