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

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NCT02697773

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Study Location
Alabama Orthopaedic Surgeons
Birmingham, Alabama, 35235, United States
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Contact
877-355-2010
[email protected]
Related Links

FOR MORE INFORMATION

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis, Hip Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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 Details
Administration
The form in which the study drug will be delivered to the patient's body.
Subcutaneous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Trial Procedures
Physical examination
Vital signs and measurements
X-rays
Electrocardiogram (ECG)
Blood test
Keeping a diary
Questionnaire

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Osteoarthritis, Hip
Intervention  ICMJE
  • Other: Placebo
    Patient receives one dose of placebo to match tanezumab subcutaneously on Day 1 and one dose of placebo to match tanezumab subcutaneously at Week 8.
  • Biological: Tanezumab 2.5 mg
    Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 2.5 mg subcutaneously at Week 8.
  • Biological: Tanezumab 2.5mg/5mg
    Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.
    Other Name: Titration Arm
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    placebo administered subcutaneously at day 0 and week 8
    Intervention: Other: Placebo
  • Experimental: Tanezumab 2.5 mg
    tanezumab 2.5 mg administered subcutaneously at day 0 and week 8
    Intervention: Biological: Tanezumab 2.5 mg
  • Experimental: Tanezumab 2.5mg/5mg
    tanezumab 2.5 mg administered subcutaneously at day 0 and tanezumab 5 mg administered subcutaneously at week 8
    Intervention: Biological: Tanezumab 2.5mg/5mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2018)		698
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2016)		690
Actual Study Completion Date  ICMJE May 14, 2018
Actual Primary Completion Date December 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Puerto Rico,   United States
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT02697773
Other Study ID Numbers  ICMJE A4091056
2013-002222-23 ( EudraCT Number )
OA TITRATION STUDY ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP