Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee
Status: | Completed |
---|---|
Conditions: | Arthritis, Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/4/2018 |
Start Date: | January 2016 |
End Date: | May 2018 |
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study Of The Analgesic Efficacy And Safety Of A Dose Titration Regimen For The Subcutaneous Administration Of Tanezumab In Subjects With Osteoarthritis Of The Hip Or Knee
The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab
in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg)
at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study
also evaluates the safety of the treatment regimens.
in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg)
at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study
also evaluates the safety of the treatment regimens.
Inclusion Criteria:
- Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray
- Documented history that subject tried the following medications and had insufficient
pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either
tramadol or opioids
- Meet the protocol requirements for pain at screening and pain, physical function and
patient global assessment of osteoarthritis at baseline
- Willing to discontinue all pain medications except study medication and rescue
medication during the course of the study and use those as directed per protocol
- Women able to have children must agree to use 2 forms of contraception during the
study
Exclusion Criteria:
- Body Mass Index (BMI) greater than 39
- History of diseases other than osteoarthritis in a shoulder, hip or knee (example,
rheumatoid arthritis, gout, joint infections, osteonecrosis)
- Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or
certain types of fractures
- Patients who have had significant trauma or surgery to a knee, hip or shoulder within
the previous year
- Planned surgical procedure during the study
- Patients who are largely or wholly incapacitated (example bedridden or confined to a
wheelchair, permitting little or no self-care)
- Patients who would be unwilling or unable to undergo joint replacement surgery if one
eventually became necessary
- Patients with significant conditions other than osteoarthritis that could interfere
with assessment of pain in the joints (example fibromyalgia, lupus erythematosus)
- Patients with significant heart, neurological or psychiatric diseases
- Patients who had cancer other than certain skin cancers within the past 5 years
- Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2
years
- Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed
during the course of the study.
We found this trial at
78
sites
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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