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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02674386




Registration number
NCT02674386
Ethics application status
Date submitted
11/11/2015
Date registered
4/02/2016

Titles & IDs
Public title
Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Scientific title
A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
Secondary ID [1] 0 0
2013-002549-12
Secondary ID [2] 0 0
A4091064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Investigational Medical Product (IMP) administered in parent study

Other: Cohort 1 - long-term observational study of subjects from tanezumab parent study


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Surgeon's Assessment of Procedural Difficulty
Timepoint [1] 0 0
Day 1
Primary outcome [2] 0 0
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24
Timepoint [2] 0 0
Week 24
Primary outcome [3] 0 0
Number of Participants With Post-Surgical Complications Upto Week 24
Timepoint [3] 0 0
Baseline up to Week 24
Primary outcome [4] 0 0
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24
Timepoint [4] 0 0
Baseline up to Week 24
Primary outcome [5] 0 0
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24
Timepoint [5] 0 0
Baseline up to Week 24
Primary outcome [6] 0 0
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24
Timepoint [6] 0 0
Baseline, Week 24
Primary outcome [7] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
Timepoint [7] 0 0
Baseline, Week 24
Primary outcome [8] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24
Timepoint [8] 0 0
Baseline, Week 24
Primary outcome [9] 0 0
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
Timepoint [9] 0 0
Baseline, Week 24
Primary outcome [10] 0 0
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24
Timepoint [10] 0 0
Baseline, Week 24
Primary outcome [11] 0 0
Number of Participants Who Used Concomitant Analgesic Medications
Timepoint [11] 0 0
Baseline up to Week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/07/2019
Sample size
Target
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Germany
State/province [22] 0 0
Bad Doberan
Country [23] 0 0
Hungary
State/province [23] 0 0
Szekszard
Country [24] 0 0
Italy
State/province [24] 0 0
Rome
Country [25] 0 0
Japan
State/province [25] 0 0
Hyogo
Country [26] 0 0
Japan
State/province [26] 0 0
Miyagi
Country [27] 0 0
Japan
State/province [27] 0 0
Nagano
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Lithuania
State/province [29] 0 0
Kaunas
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland
Country [31] 0 0
New Zealand
State/province [31] 0 0
Tauranga
Country [32] 0 0
Portugal
State/province [32] 0 0
Viana DO Castelo
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Saint-Petersburg
Country [34] 0 0
Serbia
State/province [34] 0 0
Belgrade
Country [35] 0 0
Slovakia
State/province [35] 0 0
Dolny Kubin
Country [36] 0 0
Slovakia
State/province [36] 0 0
Pruske
Country [37] 0 0
Spain
State/province [37] 0 0
Alicante
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Sweden
State/province [39] 0 0
Boras, Sweden
Country [40] 0 0
Sweden
State/province [40] 0 0
Lund
Country [41] 0 0
Sweden
State/province [41] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02674386