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Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee (ALBATROSS-3)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fasitibant- low dose
Fasitibant- intermediate dose
Fasitibant- high dose
Placebo comparator
Sponsored by
Menarini Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee, Arthritis, WOMAC, Injections, intra-articular, Fasitibant, MEN 16132

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
  • Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
  • Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs

Exclusion Criteria:

  • History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
  • Any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study
  • Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
  • Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
  • Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
  • Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
  • Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
  • Patients with any clinically relevant or unstable disease, or malignant neoplasms that, in the opinion of the Investigator, may pose the patient at risk, or confound the efficacy and safety results of the study
  • Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
  • Pregnant and breastfeeding women
  • Any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
  • Patients with bleeding diathesis or on therapy with anticoagulants

Sites / Locations

  • Tucson Orthopaedic Institute
  • Colorado Orthopaedic Consultants
  • Avail Clinical Research, LLC
  • Radiant Research
  • Columbus Clinical Research
  • Blair Orthopaedic Associates
  • Tekton Research
  • Physicians Research Options, LLC
  • Spokan Joint Replacement Center
  • Revmatologie s.r.o.
  • Institute of Rheumatology, Charles University Faculty Hospital
  • MEDICAL PLUS s.r.o
  • Synexus Clinical Research GmbH, Research Centre Berlin
  • Synexus Clinical Research GmbH, Research Centre Bochum
  • Synexus Clinical Research GmbH, Research Centre Frankfurt
  • Clinical Research Hamburg GmbH
  • Synexus Clinical Research GmbH, Research Centre Leipzig
  • AmBeNet GmbH
  • Dipartimento di Medicina Interna - SOD di Reumatologia Azienda - Ospedaliero Universitaria Careggi
  • Azienda Ospedaliero-Universitaria S.Anna/ Unità Operativa Complessa e Sezione di Reumatologia/Dipartimento di Medicina Clinica e Sperimentale
  • Ospedale Galateo U.O. di Reumatologia
  • Ospedale Fornaroli/Unità Complessa di Reumatologia
  • Ospedale Luigi Sacco, Azienda Ospedaliera, Polo Universitario/Unità Operativa Complessa di Reumatologia
  • Azienda Ospedaliera di Perugia/Policlinico di Monteluce/Unità Operativa diagnosi e cura delle malattie reumatiche
  • Centro Ricerche Cliniche di Verona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Fasitibant low dose

Fasitibant intermediate dose

Fasitibant high dose

PLACEBO

Arm Description

Drug: solution for intra-articular injection

Drug: solution for intra-articular injection

Drug: solution for intra-articular injection

Drug: solution for intra-articular injection

Outcomes

Primary Outcome Measures

Change in WOMAC A
The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain.

Secondary Outcome Measures

Change in WOMAC INDEX
The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden.
Responder Rate According to OMERACT-OARSI Criteria
Percentage of responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria (OMERACT-OARSI criteria). Patients with at least 50 % improvement in pain or in function scores are considered responders. Alternatively, patients are considered responders if they show at least 20% improvement in at least two of the following scores: pain, function and Patients's Global Assessment (PGA) scores.
Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate
Response based on change ≥ 20 % from baseline for EQ-5D-5L index value

Full Information

First Posted
July 14, 2014
Last Updated
October 2, 2015
Sponsor
Menarini Group
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1. Study Identification

Unique Protocol Identification Number
NCT02205814
Brief Title
Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
Acronym
ALBATROSS-3
Official Title
A Double-blind, Randomised, Placebo-controlled, Four Parallel Arm, Dose-finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Intra-articular Injections of Fasitibant in Patients With Symptomatic Osteoarthritis of the Knee.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with symptomatic osteoarthritis (OA) of the knee. Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a total of 4 treatment arms. Each arm includes a single intra-articular injection of one of three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation ratio will be 1:1:1:1. The primary efficacy variable will be the change of the Western Ontario and McMaster Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and clinical laboratory tests; local tolerability at the injection site will also be assessed. In addition, the population pharmacokinetics and the exposure-response relationship will be evaluated. The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7 planned visits at site, including screening, randomisation, 4 follow-up visits and the End of study visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Knee, Arthritis, WOMAC, Injections, intra-articular, Fasitibant, MEN 16132

