Clinical trial NCT00554606: Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
Official title: A 54-week, Phase II, Multi-center, Open-label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1B Monoclonal Antibody) in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Anti-interleukin-1 beta
ACZ885
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-07
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients (male and non-pregnant, non-lactating females) who completed the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent

Exclusion Criteria:

* Patients for whom continued treatment in the extension is not considered appropriate by the treating physician.
* Patients who were non-compliant or who demonstrated a major protocol violation in the core study.
* Patients who did not complete / discontinued from the core study.
* Patients with drug related serious adverse events or severe adverse events.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: From start of the study up to End Of Study (Week 60)
Secondary outcomes:
measure: Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Change From Baseline in ACR Component : Swollen Joint Count Through Week 54
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Change From Baseline in ACR Component : Tender Joint Count Through Week 54
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Core Study Change From Baseline in Edema, Erosion and Synovitis Score Was Assessed at Week 18
timeFrame: Baseline, Week 18
measure: Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Erosion Score at Week 18
timeFrame: Baseline, Week 18
measure: Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Joint Narrowing Score at Week 18
timeFrame: Baseline, Week 18
measure: Core Study BMD of Total Lumbar Spine, Hip and Hand Was Assessed by DXA at Week 18
timeFrame: Baseline, Week 18
measure: Number of Subjects With Long-term Immunogenicity
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Pharmacokinetic (PK) of ACZ885: Systemic Clearance From Serum Following Intravenous Administration (CL) in Participants
timeFrame: Pre dose at Day 1, Pre dose at week 6, 12, 18, 24, 30, 36, 42, 48, follow up and at study completion (week 60)
measure: Pharmacokinetic (PK) of ACZ885: Volume Distribution From Serum Following Intravenous Administration (CL) in Participants
timeFrame: Pre dose at Day 1, Pre dose at week 6, 12, 18, 24, 30, 36, 42, 48, follow up and at study completion (week 60)
measure: Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Physical Component)
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score
timeFrame: Baseline Up to End Of Study (up to week 60)
measure: Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Mental Component)
timeFrame: Baseline Up to End Of Study (up to week 60)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Novartis Investigator Site
state: Alabama
city: Paradise Valley
country: United States
facility: Novartis Investigator Site
state: Arizona
city: Trumbull
country: United States
facility: Novartis Investigator Site
state: Connecticut
city: Jacksonville
country: United States
facility: Novartis Investigator Site
state: Florida
city: South Miami
country: United States
facility: Novartis Investigator Site
state: Florida
city: Tamarac
country: United States
facility: Novartis Investigator Site
state: Florida
city: Rockford
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Urbandale
country: United States
facility: Novartis Investigator Site
state: Indiana
city: Richmond Heights
country: United States
facility: Novartis Investigator Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigator Site
state: Nebraska
city: Reno
country: United States
facility: Novartis Investigator Site
state: Nevada
city: Tulsa
country: United States
facility: Novartis Investigator Site
state: Oklahoma
city: Austin
country: United States
facility: Novartis Investigator Site
state: Texas
city: Carrollton
country: United States
facility: Novartis Investigator Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigator Site
state: Texas
city: Fort Worth
country: United States
facility: Novartis Investigator Site
state: Texas
city: Mesquite
country: United States
facility: Novartis Investigator Site
state: Texas
city: Arlington
country: United States
facility: Novartis Investigator Site
state: Virginia
city: Spokane
country: United States
facility: Novartis Investigator Site
state: Washington
city: Antwerpen
country: Belgium
facility: Novartis Investigator Site
city: Diepenbeek
country: Belgium
facility: Novartis Investigator Site
city: Liege
country: Belgium
facility: Novartis Investigator Site
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Hamburg
country: Germany
facility: Novartis Investigator Site
city: Hannover
country: Germany
facility: Novartis Investigator Site
city: Ratingen
country: Germany
facility: Novartis Investigator Site
city: Sendenhorst
country: Germany
facility: Novartis Investigator Site
city: Wiesbaden
country: Germany
facility: Novartis Investigator Site
city: Arenzano
country: Italy
facility: Novartis Investigator Site
state: GE
city: Valeggio sul Mincio
country: Italy
facility: Novartis Investigator Site
state: VR
city: Genova
country: Italy
facility: Novartis Investigator Site
city: Padova
country: Italy
facility: Novartis Investigator Site
city: Leeuwarden
country: Netherlands
facility: Novartis Investigator Site
city: Leiden
country: Netherlands
facility: Novartis Investigator Site
city: Venlo
country: Netherlands
facility: Novartis Investigator Site
city: Moscow
country: Russian Federation
facility: Novartis Investigator Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigator Site
city: Yekaterinburg
country: Russian Federation
facility: Novartis Investigator Site
city: Alicante
country: Spain
facility: Novartis Investigator Site
city: Barcelona
country: Spain
facility: Novartis Investigator Site
city: Bilbao
country: Spain
facility: Novartis Investigator Site
city: Madrid
country: Spain
facility: Novartis Investigator Site
city: Santiago de Compostela
country: Spain
facility: Novartis Investigator Site
city: Sevilla
country: Spain
facility: Novartis Investigator Site
city: Valencia
country: Spain
facility: Novartis Investigator Site
city: Basel
country: Switzerland
facility: Novartis Investigator Site
city: Zurich
country: Switzerland
facility: Novartis Investigator Site
city: Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Izmir
country: Turkey
facility: Novartis Investigator Site
city: Sihhiye/Ankara
country: Turkey
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: NOVARTIS
role: PRINCIPAL_INVESTIGATOR
References: