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

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2013-002549-12-ES
• Date of registration: 31/07/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
• Public title: PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
• Scientific title: PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
• Date of first enrolment: 07/08/2015
• Target sample size: 211
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002549-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: long-term observational study of subjects enrolled in A4091056, A4091057 or A4091058; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Brazil, Bulgaria, Colombia, Croatia, Finland, Germany, Hungary, Italy, Japan, Korea, Republic of, Lithuania, Mexico, New Zealand, Peru, Philippines, Poland, Portugal, Russian Federation, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: ClinicalTrials.gov call Center
• Affiliation: Pfizer Inc

• Name: ClinicalTrials.gov call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Subject has been randomized and treated with SC investigational product in tanezumab Study A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063 and has completed the study or has been withdrawn from the study.
3. Actual or planned total knee, hip or shoulder replacement surgery during tanezumab Study A4091056, A4091057 or A4091058 or after the last subject in the study completes the treatment period in tanezumab Study A4091059, A4091061 or A4091063.
4. Subject is willing and able to comply with scheduled visits and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 137
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion criteria:
Not reported in protocol


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Osteoarthritis of the hip or knee
MedDRA version: 18.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
MedDRA version: 18.0 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859

Intervention(s)

Product Name: Tanezumab
Product Code: PF-04383119
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tanezumab
CAS Number: 880266-57-9
Current Sponsor code: PF-04383119
Other descriptive name: RI624, RN624
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: Tanezumab
Product Code: PF-04383119
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tanezumab
CAS Number: 880266-57-9
Current Sponsor code: PF-04383119
Other descriptive name: RI624, RN624
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: Celecoxib
Pharmaceutical Form: Capsule
INN or Proposed INN: Celecoxib
CAS Number: 169590-42-5
Other descriptive name: Celecoxib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use

Product Name: Naproxen
Pharmaceutical Form: Tablet
INN or Proposed INN: Naproxen
CAS Number: 22204-53-1
Other descriptive name: Naproxen
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Diclofenac
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: Diclofenac
CAS Number: 15307-86-5
Other descriptive name: Diclofenac
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0-
Pharmaceutical form of the placebo: Modified-release capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: -To compare the post-operative outcome for tanezumab 2.5 mg and 5 mg versus NSAID for subjects who underwent a total knee, hip, or shoulder replacement while participating in tanezumab Study A4091058.

-To describe the post-operative outcome of subjects from the A4091059, A4091061 or A4091063 studies who underwent a total knee, hip, or shoulder replacement.

Main Objective: To describe the post-operative outcome of subjects who underwent a total knee, hip,or shoulder replacement while participating in tanezumab Study A4091056, A4091057 or A4091058 (treatment period and safety follow-up period).

Timepoint(s) of evaluation of this end point: Please refer to the protocol

Primary end point(s): -Surgeon?s Assessment of Procedural Difficulty: number and percentage of surgeries assessed as uneventful, minor complications or major complications.
-Subject?s overall satisfaction with surgery as assessed by the Self-Administered Patient Satisfaction (SAPS) Scale: number and percentage of subjects satisfied vs. unsatisfied with their total joint replacement at Week 24.
-Number and percentage of subjects with a post-surgical complication(s) up to Week 24 (derived from reported adverse events).
- Number and percentage of subjects with additional or corrective procedures related to their total joint replacement up to Week 24.
- Number and percentage of subjects participating in physical rehabilitation activities related to the replaced joint up to Week 24.
-Change from Baseline to Week 24 in average pain in the replaced joint.
-Change from Baseline to Week 24 in WOMAC Pain, Stiffness and Physical Function subscales in the replaced joint (subjects undergoing total hip or knee replacement surgery only).
-Change from Baseline to Week 24 in the SPADI in the replaced shoulder (subjects undergoing total shoulder replacement surgery only).
-Concomitant analgesic medication use.

Secondary Outcome(s)

Secondary end point(s): not applicable

Timepoint(s) of evaluation of this end point: not applicable

Secondary ID(s)

2013-002549-12-HU

A4091064

Source(s) of Monetary Support

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

Ethics review

Status: Approved
Approval date:
Contact: