Clinical trial NCT01443364: Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis
Official title: Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab pegol - Cimzia
Rheumatoid Arthritis
Power Doppler Ultrasonography
Italy
Moderate-severe Rheumatoid Arthritis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-09-29
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years
* positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)
* active RA disease
* subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).
* subject is naïve to RA related biologics

Exclusion Criteria:

* a diagnosis of any other inflammatory arthritis
* history of infected joint prosthesis, or other significant infection
* known Tuberculosis (TB) disease or high risk of acquiring TB infection

Primary outcomes:
measure: The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52
timeFrame: From Baseline to Week 12 and Week 52
measure: The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52
timeFrame: From Baseline to Week 8 and Week 52
measure: The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52
timeFrame: From Baseline to Week 6 and Week 52
measure: The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52
timeFrame: From Baseline to Week 4 and Week 52
measure: The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52
timeFrame: From Baseline to Week 2 and Week 52
measure: The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52
timeFrame: From Baseline to Week 1 and Week 52
Secondary outcomes:
measure: Change From Baseline in the Synovial Fluid and Proliferation at Week 52
timeFrame: From Baseline to Week 52
measure: Change From Baseline in the Synovial Fluid and Proliferation at Week 36
timeFrame: From Baseline to Week 36
measure: Change From Baseline in the Synovial Fluid and Proliferation at Week 24
timeFrame: From Baseline to Week 24
measure: Change From Baseline in the Synovial Fluid and Proliferation at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in the Synovial Fluid and Proliferation at Week 8
timeFrame: From Baseline to Week 8
measure: Change From Baseline in the Synovial Fluid and Proliferation at Week 6
timeFrame: From Baseline to Week 6
measure: Change From Baseline in the Synovial Fluid and Proliferation at Week 4
timeFrame: From Baseline to Week 4
measure: Change From Baseline in the Synovial Fluid and Proliferation at Week 2
timeFrame: From Baseline to Week 2
measure: Change From Baseline in the Synovial Fluid and Proliferation at Week 1
timeFrame: From Baseline to Week 1
measure: Change From Baseline in the Doppler Signal and Blood Flow at Week 52
timeFrame: From Baseline to Week 52
measure: Change From Baseline in the Doppler Signal and Blood Flow at Week 36
timeFrame: From Baseline to Week 36
measure: Change From Baseline in the Doppler Signal and Blood Flow at Week 24
timeFrame: From Baseline to Week 24
measure: Change From Baseline in the Doppler Signal and Blood Flow at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in the Doppler Signal and Blood Flow at Week 8
timeFrame: From Baseline to Week 8
measure: Change From Baseline in the Doppler Signal and Blood Flow at Week 6
timeFrame: From Baseline to Week 6
measure: Change From Baseline in the Doppler Signal and Blood Flow at Week 4
timeFrame: From Baseline to Week 4
measure: Change From Baseline in the Doppler Signal and Blood Flow at Week 2
timeFrame: From Baseline to Week 2
measure: Change From Baseline in the Doppler Signal and Blood Flow at Week 1
timeFrame: From Baseline to Week 1
measure: Change From Baseline in the Cartilage Damage at Week 52
timeFrame: From Baseline to Week 52
measure: Change From Baseline in the Cartilage Damage at Week 36
timeFrame: From Baseline to Week 36
measure: Change From Baseline in the Cartilage Damage at Week 24
timeFrame: From Baseline to Week 24
measure: Change From Baseline in the Cartilage Damage at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in the Cartilage Damage at Week 8
timeFrame: From Baseline to Week 8
measure: Change From Baseline in the Cartilage Damage at Week 6
timeFrame: From Baseline to Week 6
measure: Change From Baseline in the Cartilage Damage at Week 4
timeFrame: From Baseline to Week 4
measure: Change From Baseline in the Cartilage Damage at Week 2
timeFrame: From Baseline to Week 2
measure: Change From Baseline in the Cartilage Damage at Week 1
timeFrame: From Baseline to Week 1
measure: Change From Baseline in the Bone Erosion at Week 52
timeFrame: From Baseline to Week 52
measure: Change From Baseline in the Bone Erosion at Week 36
timeFrame: From Baseline to Week 36
measure: Change From Baseline in the Bone Erosion at Week 24
timeFrame: From Baseline to Week 24
measure: Change From Baseline in the Bone Erosion at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in the Bone Erosion at Week 8
timeFrame: From Baseline to Week 8
measure: Change From Baseline in the Bone Erosion at Week 6
timeFrame: From Baseline to Week 6
measure: Change From Baseline in the Bone Erosion at Week 4
timeFrame: From Baseline to Week 4
measure: Change From Baseline in the Bone Erosion at Week 2
timeFrame: From Baseline to Week 2
measure: Change From Baseline in the Bone Erosion at Week 1
timeFrame: From Baseline to Week 1
measure: Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
timeFrame: From Baseline to Week 52
measure: Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
timeFrame: From Baseline to Week 36
measure: Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
timeFrame: From Baseline to Week 24
measure: Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
timeFrame: From Baseline to Week 8
measure: Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
timeFrame: From Baseline to Week 6
measure: Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
timeFrame: From Baseline to Week 4
measure: Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
timeFrame: From Baseline to Week 2
measure: Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
timeFrame: From Baseline to Week 1
measure: Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52
timeFrame: From Baseline to Week 52
measure: Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36
timeFrame: From Baseline to Week 36
measure: Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24
timeFrame: From Baseline to Week 24
measure: Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12
timeFrame: From Baseline to Week 12
measure: Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8
timeFrame: From Baseline to Week 8
measure: Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6
timeFrame: From Baseline to Week 6
measure: Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4
timeFrame: From Baseline to Week 4
measure: Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2
timeFrame: From Baseline to Week 2
measure: Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1
timeFrame: From Baseline to Week 1
measure: Synovial Fluid and Proliferation at Week 52
timeFrame: Week 52
measure: Synovial Fluid and Proliferation at Week 36
timeFrame: Week 36
measure: Synovial Fluid and Proliferation at Week 24
timeFrame: Week 24
measure: Synovial Fluid and Proliferation at Week 12
timeFrame: Week 12
measure: Synovial Fluid and Proliferation at Week 8
timeFrame: Week 8
measure: Synovial Fluid and Proliferation at Week 6
timeFrame: Week 6
measure: Synovial Fluid and Proliferation at Week 4
timeFrame: Week 4
measure: Synovial Fluid and Proliferation at Week 2
timeFrame: Week 2
measure: Synovial Fluid and Proliferation at Week 1
timeFrame: Week 1
measure: Synovial Fluid and Proliferation at Week 0
timeFrame: Week 0 (Baseline)
measure: Doppler Signal and Blood Flow at Week 52
timeFrame: Week 52
measure: Doppler Signal and Blood Flow at Week 36
timeFrame: Week 36
measure: Doppler Signal and Blood Flow at Week 24
timeFrame: Week 24
measure: Doppler Signal and Blood Flow at Week 12
timeFrame: Week 12
measure: Doppler Signal and Blood Flow at Week 8
timeFrame: Week 8
measure: Doppler Signal and Blood Flow at Week 6
timeFrame: Week 6
measure: Doppler Signal and Blood Flow at Week 4
timeFrame: Week 4
measure: Doppler Signal and Blood Flow at Week 2
timeFrame: Week 2
measure: Doppler Signal and Blood Flow at Week 1
timeFrame: Week 1
measure: Doppler Signal and Blood Flow at Week 0
timeFrame: Week 0 (Baseline)
measure: Cartilage Damage at Week 52
timeFrame: Week 52
measure: Cartilage Damage at Week 36
timeFrame: Week 36
measure: Cartilage Damage at Week 24
timeFrame: Week 24
measure: Cartilage Damage at Week 12
timeFrame: Week 12
measure: Cartilage Damage at Week 8
timeFrame: Week 8
measure: Cartilage Damage at Week 6
timeFrame: Week 6
measure: Cartilage Damage at Week 4
timeFrame: Week 4
measure: Cartilage Damage at Week 2
timeFrame: Week 2
measure: Cartilage Damage at Week 1
timeFrame: Week 1
measure: Cartilage Damage at Week 0
timeFrame: Week 0 (Baseline)
measure: Bone Erosion at Week 52
timeFrame: Week 52
measure: Bone Erosion at Week 36
timeFrame: Week 36
measure: Bone Erosion at Week 24
timeFrame: Week 24
measure: Bone Erosion at Week 12
timeFrame: Week 12
measure: Bone Erosion at Week 8
timeFrame: Week 8
measure: Bone Erosion at Week 6
timeFrame: Week 6
measure: Bone Erosion at Week 4
timeFrame: Week 4
measure: Bone Erosion at Week 2
timeFrame: Week 2
measure: Bone Erosion at Week 1
timeFrame: Week 1
measure: Bone Erosion at Week 0
timeFrame: Week 0 (Baseline)
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
timeFrame: Week 52
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
timeFrame: Week 36
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
timeFrame: Week 24
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
timeFrame: Week 12
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
timeFrame: Week 8
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
timeFrame: Week 6
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
timeFrame: Week 4
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
timeFrame: Week 2
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
timeFrame: Week 1
measure: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0
timeFrame: Week 0 (Baseline)
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52
timeFrame: Week 52
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36
timeFrame: Week 36
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24
timeFrame: Week 24
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12
timeFrame: Week 12
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8
timeFrame: Week 8
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6
timeFrame: Week 6
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4
timeFrame: Week 4
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2
timeFrame: Week 2
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1
timeFrame: Week 1
measure: Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0
timeFrame: Week 0 (Baseline)
Other outcomes:
Locations:
city: Bari
country: Italy
facility: 11
city: Catania
country: Italy
facility: 08
city: Ferrara
country: Italy
facility: 10
city: Firenze
country: Italy
facility: 12
city: Jesi
country: Italy
facility: 01
city: Milano
country: Italy
facility: 05
city: Milano
country: Italy
facility: 13
city: Milano
country: Italy
facility: 18
city: Modena
country: Italy
facility: 07
city: Monserrato
country: Italy
facility: 23
city: Napoli
country: Italy
facility: 20
city: Padova
country: Italy
facility: 16
city: Roma
country: Italy
facility: 06
city: Roma
country: Italy
facility: 21
city: Siena
country: Italy
facility: 22
city: Torino
country: Italy
facility: 09
city: Udine
country: Italy
facility: 04
city: Verona
country: Italy
facility: 02
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Sarzi-Puttini P, Filippucci E, Adami S, Meroni PL, Batticciotto A, Idolazzi L, De Lucia O, Talavera P, Kumke T, Grassi W. Clinical, Ultrasound, and Predictability Outcomes Following Certolizumab Pegol Treatment (with Methotrexate) in Patients with Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results from the CZP-SPEED Study. Adv Ther. 2018 Aug;35(8):1153-1168. doi: 10.1007/s12325-018-0751-8. Epub 2018 Jul 24.