Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

Pfizer

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee

Treatments: Biological: Tanezumab 2.5mg/5mg; Other: Placebo; Biological: Tanezumab 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02697773

2013-002222-23 (EudraCT Number)

A4091056

OA TITRATION STUDY (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 698 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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698 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo administered subcutaneously at day 0 and week 8

Treatment:

Other: Placebo

Tanezumab 2.5 mg

Experimental group

Description:

tanezumab 2.5 mg administered subcutaneously at day 0 and week 8

Treatment:

Biological: Tanezumab 2.5 mg

Tanezumab 2.5mg/5mg

Experimental group

Description:

tanezumab 2.5 mg administered subcutaneously at day 0 and tanezumab 5 mg administered subcutaneously at week 8

Treatment:

Biological: Tanezumab 2.5mg/5mg