Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Low Back Pain Osteoarthritis

Keywords

KneeHip

Outcome Measures

Primary Outcomes (1)

Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score
Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.
Week 1, Week 2, Week 4, Week 8, Week 12, Week 16

Secondary Outcomes (13)

Change From Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score
Week 2, Week 4, Week 8, Week 12, Week 16
Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
Week 2, Week 4, Week 8, Week 12, Week 16
Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score
Week 16
Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score
Week 2, Week 4, Week 8, Week 12, Week 16
Number of Adjudicated Arthropathy (AA) Events
Up to Week 36
+8 more secondary outcomes

Study Arms (2)

Fasinumab

EXPERIMENTAL

Subcutaneous (SC) every 4 weeks (Q4W)

Drug: Fasinumab

Placebo

EXPERIMENTAL

SC every 4 weeks

Drug: Placebo

Interventions

FasinumabDrug

Subcutaneous (SC) every 4 weeks (Q4W)

Also known as: REGN475

Fasinumab

PlaceboDrug

Subcutaneous (SC) every 4 weeks (Q4W)

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to screening visit)
Clinical diagnosis of OA in at least 1 hip or knee joint based on the American College of Rheumatology Criteria with radiographic evidence of OA (K-L ≥2) at screening

Sponsors & Collaborators

Teva Pharmaceutical Industries, Ltd.
Industrycollaborator
Regeneron Pharmaceuticals
Industrylead

Study Sites (56)

Regeneron Research Site

Phoenix, Arizona, 85053, United States

Regeneron Research Site

Tucson, Arizona, 85704, United States

Regeneron Research Site

Tucson, Arizona, 85712, United States

Regeneron Research Site

Anaheim, California, 92801, United States

Regeneron Research Site

Anaheim, California, 92805, United States

Regeneron Research Site

La Mesa, California, 91942, United States

Regeneron Research Site

North Hollywood, California, 91606, United States

MeSH Terms

Conditions

Osteoarthritis

Interventions

fasinumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

Enrollment and study drug administration was stopped due to an urgent safety measure. As a result the small number of participants enrolled in this study limited the interpretability of the efficacy results.

Results Point of Contact

Title: Study Director
Organization: Regeneron Pharmaceuticals, Inc.

Study Officials

Clinical Trial Management
Regeneron Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

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

Enrollment

63 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

October 30, 2017

Actual (reported)

Study Stopped

Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Fasinumab

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (56)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Study Stopped

Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Fasinumab

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (56)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations