Rheumatoid ArthritisPhase 4SPEEDNCT01443364
Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis
A Phase 4 study testing Certolizumab pegol in people with Rheumatoid Arthritis, run by UCB Italy s.p.a. at 18 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Certolizumab pegol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 18 sitesItaly
- Study dates
- Dec 2011to May 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Italy18 sites
11
Bari
08
Catania
10
Ferrara
12
Florence
01
Iesi
05
Milan
13
Milan
18
Milan
07
Modena
23
Monserrato
20
Naples
16
Padova
06
Roma
21
Roma
22
Siena
09
Torino
04
Udine
02
Verona
About this study
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)
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Certolizumab pegol
- Keywords
- Certolizumab pegol - Cimzia, Rheumatoid Arthritis, Power Doppler Ultrasonography, Italy, Moderate-severe Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab pegolBiological
Also called CIMZIA, CZP
Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.
| Study group | Role | What they receive |
|---|---|---|
| Certolizumab pegol | Experimental | Not described Receives: Biological: Certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Measured: From Baseline to Week 12 and Week 52
The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Measured: From Baseline to Week 8 and Week 52
The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Measured: From Baseline to Week 6 and Week 52
The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Measured: From Baseline to Week 4 and Week 52
The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Measured: From Baseline to Week 2 and Week 52
The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Measured: From Baseline to Week 1 and Week 52
Secondary outcomes (114)
Change From Baseline in the Synovial Fluid and Proliferation at Week 52
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints, with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 52
Change From Baseline in the Synovial Fluid and Proliferation at Week 36
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 36
Change From Baseline in the Synovial Fluid and Proliferation at Week 24
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 24
Change From Baseline in the Synovial Fluid and Proliferation at Week 12
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 12
Change From Baseline in the Synovial Fluid and Proliferation at Week 8
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 8
Change From Baseline in the Synovial Fluid and Proliferation at Week 6
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 6
Change From Baseline in the Synovial Fluid and Proliferation at Week 4
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 4
Change From Baseline in the Synovial Fluid and Proliferation at Week 2
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 2
Change From Baseline in the Synovial Fluid and Proliferation at Week 1
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 1
Change From Baseline in the Doppler Signal and Blood Flow at Week 52
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 52
Change From Baseline in the Doppler Signal and Blood Flow at Week 36
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 36
Change From Baseline in the Doppler Signal and Blood Flow at Week 24
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 24
Change From Baseline in the Doppler Signal and Blood Flow at Week 12
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 12
Change From Baseline in the Doppler Signal and Blood Flow at Week 8
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 8
Change From Baseline in the Doppler Signal and Blood Flow at Week 6
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 6
Change From Baseline in the Doppler Signal and Blood Flow at Week 4
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 4
Change From Baseline in the Doppler Signal and Blood Flow at Week 2
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 2
Change From Baseline in the Doppler Signal and Blood Flow at Week 1
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: From Baseline to Week 1
Change From Baseline in the Cartilage Damage at Week 52
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 52
Change From Baseline in the Cartilage Damage at Week 36
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 36
Change From Baseline in the Cartilage Damage at Week 24
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 24
Change From Baseline in the Cartilage Damage at Week 12
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 12
Change From Baseline in the Cartilage Damage at Week 8
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 8
Change From Baseline in the Cartilage Damage at Week 6
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 6
Change From Baseline in the Cartilage Damage at Week 4
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 4
Change From Baseline in the Cartilage Damage at Week 2
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 2
Change From Baseline in the Cartilage Damage at Week 1
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 1
Change From Baseline in the Bone Erosion at Week 52
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 52
Change From Baseline in the Bone Erosion at Week 36
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 36
Change From Baseline in the Bone Erosion at Week 24
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 24
Change From Baseline in the Bone Erosion at Week 12
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 12
Change From Baseline in the Bone Erosion at Week 8
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 8
Change From Baseline in the Bone Erosion at Week 6
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 6
Change From Baseline in the Bone Erosion at Week 4
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 4
Change From Baseline in the Bone Erosion at Week 2
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 2
Change From Baseline in the Bone Erosion at Week 1
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: From Baseline to Week 1
