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

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

Sponsors

Lead Sponsor: Pfizer

Collaborator: Eli Lilly and Company

Source Pfizer
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.

Overall Status Completed
Start Date August 23, 2016
Completion Date July 15, 2019
Primary Completion Date July 15, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Surgeon's Assessment of Procedural Difficulty Day 1
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Week 24
Number of Participants With Post-Surgical Complications Upto Week 24 Baseline up to Week 24
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 Baseline up to Week 24
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 Baseline up to Week 24
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 Baseline, Week 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 Baseline, Week 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 Baseline, Week 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 Baseline, Week 24
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 Baseline, Week 24
Number of Participants Who Used Concomitant Analgesic Medications Baseline up to Week 24
Enrollment 154
Condition
Intervention

Intervention Type: Drug

Intervention Name: Investigational Medical Product (IMP) administered in parent study

Description: IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.

Arm Group Label: Cohort 1

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
Facility:
Central Alabama Research | Birmingham, Alabama, 35209, United States
Alabama Clinical Therapeutics, LLC | Birmingham, Alabama, 35235, United States
Alabama Orthopaedic Surgeons | Birmingham, Alabama, 35235, United States
Cahaba Research Inc. | Birmingham, Alabama, 35242, United States
Noble Clinical Research | Tucson, Arizona, 85704, United States
Baptist Health Center for Clinical Research | Little Rock, Arkansas, 72205, United States
Advanced Research Center, Inc. | Anaheim, California, 92805, United States
Hope Clinical Research | Canoga Park, California, 91303, United States
Marvel Clinical Research, LLC | Huntington Beach, California, 92647, United States
Advances in Medicine | Palm Desert, California, 92260, United States
Clinical Trials Research | Sacramento, California, 95821, United States
California Research Foundation | San Diego, California, 92123, United States
CITrials | Santa Ana, California, 92705, United States
Stamford Therapeutics Consortium | Stamford, Connecticut, 06905, United States
JEM Research Institute | Atlantis, Florida, 33462, United States
Orthopedic Research Institute | Boynton Beach, Florida, 33472, United States
Orthopaedic Associates of West Florida | Clearwater, Florida, 33756, United States
Clinical Neuroscience Solutions, Inc. | Jacksonville, Florida, 32256, United States
Clintex Research Group | Miami, Florida, 33135, United States
Renstar Medical Research | Ocala, Florida, 34470, United States
American Family Medical | Ocala, Florida, 34471, United States
Sunshine Research Center | Opa-locka, Florida, 33054, United States
Gulfcoast Research Institute, LLC | Sarasota, Florida, 34232-6028, United States
Kennedy White Orthopaedic Center | Sarasota, Florida, 34232, United States
Stedman Clinical Trials | Tampa, Florida, 33613, United States
Masters of Clinical Research, Inc. | Augusta, Georgia, 30909, United States
North Georgia Clinical Research | Woodstock, Georgia, 30189, United States
North Georgia Internal Medicine | Woodstock, Georgia, 30189, United States
Injury Care Research | Boise, Idaho, 83713, United States
Chicago Clinical Research Institute, Inc. | Chicago, Illinois, 60607, United States
Northwestern University | Chicago, Illinois, 60611, United States
Professional Research Network of Kansas, LLC | Wichita, Kansas, 67205-1138, United States
Best Clinical Trials, LLC | New Orleans, Louisiana, 70115, United States
George Stanley Walker, MD | New Orleans, Louisiana, 70115, United States
Great Lakes Research Group, Incorporated | Bay City, Michigan, 48706, United States
Orthopaedic Associates of Michigan, PC | Grand Rapids, Michigan, 49525, United States
Physician Research Collaboration, LLC | Lincoln, Nebraska, 68516, United States
Drug Trials America | Hartsdale, New York, 10530, United States
Remington-Davis, Incorporated | Columbus, Ohio, 43215, United States
Optimed Research LTD | Columbus, Ohio, 43235, United States
AC Clinical Research | Tiffin, Ohio, 44883, United States
Founders Research Corporation | Philadelphia, Pennsylvania, 19114, United States
Abigail R. Neiman, MD, PA | Houston, Texas, 77024, United States
Advances In Health | Houston, Texas, 77030, United States
Mercury Clinical Research, Inc. | Houston, Texas, 77036, United States
BI Research Center | Houston, Texas, 77084, United States
ClinRx Research | Richardson, Texas, 75080, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials | San Antonio, Texas, 78258, United States
Mercury Clinical Research | Webster, Texas, 77598, United States
Spectrum Medical, Inc. | Danville, Virginia, 24541, United States
Northwest Clinical Research Center | Bellevue, Washington, 98007, United States
CMAX Clinical Research Pty Ltd | Adelaide, South Australia, 5000, Australia
Dawson Road Medical Centre | Guelph, Ontario, N1H 1B1, Canada
Rebecca Medical Associates | Oakville, Ontario, L6K 1J6, Canada
Recherche Clinique Sigma inc | Quebec, G1G 3Y8, Canada
Centre de recherche Saint-Louis | Quebec, G1W 4R4, Canada
Rheumazentrum Prof. Dr. med Gunther Neeck | Bad Doberan, 18209, Germany
Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly | Szekszard, 7100, Hungary
Azienda Ospedaliero-Universitaria E Policlinico Umberto I | Rome, 00161, Italy
Omuro Orthopedic Clinic | Himeji, Hyogo, 670-0976, Japan
Nakajo Orthopedic Clinic | Sendai, Miyagi, 983-0862, Japan
Marunouchi Hospital | Matsumoto, Nagano, 390-8601, Japan
National Hospital Organization Osaka Minami Medical Center | Kawachinagano, Osaka, 586-8521, Japan
Osaka University Hospital | Suita, Osaka, 565-0871, Japan
Saules seimos medicinos centras | Kaunas, LT-49449, Lithuania
South Pacific Clinical Trials | Auckland, 0610, New Zealand
Star Unit, North Shore Hospital, Waitemata District Health Board | Auckland, 0622, New Zealand
Southern Clinical Trials- Waitemata Ltd | Auckland, 0626, New Zealand
Clinical Horizons NZ Ltd | Tauranga, 3112, New Zealand
Hospital Conde de Bertiandos | Ponte de Lima, Viana DO Castelo, 4990-041, Portugal
Medical Technologies Ltd. | Saint-Petersburg, 191025, Russian Federation
Institute of Rheumatology | Belgrade, 11000, Serbia
Kompan, s.r.o. | Dolny Kubin, 02601, Slovakia
Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o. | Pruske, 018 52, Slovakia
Instituto de Ciencias Medicas | Alicante, 03004, Spain
Hospital del Mar | Barcelona, 08003, Spain
Ladulaas Kliniska Studier | Boras, Sweden, SE-506 30, Sweden
ProbarE I Lund AB | Lund, 222 22, Sweden
ProbarE i Stockholm AB | Stockholm, 111 37, Sweden
Location Countries

Australia

Canada

Germany

Hungary

Italy

Japan

Lithuania

New Zealand

Portugal

Russian Federation

Serbia

Slovakia

Spain

Sweden

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Cohort 1

Type: Other

Description: long-term observational study of subjects from tanezumab parent study

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov