Phase 3
Completed N=1,825
A Phase 3 Study of Tanezumab for Chronic Low Back Pain
Source: ClinicalTrials.gov NCT02528253 ↗Enrolled (actual)
1,825
Serious AEs
4.9%
Results posted
Feb 2020
Primary outcomePrimary: Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 — -2.68; -2.98; -3.08; -2.81 units on a scale — p=0.1117
◆ Published Evidence
Established
57citations · ~10 / year
Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety.
Summary
This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
Linked Publications (2)
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Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety.
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Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 |
-2.68; -2.98; -3.08; -2.81 | 0.1117 |
| SECONDARY Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo |
-4.95; -6.27; -6.69; -5.21 | 0.0035 sig |
| SECONDARY Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 |
-2.68; -2.98; -3.08; -2.81 | 0.3118 |
| SECONDARY Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 |
-1.17; -1.54; -1.59; -1.36; -1.75; -2.24 | 0.0015 sig |
| SECONDARY Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 |
7.16; 7.23; 7.25; 7.18; 7.17; -4.36 | — |
| SECONDARY Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56 |
-2.46; -3.30; -3.84; -2.74; -3.37; -4.58 | 0.0121 sig |
| SECONDARY Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data |
14.64; 14.98; 15.02; 15.06; 15.10; -8.35 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 |
-0.54; -0.62; -0.67; -0.54; -0.64; -0.82 | 0.1472 |
| SECONDARY Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data |
3.47; 3.49; 3.47; 3.53; 3.50; -1.21 | — |
| SECONDARY Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF) |
80.8; 85.3; 87.2; 80.8; 73.6; 79.1 | — |
| SECONDARY Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF) |
20.8; 31.3; 31.8; 28.6; 8.9; 13.1 | 0.0007 sig |
| SECONDARY Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF) |
24.1; 32.3; 38.3; 29.3; 13.5; 20.0 | 0.0076 sig |
| SECONDARY Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56 |
71.2; 76.8; 83.5; 71.2; 68.2; 72.6 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 |
-1.17; -1.66; -1.76; -1.40; -1.73; -2.30 | 0.0003 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data |
7.93; 7.91; 7.95; 7.92; 7.92; -3.90 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data |
-0.93; -1.40; -1.47; -1.20; -1.52; -2.04 | 0.0002 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data |
6.87; 7.02; 7.00; 6.88; 6.97; -3.75 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data |
-1.40; -1.88; -1.97; -1.57; -1.90; -2.50 | 0.0013 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data |
5.85; 6.20; 6.28; 6.16; 6.21; -3.87 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data |
-1.46; -1.84; -1.91; -1.53; -1.92; -2.45 | 0.0137 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data |
6.40; 6.69; 6.69; 6.66; 6.67; -3.87 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data |
-1.28; -1.72; -1.89; -1.54; -1.81; -2.38 | 0.0059 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data |
5.66; 6.07; 5.95; 6.01; 6.04; -3.78 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data |
-1.58; -2.09; -2.15; -1.80; -2.13; -2.79 | 0.0037 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data |
6.45; 6.73; 6.88; 6.67; 6.82; -4.29 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data |
-1.30; -1.86; -2.01; -1.53; -1.92; -2.43 | 0.0007 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data |
6.31; 6.62; 6.65; 6.65; 6.56; -3.95 | — |
| SECONDARY Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 |
32; 62; 76; 74; 67; 115 | 0.0010 sig |
| SECONDARY Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF) |
9.4; 11.1; 14.7; 10.1; 13.8; 20.5 | 0.3260 |
| SECONDARY European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score |
2.5; 2.6; 2.5; 2.6; 2.6; 2.0 | — |
| SECONDARY European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value |
0.62; 0.61; 0.61; 0.62; 0.61; 0.74 | — |
| SECONDARY Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data |
8.2; 11.1; 10.8; 10.7; 57.9; 60.8 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64 |
-5.82; -5.07; -5.89; -5.68; -25.46; -29.49 | 0.6508 |
| SECONDARY Number of Participants Who Withdrew Due to Lack of Efficacy |
25; 41; 41; 46; 65 | 0.7366 |
| SECONDARY Time to Discontinuation Due to Lack of Efficacy |
NA; NA; NA; NA; NA | 0.4724 |
| SECONDARY Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64 |
226; 208; 318; 205; 175; 285 | 0.3960 |
| SECONDARY Number of Participants Who Took Rescue Medication During Week 64: Observed Data |
35; 26; 59; 70; 99 | — |
| SECONDARY Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 |
2.05; 1.85; 1.76; 1.62; 1.40; 1.46 | 0.1272 |
| SECONDARY Number of Days of Rescue Medication Used at Week 64 |
1.3; 1.3; 1.3; 1.4; 1.8 | — |
| SECONDARY Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16 |
2420.1; 2663.2; 2465.7; 2340.4; 2084.6; 1967.2 | 0.6764 |
| SECONDARY Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain |
1.0; 2.0; 2.0; 2.0; 2.0; 1.0 | — |
| SECONDARY Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain |
10; 14; 27; 17; 26; 4 | — |
| SECONDARY Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain |
1.0; 1.0; 1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain |
0; 0; 1; 0; 4; 0 | — |
| SECONDARY Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain |
9.0; 1.0; 1.0; 1.0; 3.0; 2.0 | — |
| SECONDARY Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things |
186; 190; 376; 371; 569; 2 | — |
| SECONDARY Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain |
17; 14; 28; 31; 47; 6 | — |
| SECONDARY Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain |
2.0; 2.0; 1.0; 3.8; 2.3; 1.1 | — |
| SECONDARY Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56 |
56.67; 63.69; 62.87; 61.39; 66.95; 79.26 | 0.0005 sig |
| SECONDARY Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling? |
20; 21; 22; 39; 213; 211 | — |
| SECONDARY Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment? |
150; 172; 191; 232; 57; 62 | — |
| SECONDARY Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain? |
167; 191; 210; 251; 61; 80 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
125; 319; 347; 421; 7; 21 | — |
| SECONDARY Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56 |
105; 119; 200; 1; 4; 1 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline |
16; 56; 61; 59 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline |
11; 40; 39; 45 | — |
| SECONDARY Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 |
122.3; 123.8; 122.6; 123.7; -1.3; -2.0 | — |
| SECONDARY Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 |
73.3; 73.1; 72.5; 73.2; 0.8; 0.5 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80 |
928.5; 911.4; 915.4; 918.9; 868.2; 897.1 | — |
| SECONDARY Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80 |
66.4; 67.4; 67.1; 66.9; 72.3; 68.3 | — |
| SECONDARY Number of Participants With Confirmed Orthostatic Hypotension |
0; 1; 0; 2; 1; 0 | — |
| SECONDARY Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 |
0.45; 0.43; 0.50; 0.48; 0.32; 0.28 | — |
| SECONDARY Percentage of Participants With Adjudicated Joint Safety Outcomes |
0; 1.0; 2.6; 0.2; 0; 1.0 | — |
| SECONDARY Percentage of Participants With Total Joint Replacements |
0; 0; 1.4; 0 | — |
| SECONDARY Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 |
1.00; 0.58; 0.86; 0.78; 0.02; 0.05 | — |
| SECONDARY Number of Participants With Anti Tanezumab Antibodies |
45; 38; 39; 68; 37; 32 | — |
Eligibility Criteria
Inclusion Criteria
-Chronic low back pain ≥3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.
Exclusion Criteria
--Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) 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;
- History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., 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.
- Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study
- History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol
- Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
Data sourced from ClinicalTrials.gov (NCT02528253) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.