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: From Baseline to Week 52
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: From Baseline to Week 36
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: From Baseline to Week 24
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: From Baseline to Week 12
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: From Baseline to Week 8
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: From Baseline to Week 6
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: From Baseline to Week 4
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: From Baseline to Week 2
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: From Baseline to Week 1
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: From Baseline to Week 52
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: From Baseline to Week 36
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: From Baseline to Week 24
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: From Baseline to Week 12
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: From Baseline to Week 8
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: From Baseline to Week 6
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: From Baseline to Week 4
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: From Baseline to Week 2
Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: From Baseline to Week 1
Synovial Fluid and Proliferation at Week 52
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 52
Synovial Fluid and Proliferation at Week 36
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 36
Synovial Fluid and Proliferation at Week 24
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 24
Synovial Fluid and Proliferation at Week 12
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 12
Synovial Fluid and Proliferation at Week 8
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 8
Synovial Fluid and Proliferation at Week 6
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 6
Synovial Fluid and Proliferation at Week 4
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 4
Synovial Fluid and Proliferation at Week 2
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 2
Synovial Fluid and Proliferation at Week 1
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 1
Synovial Fluid and Proliferation at Week 0
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 0 (Baseline)
Doppler Signal and Blood Flow at Week 52
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 52
Doppler Signal and Blood Flow at Week 36
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 36
Doppler Signal and Blood Flow at Week 24
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 24
Doppler Signal and Blood Flow at Week 12
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 12
Doppler Signal and Blood Flow at Week 8
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 8
Doppler Signal and Blood Flow at Week 6
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 6
Doppler Signal and Blood Flow at Week 4
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 4
Doppler Signal and Blood Flow at Week 2
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 2
Doppler Signal and Blood Flow at Week 1
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 1
Doppler Signal and Blood Flow at Week 0
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Measured: Week 0 (Baseline)
Cartilage Damage at Week 52
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 52
Cartilage Damage at Week 36
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 36
Cartilage Damage at Week 24
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 24
Cartilage Damage at Week 12
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 12
Cartilage Damage at Week 8
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 8
Cartilage Damage at Week 6
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 6
Cartilage Damage at Week 4
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 4
Cartilage Damage at Week 2
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 2
Cartilage Damage at Week 1
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 1
Cartilage Damage at Week 0
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 0 (Baseline)
Bone Erosion at Week 52
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 52
Bone Erosion at Week 36
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 36
Bone Erosion at Week 24
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 24
Bone Erosion at Week 12
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 12
Bone Erosion at Week 8
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 8
Bone Erosion at Week 6
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 6
Bone Erosion at Week 4
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 4
Bone Erosion at Week 2
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 2
Bone Erosion at Week 1
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 1
Bone Erosion at Week 0
The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Measured: Week 0 (Baseline)
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 52
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 36
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 24
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 12
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 8
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 6
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 4
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 2
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 1
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Measured: Week 0 (Baseline)
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 52
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 36
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 24
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 12
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 8
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 6
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 4
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 2
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 1
Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Measured: Week 0 (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Italy s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443364
- Sponsor's protocol ID
- RA0069
- Other IDs
- 2011-000385-35
- Acronym
- SPEED
- Status last verified
- Jul 2017
- First submitted
- 27 Sep 2011
- Last updated
- 15 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30043210
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01443364
- Acronym / sponsor ID
- SPEED / RA0069
- Conditions
- Rheumatoid Arthritis
- Keywords
- Certolizumab pegol - Cimzia, Rheumatoid Arthritis, Power Doppler Ultrasonography, Italy, Moderate-severe Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- UCB Italy s.p.a.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Posted 23 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Certolizumab pegol | Experimental | Biological: Certolizumab pegol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab pegolAlso: CIMZIA, CZPPrefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50. | Biological | Certolizumab pegol |
Primary outcome
The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52
Time frame: From Baseline to Week 12 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52
Time frame: From Baseline to Week 8 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52
Time frame: From Baseline to Week 6 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52
Time frame: From Baseline to Week 4 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52
Time frame: From Baseline to Week 2 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52
Time frame: From Baseline to Week 1 and Week 52
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
114 secondary outcomes
Change From Baseline in the Synovial Fluid and Proliferation at Week 52
Time frame: From Baseline to Week 52
Change From Baseline in the Synovial Fluid and Proliferation at Week 36
Time frame: From Baseline to Week 36
Change From Baseline in the Synovial Fluid and Proliferation at Week 24
Time frame: From Baseline to Week 24
Change From Baseline in the Synovial Fluid and Proliferation at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in the Synovial Fluid and Proliferation at Week 8
Time frame: From Baseline to Week 8
Change From Baseline in the Synovial Fluid and Proliferation at Week 6
Time frame: From Baseline to Week 6
Change From Baseline in the Synovial Fluid and Proliferation at Week 4
Time frame: From Baseline to Week 4
Change From Baseline in the Synovial Fluid and Proliferation at Week 2
Time frame: From Baseline to Week 2
Change From Baseline in the Synovial Fluid and Proliferation at Week 1
Time frame: From Baseline to Week 1
Change From Baseline in the Doppler Signal and Blood Flow at Week 52
Time frame: From Baseline to Week 52
Change From Baseline in the Doppler Signal and Blood Flow at Week 36
Time frame: From Baseline to Week 36
Change From Baseline in the Doppler Signal and Blood Flow at Week 24
Time frame: From Baseline to Week 24
Change From Baseline in the Doppler Signal and Blood Flow at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in the Doppler Signal and Blood Flow at Week 8
Time frame: From Baseline to Week 8
Change From Baseline in the Doppler Signal and Blood Flow at Week 6
Time frame: From Baseline to Week 6
Change From Baseline in the Doppler Signal and Blood Flow at Week 4
Time frame: From Baseline to Week 4
Change From Baseline in the Doppler Signal and Blood Flow at Week 2
Time frame: From Baseline to Week 2
Change From Baseline in the Doppler Signal and Blood Flow at Week 1
Time frame: From Baseline to Week 1
Change From Baseline in the Cartilage Damage at Week 52
Time frame: From Baseline to Week 52
Change From Baseline in the Cartilage Damage at Week 36
Time frame: From Baseline to Week 36
Change From Baseline in the Cartilage Damage at Week 24
Time frame: From Baseline to Week 24
Change From Baseline in the Cartilage Damage at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in the Cartilage Damage at Week 8
Time frame: From Baseline to Week 8
Change From Baseline in the Cartilage Damage at Week 6
Time frame: From Baseline to Week 6
Change From Baseline in the Cartilage Damage at Week 4
Time frame: From Baseline to Week 4
Change From Baseline in the Cartilage Damage at Week 2
Time frame: From Baseline to Week 2
Change From Baseline in the Cartilage Damage at Week 1
Time frame: From Baseline to Week 1
Change From Baseline in the Bone Erosion at Week 52
Time frame: From Baseline to Week 52
Change From Baseline in the Bone Erosion at Week 36
Time frame: From Baseline to Week 36
Change From Baseline in the Bone Erosion at Week 24
Time frame: From Baseline to Week 24
Change From Baseline in the Bone Erosion at Week 12
Time frame: From Baseline to Week 12
Change From Baseline in the Bone Erosion at Week 8
Time frame: From Baseline to Week 8
Change From Baseline in the Bone Erosion at Week 6
Time frame: From Baseline to Week 6
Change From Baseline in the Bone Erosion at Week 4
Time frame: From Baseline to Week 4
Change From Baseline in the Bone Erosion at Week 2
Time frame: From Baseline to Week 2
Change From Baseline in the Bone Erosion at Week 1
Time frame: From Baseline to Week 1
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
Time frame: From Baseline to Week 52
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
Time frame: From Baseline to Week 36
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
Time frame: From Baseline to Week 24
Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
Time frame: From Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30043210Sarzi-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.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Certolizumab pegol in people with Rheumatoid Arthritis, run by UCB Italy s.p.a. at 18 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52 (time frame: From Baseline to Week 12 and Week 52). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01443364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.