Expired Study

Clinical Trial 4648

Oklahoma City, OK 73119

Study Summary:

This is a Study of the long-term analgesic efficacy and safety of tanezumab alone or in combination with non-steroidal anti-inflammatory drugs (nsaids) versus NSaids alone in patients with osteoarthritis of the knee or hip.

This study is of an investigational drug, Tanezumab. It is for people with Osteoarthritis of the knee or hip. There will be about 2,500 volunteers in this trial in about 300 sites.

Tanezumab is an antibody that attaches to human nerve growth factor (NGF). An antibody is a type of protein produced by the immune system that helps protect the body against foreign compounds.

If you choose to participate in this trial you will be given the study drug or a placebo along with other celecoxib (Celebrex) or naproxen (Aleve).

This study will last about 1 year and all doctors’ visits and medications will be provided at no charge. Compensation for your time and travel will be provided.

Qualified Participants Must:

• Have completed the IFC process and agreed to participate in the study
• Be 18 years of age or older
• Have confirmed diagnosis of OA of the knee of hip
• Be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen or Celecoxib, tolerating their NSAID regimen, be taking this medication regularly during the 30 day period prior to the screening visit and must have had some improvement in the OA joint pain, but still requiring additional pain relief Meet each of the following criteria:
• a. WOMAC Pain subscale NRS >=4 in index knee or hip at screening and baseline
• b. WOMAC Physical Function subscale NRS >=4 in index knee or hip at baseline
• c. Patient Global Assessment of Osteoarthritis must be: “fair”, “poor”, or “very poor” at baseline

• Be willing to discontinue all non-study pain medication of OA except rescue medication and not use prohibited pain medication throughout the duration of the study expect as permitted by the physician
• Female subjects of non-childbearing potential, surgically sterile
• Female subjects of childbearing potential, must agree to use 2 forms of contraceptives and must not be pregnant
• Be willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures
• Not be pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study
• Not have body mass index (BMI) of greater then 39 kg/m2
• Not have a history of other disease that may involve the index joint including inflammatory joint diseases, crystalline disease ( gout or pseudogout), endocrindopathies, metabolic joint diseases, lupus erythematosus, RA, joint infections. Neuropathic disorders, avascular necrosis, Paget’s disease or tumors
• Not have history of significant trauma or surgery to the index joint within the past year
• Have not planned surgery
• Not be largely or wholly incapacitated
• Not have fibromyalgia or other sever pain that may confound assessment or self –evaluation of pain associated with OA
• Not have history of cancer within the last 5 years
• Not have signs or symptoms of clinically significant cardiac disease, including but not limited to:
Heart attack in last 6 months
Surgery or stent in last 6 months
Congestive heart failure in last 6 months
Qtc interval>500 msec at screening or baseline
Resting tachycardia>120 or resting bradycardia<45 on ECG at screening or baseline
Stroke in last 6 months
• Have history or diagnosis of any of the following:
Peripheral neuropathy
Multiple sclerosis
Epilepsy or seizure
Psychotic disorders
Bipolar disorder
Somatoform disorders
Clinically significant head trauma in the last year
• Not have hospital admission for depression or suicide attempt within the last 5 years
• Not have presence of active severe major depression at screening (determined by a score of >15 on the PHQ-9)
• Not have history of drug or alcohol abuse within the last 2 years
• Not have previous exposure to exogenous NGF or to an anti-NGF antibody
• Not have history of allergic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein
• Have an intolerance to acetaminophen
• Have resting systolic>160mm or diastolic >100mm at screening. Subjects with previously diagnosed hypertension, antihypertensive medications must be stable for at least 30 days prior to screening
• Not have ALT or AST > 3X the upper limit, creatinine exceeding 1.7 in men or 1.5 in women or hemoglobin A1c > 10 at screening
• Not have presence of drug abuse(including prescription meds without a valid script), other illegal drugs or marijuana in the tox screen obtained at screening
• Not be positive for Hep B, C or HIV indicative of current or past infection
• Not have corticosteroids within the last 30 days prior to baseline
• Not have corticosteroids to the index joint within the last 12 weeks prior to baseline
• Not have intr-articular hyaluronic acid to the index joint within the last 30 days
• Not be on Warfarin or other Coumadin anticoagulant therapy within the last 30 days
• Not be on lithium within the last 30 days
• Not have a known hypersensitivity to NSAIDs or a history of asthma or allergic to Sulfa
• Not be taking aspirin > than 325mg/a day for non-analgesic or non-arthritic reasons at screening. Subjects taking<325mg/a day for non-analgesic or non-arthritic reasons at a stable dose for 30 days before baseline, will be allowed to continue their regimen for the duration of the study
• Not have active or suspected esophageal, gastric, pyloric or duodenal ulceration or bleeding within 90 days prior to baseline
• Not have Crohn’s disease, colitis, congestive cardiac failure
• Not use biologics, including live vaccines within 3 months of baseline
• Not use any investigational medication within the last 30 days
• Not have any condition, in the opinion of the investigator, which would put the subject at increased safety risk or otherwise make the patient unsuitable for this study

Qualified Participants May Receive:

$50 per completed visit up $1,500

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.