Safety Extension Study Of Tanezumab When Administered By Subcutaneous Injection To Patients With Osteoarthritis

NCT01127893 | Terminated Phase 3 Results DMC

• 2 other identifiers: A4091032SAFETY EXTENSION OF 1027
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks

Conditions

Osteoarthritis

Keywords

Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug, up to early termination (Day 107) that were absent before treatment in this study or that worsened relative to pretreatment state.

  Baseline up to Early Termination (Day 107)

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Laboratory examination included blood chemistry, hematology and urinalysis. Reported results were to include abnormal laboratory findings without regard to baseline abnormality.

  Baseline up to Early Termination (Day 107)

• Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

  Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), QT interval corrected using Fredericia's formula (QTcF), RR interval and heart rate (HR).

  Baseline up to Early Termination (Day 107)

• Number of Participants With Neurologic Examination Abnormalities

  Neurologic examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.

  Baseline up to Early Termination (Day 107)

• Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)

  Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).

  Baseline up to Early Termination (Day 107)

• Number of Participants With Injection Site Reactions

  Injection site reactions included: erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection has been administered.

  Baseline up to Early Termination (Day 107)

Secondary Outcomes (16)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64

  Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64

  Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64

• Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64

  Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64

• Percentage of Participants With Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Response

  Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64

• Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

  Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64

Study Arms (3)

Tanezumab 10 mg

EXPERIMENTAL

Biological: Tanezumab

Tanezumab 5 mg

EXPERIMENTAL

Biological: Tanezumab

Tanezumab 2.5 mg

EXPERIMENTAL

Biological: Tanezumab

Interventions

Tanezumab BIOLOGICAL

Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections

Tanezumab 10 mg

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have participated in specific Phase 3 parent study

You may not qualify if:

• Failed screening for parent study, pregnant women, lactating mothers

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Triwest Research Associates

La Mesa, California, 91942, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Osteoarthritis; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases

Interventions

tanezumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Due to the US FDA imposed clinical hold, enrollment and further dosing with study medication was stopped prematurely, only 1 participant was enrolled and the study was terminated early. Designation of outcomes as primary, secondary based on study team input as study did not specify them as primary or secondary.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: June 15, 2010
• Primary Completion: September 29, 2010
• Study Completion: September 29, 2010
• Last Updated: March 10, 2021
• Results First Posted: March 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)