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fasitibant low dose
Arm Type
Experimental
Arm Description
Drug: solution for intra-articular injection
Arm Title
Fasitibant intermediate dose
Arm Type
Experimental
Arm Description
Drug: solution for intra-articular injection
Arm Title
Fasitibant high dose
Arm Type
Experimental
Arm Description
Drug: solution for intra-articular injection
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Drug: solution for intra-articular injection
Intervention Type
Drug
Intervention Name(s)
Fasitibant- low dose
Intervention Description
Single intra-articular injection of low dose of fasitibant
Intervention Type
Drug
Intervention Name(s)
Fasitibant- intermediate dose
Intervention Description
Single intra-articular injection of intermediate dose of fasitibant
Intervention Type
Drug
Intervention Name(s)
Fasitibant- high dose
Intervention Description
Single intra-articular injection of high dose of fasitibant
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
Single intra-articular injection of placebo
Primary Outcome Measure Information:
Title
Change in WOMAC A
Description
The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain.
Time Frame
from baseline up to 2 weeks after randomisation
Secondary Outcome Measure Information:
Title
Change in WOMAC INDEX
Description
The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden.
Time Frame
from baseline up to 6 weeks after randomisation
Title
Responder Rate According to OMERACT-OARSI Criteria
Description
Percentage of responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria (OMERACT-OARSI criteria). Patients with at least 50 % improvement in pain or in function scores are considered responders. Alternatively, patients are considered responders if they show at least 20% improvement in at least two of the following scores: pain, function and Patients's Global Assessment (PGA) scores.
Time Frame
from baseline up to 6 weeks after randomisation
Title
Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate
Description
Response based on change ≥ 20 % from baseline for EQ-5D-5L index value
Time Frame
from baseline up to 6 weeks after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged 40 to 80 years with BMI < 30 kg/m² Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs Exclusion Criteria: History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants Any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors Patients with any clinically relevant or unstable disease, or malignant neoplasms that, in the opinion of the Investigator, may pose the patient at risk, or confound the efficacy and safety results of the study Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters Pregnant and breastfeeding women Any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis Patients with bleeding diathesis or on therapy with anticoagulants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Pavelka, Professor
Organizational Affiliation
Institute of Rheumatology, Charles University Faculty Hospital, Na Slupi 4, 128 50 Prague 2, Czech Republic
Official's Role
Study Chair
Facility Information:
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Colorado Orthopaedic Consultants
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Avail Clinical Research, LLC
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Columbus Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Blair Orthopaedic Associates
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Physicians Research Options, LLC
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Spokan Joint Replacement Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Revmatologie s.r.o.
City
Brno
ZIP/Postal Code
638 00
Country
Czech Republic
Facility Name
Institute of Rheumatology, Charles University Faculty Hospital
City
Prague
ZIP/Postal Code
128 50
Country
Czech Republic
Facility Name
MEDICAL PLUS s.r.o
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czech Republic
Facility Name
Synexus Clinical Research GmbH, Research Centre Berlin
City
Berlin
ZIP/Postal Code
1262
Country
Germany
Facility Name
Synexus Clinical Research GmbH, Research Centre Bochum
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Synexus Clinical Research GmbH, Research Centre Frankfurt
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Clinical Research Hamburg GmbH
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Synexus Clinical Research GmbH, Research Centre Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
AmBeNet GmbH
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Dipartimento di Medicina Interna - SOD di Reumatologia Azienda - Ospedaliero Universitaria Careggi
City
Firenze
State/Province
Tuscany
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria S.Anna/ Unità Operativa Complessa e Sezione di Reumatologia/Dipartimento di Medicina Clinica e Sperimentale
City
Cona
ZIP/Postal Code
44124
Country
Italy
Facility Name
Ospedale Galateo U.O. di Reumatologia
City
Lecce
ZIP/Postal Code
73016
Country
Italy
Facility Name
Ospedale Fornaroli/Unità Complessa di Reumatologia
City
Magenta
ZIP/Postal Code
20013
Country
Italy
Facility Name
Ospedale Luigi Sacco, Azienda Ospedaliera, Polo Universitario/Unità Operativa Complessa di Reumatologia
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia/Policlinico di Monteluce/Unità Operativa diagnosi e cura delle malattie reumatiche
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
Centro Ricerche Cliniche di Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy

12. IPD Sharing Statement

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Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee

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