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Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain (TANGO)

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ClinicalTrials.gov Identifier: NCT02725411
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5 mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7 administrations).

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Celecoxib Biological: Tanezumab 5 mg Biological: Tanezumab 10 mg Drug: Placebo for celecoxib Biological: Placebo for tanezumab Phase 3

Detailed Description:
This is a randomized, double-blind, active-controlled, multicenter, parallel-group Phase 3 study of the safety and efficacy of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio. Treatment groups will include: 1) Placebo SC matching tanezumab administered at an 8-week interval (total of 7 times) plus celecoxib 100 mg twice a day (BID) to be administered orally for 56 weeks; 2) Tanezumab 5 mg SC administered at an 8-week interval (total of 7 times) plus placebo matching celecoxib to be administered orally BID for 56 weeks; 3) Tanezumab 10 mg SC administered at an 8-week interval (total of 7 times) plus placebo matching celecoxib to be administered orally BID for 56 weeks. The study is designed with a total duration (post-randomization) of up to 80 weeks and will consist of three periods: Screening (up to 37 days; includes a Washout Period and an Initial Pain Assessment Period [IPAP]), a Double-blind Treatment Period (56 weeks) and a Follow-up Period (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 to 32 days), if required, and an IPAP (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must be experiencing some benefit (eg, analgesic effect) from their current stable dose regimen of oral NSAID (celecoxib, loxoprofen or meloxicam) treatment, be tolerating their NSAID regimen, be taking this medication regularly (defined as an average of at least 5 days per week) during the 30 day period prior to the Screening Visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN JAPANESE ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
Actual Study Start Date : May 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
Drug Information available for: Celecoxib

Arm Intervention/treatment
Active Comparator: Celecoxib
Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral celecoxib 100 mg twice daily for 56 weeks
Drug: Celecoxib
Orally administered Celecoxib 100 mg twice daily for 56 weeks

Biological: Placebo for tanezumab
Subcutaneous injection of the placebo every 8 weeks for 56 weeks

Experimental: Tanezumab 5 mg
Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for celecoxib twice daily for 56 weeks
Biological: Tanezumab 5 mg
Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks

Drug: Placebo for celecoxib
Orally administered the placebo twice daily for 56 weeks

Experimental: Tanezumab 10 mg
Subcutaneous injection of tanezumab 10 mg every 8 weeks plus oral placebo for celecoxib twice daily for 56 weeks
Biological: Tanezumab 10 mg
Subcutaneous injection of tanezumab 10 mg every 8 weeks for 56 weeks

Drug: Placebo for celecoxib
Orally administered the placebo twice daily for 56 weeks




Primary Outcome Measures :
  1. Incidence of Subjects with Adverse Events [ Time Frame: Week 80 ]
  2. Incidence of Subjects with Clinical Laboratory Test Abnormalities [ Time Frame: Week 64 ]
    Hematology and blood chemistry values

  3. Change from Baseline Sitting Blood Pressure [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 ]
  4. Change from Baseline Sitting Heart Rate [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 ]
  5. Change from Baseline Orthostatic (supine/standing) Blood Pressure [ Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 ]
  6. Change from baseline Survey of Autonomic Symptom scores [ Time Frame: Screening and Weeks 24, 56 and 80 ]
  7. Change from Baseline 12-lead Electrocardiogram [ Time Frame: Weeks 16, 56 and 80 ]
  8. Incidence of individual adjudication outcomes [ Time Frame: 80 Weeks ]
    Adjudication outcomes specified in protocol

  9. Incidence of all cause total joint replacements [ Time Frame: 80 weeks ]
    All cause total joint replacement is as defined in the protocol

  10. Change from baseline Neurologic examinations [ Time Frame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 ]
    Neuropathy Impairment Score [NIS]

  11. Change from baseline Anti-tanezumab antibody levels [ Time Frame: Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80 ]
  12. Change from baseline Incidence of Physical Examination Findings [ Time Frame: Screening and Week 56 ]

Secondary Outcome Measures :
  1. Change from Baseline in average Low Back Pain Intensity (LBPI) score [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 ]
  2. Change from Baseline in the Roland Morris Disability Questionnaire (RMDQ) total score [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  3. Change from Baseline in Patient's Global Assessment of Low Back Pain [ Time Frame: Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 ]
  4. Cumulative distribution of percent change from Baseline in average LBPI score [ Time Frame: Weeks 16, 24 and 56 ]
  5. Pain intensity Response [ Time Frame: Weeks 16, 24, 40 and 56 ]
    Response as defined by a ≥30%, ≥50%, ≥70% and a ≥90% reduction from Baseline in weekly average LBPI score derived from the subject diary at Weeks 16, 24, 40 and 56

  6. Change from Baseline in the Brief Pain Inventory-short form (BPI-sf) scores [ Time Frame: Weeks 2, 4, 8, 16, 24, 40, 56 and 64 ]
  7. Chronic Low Back Pain Responder Index [ Time Frame: Weeks 16, 24, 40 and 56 ]
  8. Patient's Global Assessment of Low Back Pain Treatment Response [ Time Frame: Weeks 16, 24, 40 and 56 ]
  9. Euro Quality of Life Health State Profile (EQ-5D-5L) [ Time Frame: Weeks 16 and 56 ]
  10. Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP) [ Time Frame: Weeks 16, 56 and 64 ]
    WPAI:LBP change from Baseline to Week 16, 56 and 64, in the percent work time missed due to chronic low back pain, percent impairment while working due to chronic low back pain, percent overall work impairment due to chronic low back pain, and percent activity impairment due to chronic low back pain

  11. Incidence of discontinuation due to lack of efficacy [ Time Frame: Up to Week 56 ]
  12. Time to discontinuation due to lack of efficacy [ Time Frame: Up to Week 56 ]
  13. Incidence of rescue medication use [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 ]
  14. Number of days of rescue medication use [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 ]
  15. Amount of rescue medication taken [ Time Frame: Weeks 2, 4, 8, 12 and 16 ]
  16. Health Care Resource Utilization [ Time Frame: Baseline, Weeks 64 and 80 ]
  17. Treatment Satisfaction Questionnaire for Medication [ Time Frame: Weeks 16 and 56 ]
  18. Patient Reported Treatment Impact Assessment-Modified [ Time Frame: Weeks 16 and 56 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Duration of chronic low back pain for ≥3 months, and treatment with agents for low back pain for ≥3 months.
  • Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders.
  • Subjects must be experiencing some benefits from their current stable dose regimen of oral NSAID (celecoxib, loxoprofen or meloxicam) treatment as described in the protocol, be 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 low back pain, but still require additional pain relief at Screening.
  • Subjects must maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period.
  • Low Back Pain Intensity (LBPI) score of ≥5 at Screening.
  • Subjects must be willing to discontinue all pain medications for chronic low back pain except rescue medication and investigational product and not use prohibited pain medications throughout the duration of the study.
  • Female subjects of childbearing potential and at risk for pregnancy must agree to comply with protocol specified contraceptive requirements.

Exclusion Criteria:

  • Subjects exceeding protocol defined BMI limits.
  • Diagnosis of osteoarthritis of the knee or hip as defined by the ACR combined clinical and radiographic criteria.

    • Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip or Grade > or =3 radiographic evidence of knee osteoarthritis will be excluded.
    • Subjects who have Kellgren Lawrence Grade < or =2 radiographic evidence of knee osteoarthritis but who do not meet ACR criteria and do not have pain associated with their knee osteoarthritis will be allowed.
  • Subjects with symptoms and radiologic findings consistent with osteoarthritis in the shoulder.
  • History of lumbosacral radiculopathy within the past 2 years, history of spinal stenosis associated with neurological impairment, or history of neurogenic claudication.
  • Back pain due to recent major trauma within 6 months prior to Screening.
  • Surgical intervention during the past 6 months for the treatment of low back pain.
  • Planned surgical procedure during the duration of the study.
  • History or radiographic evidence of other diseases that could confound efficacy or safety assessments (eg, rheumatoid arthritis).
  • History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
  • History of osteonecrosis or osteoporotic fracture.
  • History of significant trauma or surgery to a knee, hip, or shoulder within the previous year.
  • Signs or symptoms of carpal tunnel syndrome in the one year prior to Screening.
  • Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required.
  • History of intolerance or hypersensitivity to celecoxib/acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of celecoxib/acetaminophen is contraindicated.
  • Use of prohibited medications or prohibited non-pharmacological treatments without the appropriate washout period (if applicable) prior to Screening or IPAP.
  • History of known alcohol, analgesic or narcotic abuse within 2 years of Screening.
  • Presence of drugs of abuse or illegal drugs in the urine toxicology screen obtained at Screening.
  • History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
  • Signs and symptoms of clinically significant cardiac disease.
  • Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening.
  • Evidence of protocol defined orthostatic hypotension at Screening.
  • Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening.
  • Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities.
  • History of cancer within 5 years prior to Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
  • Expected to undergo a therapeutic procedure or to use any analgesic other than those specified in the protocol throughout the pre-treatment and treatment periods that is likely to confound assessment of analgesic efficacy or safety.
  • Previous exposure to exogenous NGF or to an anti-NGF antibody.
  • Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits.
  • Positive Hepatitis B, Hepatitis C, or HIV tests at screening indicative of current infection.
  • History, diagnosis, or signs and symptoms of clinically significant neurological disease or clinically significant psychiatric disorder.
  • Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements.
  • Participation in other investigational drug studies within protocol defined time limits.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725411


  Show 55 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02725411     History of Changes
Other Study ID Numbers: A4091063
JAPAN CLBP SC STUDY ( Other Identifier: Alias Study Number )
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Chronic low back pain
Chronic pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Celecoxib
Tanezumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action