PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
- Conditions
- Osteoarthritis of the hip or kneeMedDRA version: 20.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859MedDRA version: 20.0Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-002549-12-AT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 211
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in tanezumab Study A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063 and has completed the study or has been withdrawn from the study.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
Not reported in protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method